Radiology Device Classification Codes

LLZ Class 2

System, Image Processing, Radiological

Clearances 2150

Regulation 21 CFR 892.2050

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IYN Class 2

System, Imaging, Pulsed Doppler, Ultrasonic

Clearances 1075

Regulation 21 CFR 892.1550

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LNH Class 2

System, Nuclear Magnetic Resonance Imaging

Clearances 1071

Regulation 21 CFR 892.1000

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IYO Class 2

System, Imaging, Pulsed Echo, Ultrasonic

Clearances 862

Regulation 21 CFR 892.1560

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JAK Class 2

System, X-Ray, Tomography, Computed

Clearances 765

Regulation 21 CFR 892.1750

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IYE Class 2

Accelerator, Linear, Medical

Clearances 698

Regulation 21 CFR 892.5050

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MOS Class 2

Coil, Magnetic Resonance, Specialty

Clearances 472

Regulation 21 CFR 892.1000

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KPS Class 2

System, Tomography, Computed, Emission

Clearances 459

Regulation 21 CFR 892.1200

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ITX Class 2

Transducer, Ultrasonic, Diagnostic

Clearances 410

Regulation 21 CFR 892.1570

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MQB Class 2

Solid State X-Ray Imager (Flat Panel/Digital Imager)

Clearances 371

Regulation 21 CFR 892.1680

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QIH Class 2

Automated Radiological Image Processing Software

Clearances 334

Regulation 21 CFR 892.2050

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KPR Class 2

System, X-Ray, Stationary

Clearances 331

Regulation 21 CFR 892.1680

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OWB Class 2

Interventional Fluoroscopic X-Ray System

Clearances 299

Regulation 21 CFR 892.1650

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JAA Class 2

System, X-Ray, Fluoroscopic, Image-Intensified

Clearances 291

Regulation 21 CFR 892.1650

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MUJ Class 2

System, Planning, Radiation Therapy Treatment

Clearances 235

Regulation 21 CFR 892.5050

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IZL Class 2

System, X-Ray, Mobile

Clearances 226

Regulation 21 CFR 892.1720

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IZI Class 2

System, X-Ray, Angiographic

Clearances 195

Regulation 21 CFR 892.1600

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JAQ Class 2

System, Applicator, Radionuclide, Remote-Controlled

Clearances 190

Regulation 21 CFR 892.5700

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IZH Class 2

System, X-Ray, Mammographic

Clearances 175

Regulation 21 CFR 892.1710

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IZO Class 1

Generator, High-Voltage, X-Ray, Diagnostic

Clearances 163

Regulation 21 CFR 892.1700

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KGI Class 2

Densitometer, Bone

Clearances 146

Regulation 21 CFR 892.1170

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LMD Class 1

System, Digital Image Communications, Radiological

Clearances 142

Regulation 21 CFR 892.2020

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KXK Class 2

Source, Brachytherapy, Radionuclide

Clearances 141

Regulation 21 CFR 892.5730

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IYX Class 1

Camera, Scintillation (Gamma)

Clearances 129

Regulation 21 CFR 892.1100

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OAS Class 2

X-Ray, Tomography, Computed, Dental

Clearances 125

Regulation 21 CFR 892.1750

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LMC Class 2

Camera, Multi Format, Radiological

Clearances 119

Regulation 21 CFR 892.2040

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PGY Class 2

Display, Diagnostic Radiology

Clearances 106

Regulation 21 CFR 892.2050

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QAS Class 2

Radiological Computer-Assisted Triage And Notification Software

Clearances 87

Regulation 21 CFR 892.2080

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LHN Class 2

System, Radiation Therapy, Charged-Particle, Medical

Clearances 86

Regulation 21 CFR 892.5050

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IXW Class 2

Processor, Radiographic-Film, Automatic

Clearances 83

Regulation 21 CFR 892.1900

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OXO Class 2

Image-Intensified Fluoroscopic X-Ray System, Mobile

Clearances 79

Regulation 21 CFR 892.1650

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IXR Class 2

Table, Radiographic, Tilting

Clearances 77

Regulation 21 CFR 892.1980

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KPQ Class 2

System, Simulation, Radiation Therapy

Clearances 69

Regulation 21 CFR 892.5840

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LMA Class 2

Digitizer, Image, Radiological

Clearances 61

Regulation 21 CFR 892.2030

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LMB Class 1

Device, Digital Image Storage, Radiological

Clearances 55

Regulation 21 CFR 892.2010

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MUE Class 2

Full Field Digital, System, X-Ray, Mammographic

Clearances 54

Regulation 21 CFR 892.1715

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IXA Class 2

Cassette, Radiographic Film

Clearances 51

Regulation 21 CFR 892.1850

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IXI Class 2

Block, Beam-Shaping, Radiation Therapy

Clearances 51

Regulation 21 CFR 892.5710

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JAD Class 2

System, Therapeutic, X-Ray

Clearances 51

Regulation 21 CFR 892.5900

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IYT Class 2

System, Rebreathing, Radionuclide

Clearances 49

Regulation 21 CFR 892.1390

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QKB Class 2

Radiological Image Processing Software For Radiation Therapy

Clearances 49

Regulation 21 CFR 892.2050

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NFJ Class 2

System, Image Management, Ophthalmic

Clearances 48

Regulation 21 CFR 892.2050

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IWB Class 2

System, Radiation Therapy, Radionuclide

Clearances 42

Regulation 21 CFR 892.5750

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IZF Class 2

System, X-Ray, Tomographic

Clearances 42

Regulation 21 CFR 892.1740

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QFM Class 2

Radiological Computer-Assisted Prioritization Software For Lesions

Clearances 41

Regulation 21 CFR 892.2080

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ITY Class 1

Assembly, Tube Housing, X-Ray, Diagnostic

Clearances 40

Regulation 21 CFR 892.1760

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IYB Class 1

Tube Mount, X-Ray, Diagnostic

Clearances 40

Regulation 21 CFR 892.1770

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MYN Class 2

Analyzer, Medical Image

Clearances 40

Regulation 21 CFR 892.2070

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QDQ Class 2

Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer

Clearances 40

Regulation 21 CFR 892.2090

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NQQ Class 2

System, Imaging, Optical Coherence Tomography (Oct)

Clearances 39

Regulation 21 CFR 892.1560

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JAF Class 2

Monitor, Ultrasonic, Nonfetal

Clearances 37

Regulation 21 CFR 892.1540

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IWJ Class 1

System, Applicator, Radionuclide, Manual

Clearances 36

Regulation 21 CFR 892.5650

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EAM Class 1

Screen, Intensifying, Radiographic

Clearances 35

Regulation 21 CFR 892.1960

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IWZ Class 1

Film, Radiographic

Clearances 34

Regulation 21 CFR 892.1840

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MUI Class 2

Media, Coupling, Ultrasound

Clearances 33

Regulation 21 CFR 892.1570

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JAI Class 2

Couch, Radiation Therapy, Powered

Clearances 32

Regulation 21 CFR 892.5770

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KXJ Class 2

Table, Radiologic

Clearances 31

Regulation 21 CFR 892.1980

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KPT Class 2

Calibrator, Dose, Radionuclide

Clearances 30

Regulation 21 CFR 892.1360

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IZD Class 1

Probe, Uptake, Nuclear

Clearances 29

Regulation 21 CFR 892.1320

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IZZ Class 2

Table, Radiographic, Non-Tilting, Powered

Clearances 29

Regulation 21 CFR 892.1980

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IWE Class 1

Monitor, Patient Position, Light-Beam

Clearances 27

Regulation 21 CFR 892.5780

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IXQ Class 2

Table, Radiographic, Stationary Top

Clearances 27

Regulation 21 CFR 892.1980

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MWP Class 2

Cabinet, X-Ray System

Clearances 27

Regulation 21 CFR 892.1680

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KPX Class 2

Changer, Radiographic Film/Cassette

Clearances 26

Regulation 21 CFR 892.1860

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KPY Class 1

Shield, Protective, Personnel

Clearances 25

Regulation 21 CFR 892.6500

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IZW Class 2

Collimator, Automatic, Radiographic

Clearances 23

Regulation 21 CFR 892.1610

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POK Class 2

Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer

Clearances 22

Regulation 21 CFR 892.2060

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IXY Class 1

Holder, Radiographic Cassette, Wall-Mounted

Clearances 21

Regulation 21 CFR 892.1880

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OEB Class 2

Lung Computed Tomography System, Computer-Aided Detection

Clearances 19

Regulation 21 CFR 892.2050

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IXC Class 1

Illuminator, Radiographic-Film

Clearances 18

Regulation 21 CFR 892.1890

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JAC Class 1

System, X-Ray, Film Marking, Radiographic

Clearances 18

Regulation 21 CFR 892.1640

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IZX Class 2

Collimator, Manual, Radiographic

Clearances 17

Regulation 21 CFR 892.1610

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JWM Class 2

System, Tomographic, Nuclear

Clearances 17

Regulation 21 CFR 892.1310

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KPW Class 2

Device, Beam Limiting, X-Ray, Diagnostic

Clearances 16

Regulation 21 CFR 892.1610

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IXJ Class 1

Grid, Radiographic

Clearances 15

Regulation 21 CFR 892.1910

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IXK Class 2

System, Imaging, X-Ray, Electrostatic

Clearances 14

Regulation 21 CFR 892.1630

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OUO Class 2

Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance

Clearances 14

Regulation 21 CFR 892.1200

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IXL Class 2

Device, Spot-Film

Clearances 13

Regulation 21 CFR 892.1670

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IYZ Class 1

Bed, Scanning, Nuclear

Clearances 12

Regulation 21 CFR 892.1350

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IZJ Class 2

Camera, X-Ray, Fluorographic, Cine Or Spot

Clearances 12

Regulation 21 CFR 892.1620

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IWY Class 1

Holder, Head, Radiographic

Clearances 10

Regulation 21 CFR 892.1920

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IZP Class 2

Programmer, Changer, Film/Cassette, Radiographic

Clearances 10

Regulation 21 CFR 892.1870

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LNI Class 2

System, Nuclear Magnetic Resonance Spectroscopic

Clearances 10

Regulation 21 CFR 892.1000

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PZO Class 2

Software For Visualization Of Vascular Anatomy And Intravascular Devices

Clearances 10

Regulation 21 CFR 892.2050

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QBS Class 2

Radiological Computer Assisted Detection/Diagnosis Software For Fracture

Clearances 10

Regulation 21 CFR 892.2090

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EGY Class 2

Processor, Radiographic-Film, Automatic, Dental

Clearances 9

Regulation 21 CFR 892.1900

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KXH Class 1

Cradle, Patient, Radiologic

Clearances 9

Regulation 21 CFR 892.1830

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MUA Class 2

Bone Sonometer

Clearances 9

Regulation 21 CFR 892.1180

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QTZ Class 2

Radiological Image Processing Software For Ablation Therapy Planning And Evaluation

Clearances 9

Regulation 21 CFR 892.2050

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IWA Class 2

Source, Wire, Iridium, Radioactive

Clearances 8

Regulation 21 CFR 892.5730

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LHO Class 1

Instrument, Quality-Assurance, Radiologic

Clearances 8

Regulation 21 CFR 892.1940

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QJU Class 2

Image Acquisition And/Or Optimization Guided By Artificial Intelligence

Clearances 8

Regulation 21 CFR 892.2100

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EAK Class 1

Screen, Leaded, Operator Radiation Protector

Clearances 7

Regulation 21 CFR 892.6500

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IZG Class 2

System, X-Ray, Photofluorographic

Clearances 7

Regulation 21 CFR 892.1730

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OVB Class 2

Hydrogel Spacer

Clearances 7

Regulation 21 CFR 892.5725

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QHA Class 2

X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device

Clearances 7

Regulation 21 CFR 892.1600

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EAJ Class 1

Apron, Leaded

Clearances 6

Regulation 21 CFR 892.6500

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IWI Class 2

Source, Isotope, Sealed, Gold, Titanium, Platinum

Clearances 6

Regulation 21 CFR 892.5730

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IWS Class 1

Shield, Eye, Radiological

Clearances 6

Regulation 21 CFR 892.6500

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IXX Class 2

Processor, Cine Film

Clearances 6

Regulation 21 CFR 892.1900

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PSW Class 2

High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Liquid

Clearances 6

Regulation 21 CFR 892.1570

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IWP Class 1

Radiographic Protective Glove

Clearances 5

Regulation 21 CFR 892.6500

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IXF Class 1

Test-Pattern, Radiographic

Clearances 5

Regulation 21 CFR 892.1940

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NZT Class 2

Dosimeter, Ionizing Radiation, Implanted

Clearances 5

Regulation 21 CFR 892.5050

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IWL Class 2

System, Radiation Therapy, Neutron, Medical

Clearances 4

Regulation 21 CFR 892.5300

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IWR Class 1

Holder, Syringe, Lead

Clearances 4

Regulation 21 CFR 892.6500

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IXG Class 1

Phantom, Anthropomorphic, Radiographic

Clearances 4

Regulation 21 CFR 892.1950

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IXO Class 1

Synchronizer, Ecg / Respirator, Radiographic

Clearances 4

Regulation 21 CFR 892.1970

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IYW Class 1

Scanner, Rectilinear, Nuclear

Clearances 4

Regulation 21 CFR 892.1300

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KQA Class 2

Device, Beam Limiting, X-Ray, Therapeutic

Clearances 4

Regulation 21 CFR 892.5900

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LWI Class 2

Ultrasound, Sinus

Clearances 4

Regulation 21 CFR 892.1560

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OUJ Class 2

High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Mist

Clearances 4

Regulation 21 CFR 892.1570

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PSV Class 2

Ultrasound Bronchoscope

Clearances 4

Regulation 21 CFR 892.1550

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IWG Class 2

Seed, Isotope, Gold, Titanium, Platinum

Clearances 3

Regulation 21 CFR 892.5730

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IWQ Class 1

Curtain, Protective, Radiographic

Clearances 3

Regulation 21 CFR 892.6500

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IWX Class 1

Barrier, Control Panel, X-Ray, Movable

Clearances 3

Regulation 21 CFR 892.6500

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IYP Class 1

Phantom, Anthropomorphic, Nuclear

Clearances 3

Regulation 21 CFR 892.1370

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IYY Class 1

Synchronizer, Electrocardiograph, Nuclear

Clearances 3

Regulation 21 CFR 892.1410

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JAM Class 1

Scanner, Whole Body, Nuclear

Clearances 3

Regulation 21 CFR 892.1330

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KPZ Class 2

Generator, High Voltage, X-Ray, Therapeutic

Clearances 3

Regulation 21 CFR 892.5900

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NCS Class 2

System, Imaging, Holography, Acoustic

Clearances 3

Regulation 21 CFR 892.1550

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NWE Class 2

Colon Computed Tomography System, Computer Aided Detection

Clearances 3

Regulation 21 CFR 892.2050

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QQE Class 2

Image Management Software For Planning Of Otologic And Neurotologic Procedures

Clearances 3

Regulation 21 CFR 892.2050

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QWO Class 2

Radiology Software For Referral Of Findings Related To Fibrotic Lung Disease.

Clearances 3

Regulation 21 CFR 892.2085

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EGW Class 2

Dryer, Film, Radiographic

Clearances 2

Regulation 21 CFR 892.1900

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IWT Class 1

Shield, Gonadal

Clearances 2

Regulation 21 CFR 892.6500

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IXD Class 1

Source, Calibration, Sealed, Nuclear

Clearances 2

Regulation 21 CFR 892.1400

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IXH Class 1

Camera, Focal Spot, Radiographic

Clearances 2

Regulation 21 CFR 892.1940

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IYI Class 2

Collimator, Orthovoltage, Therapeutic X-Ray

Clearances 2

Regulation 21 CFR 892.5900

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JAB Class 2

System, X-Ray, Fluoroscopic, Non-Image-Intensified

Clearances 2

Regulation 21 CFR 892.1660

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JAO Class 2

Scanner, Fluorescent

Clearances 2

Regulation 21 CFR 892.1220

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PCS Class 2

Liver Iron Concentration Imaging Companion Diagnostic For Deferasirox

Clearances 2

Regulation 21 CFR 892.1001

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PCT Class 2

Prostate Immobilizer Rectal Balloon

Clearances 2

Regulation 21 CFR 892.5720

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QJG Class 2

Device System, Imaging, Tympanic Membrane And Middle Ear

Clearances 2

Regulation 21 CFR 892.1560

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SAO Class 2

Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density

Clearances 2

Regulation 21 CFR 892.1171

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IWD Class 2

Device, Beam Limiting, Teletherapy, Radionuclide

Clearances 1

Regulation 21 CFR 892.5750

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IWM Class 2

Synchrotron, Medical

Clearances 1

Regulation 21 CFR 892.5050

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IWN Class 1

Cassette, Measurement, Ardran-Crooks

Clearances 1

Regulation 21 CFR 892.1940

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IWO Class 1

Apron, Protective

Clearances 1

Regulation 21 CFR 892.6500

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IWW Class 1

Shield, Vial

Clearances 1

Regulation 21 CFR 892.6500

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IYD Class 2

Generator, Low Voltage, Therapeutic X-Ray

Clearances 1

Regulation 21 CFR 892.5900

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IYH Class 2

Generator, Dermatological (Grenz Ray), Therapeutic X-Ray

Clearances 1

Regulation 21 CFR 892.5900

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IYL Class 2

Collimator, Dermatological, Therapeutic X-Ray

Clearances 1

Regulation 21 CFR 892.5900

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IZS Class 2

Aperture, Radiographic

Clearances 1

Regulation 21 CFR 892.1610

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IZT Class 2

Cone, Radiographic

Clearances 1

Regulation 21 CFR 892.1610

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LQA Class 1

Media, Reusable Image

Clearances 1

Regulation 21 CFR 892.1840

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NFF Class 1

Device, Storage, Images, Ophthalmic

Clearances 1

Regulation 21 CFR 892.2010

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OMJ Class 2

Chest X-Ray Computer Aided Detection

Clearances 1

Regulation 21 CFR 892.2050

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ONL Class 2

Conformal Brachytherapy Source

Clearances 1

Regulation 21 CFR 892.5730

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OQQ Class 2

Diagnostic Ultrasonic Transducer, Robotic

Clearances 1

Regulation 21 CFR 892.1570

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POY Class 2

Post Breast Biopsy Hemostatic Breast Compression Device

Clearances 1

Regulation 21 CFR 892.1710

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QRN Class 2

Radiation Therapy Marking Device

Clearances 1

Regulation 21 CFR 892.5785

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QVA Class 2

Fludeoxyglucose F18-Guided Radiation Therapy System

Clearances 1

Regulation 21 CFR 892.5060

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QXL Class 2

Cabinet, Emission Computed Tomography System

Clearances 1

Regulation 21 CFR 892.1200

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QZL Class 2

Post-Ablation Tissue Response Prediction Software

Clearances 1

Regulation 21 CFR 892.2052

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SFV Class 2

X-Ray, Computed Tomography, Cone-Beam

Clearances 1

Regulation 21 CFR 892.1750

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SGH Class 2

Ultrasound Imaging For Vascular Access For Hemodialysis

Clearances 1

Regulation 21 CFR 892.1560

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SHN Class 1

Calibration Software For Radiology Displays

Clearances 1

Regulation 21 CFR 892.1940

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EGT Class 2

Controller, Temperature, Radiographic

Clearances 0

Regulation 21 CFR 892.1900

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HBK Class 2

Chair, Pneumoencephalographic

Clearances 0

Regulation 21 CFR 892.1820

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ITZ Class 2

Assembly, Tube Housing, X-Ray, Therapeutic

Clearances 0

Regulation 21 CFR 892.5930

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IWF Class 2

Needle, Isotope, Gold, Titanium, Platinum

Clearances 0

Regulation 21 CFR 892.5730

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IWH Class 1

Source, Teletherapy, Radionuclide

Clearances 0

Regulation 21 CFR 892.5740

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IWK Class 2

Cyclotron, Medical

Clearances 0

Regulation 21 CFR 892.5050

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IYC Class 2

Generator, Orthovoltage, Therapeutic X-Ray

Clearances 0

Regulation 21 CFR 892.5900

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IYG Class 2

Betatron, Medical

Clearances 0

Regulation 21 CFR 892.5050

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IYJ Class 2

Collimator, Low Voltage, Therapeutic X-Ray

Clearances 0

Regulation 21 CFR 892.5900

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IYK Class 2

Collimator, High Voltage, Therapeutic X-Ray

Clearances 0

Regulation 21 CFR 892.5900

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IYQ Class 1

Phantom, Flood Source, Nuclear

Clearances 0

Regulation 21 CFR 892.1380

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IZC Class 1

Camera, Positron

Clearances 0

Regulation 21 CFR 892.1110

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JAE Class 2

Microtron, Medical

Clearances 0

Regulation 21 CFR 892.5050

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JAG Class 1

Illuminator, Radiographic-Film, Explosion-Proof

Clearances 0

Regulation 21 CFR 892.1890

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JAN Class 1

Counter, Whole Body, Nuclear

Clearances 0

Regulation 21 CFR 892.1130

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JAR Class 1

Phantom, Test-Pattern, Radionuclide

Clearances 0

Regulation 21 CFR 892.1420

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LEK Class 3

Transilluminator (Diaphanoscope)

Clearances 0

Regulation 21 CFR 892.1990

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MWW Class 2

Accessory - Film Dosimetry System

Clearances 0

Regulation 21 CFR 892.5050

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NFG Class 1

Device, Communications, Images, Ophthalmic

Clearances 0

Regulation 21 CFR 892.2020

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NFH Class 2

Digitizer, Images, Ophthalmic

Clearances 0

Regulation 21 CFR 892.2030

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NFI Class 2

Device, Hardcopy, Images, Ophthalmic

Clearances 0

Regulation 21 CFR 892.2040

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NMP Class 2

Needle, Isotope, Reprocessed

Clearances 0

Regulation 21 CFR 892.5730

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OII Class 2

Arthrogram Tray

Clearances 0

Regulation 21 CFR 892.1650

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OIJ Class 2

Biopsy Needle Guide Kit

Clearances 0

Regulation 21 CFR 892.1560

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OIK Class 2

Radiology Dental Tray

Clearances 0

Regulation 21 CFR 892.1650

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OIL Class 2

Discography Kit

Clearances 0

Regulation 21 CFR 892.1730

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OIM Class 2

Mri Disposable Kit

Clearances 0

Regulation 21 CFR 892.1000

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OIN Class 2

Prostate Seeding Kit

Clearances 0

Regulation 21 CFR 892.5730

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OIO Class 2

Radiographic Contrast Tray

Clearances 0

Regulation 21 CFR 892.1680

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OIP Class 2

Radiology-Diagnostic Kit

Clearances 0

Regulation 21 CFR 892.1680

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PDK Class 2

Cream For X-Ray Attenuation

Clearances 0

Regulation 21 CFR 892.6510

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QHX Class 1

Fluoroscopic X-Ray Image Intensifier

Clearances 0

Regulation 21 CFR 892.1960

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QHY Class 2

Solid State Fluoroscopic X-Ray Imager

Clearances 0

Regulation 21 CFR 892.1650

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QUV Class 2

Phase-Changing Fiducial Marker For Radiation Therapy

Clearances 0

Regulation 21 CFR 892.5727

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QVD Class 2

Radiological Machine Learning Based Quantitative Imaging Software With Change Control Plan

Clearances 0

Regulation 21 CFR 892.2055

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QXR Class 2

Vaginal Hydrogel Packing System

Clearances 0

Regulation 21 CFR 892.5735

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RCC Class 2

C-Arm Fluoroscopic X-Ray System

Clearances 0

Regulation 21 CFR 892.1650

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RGC Class 1

X-Ray Field Indicator Light (Laser)

Clearances 0

Regulation 21 CFR 892.5780

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SEZ Class 2

Radiological Software Device To Predict Future Breast Cancer Risk

Clearances 0

Regulation 21 CFR 892.8500

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SGJ Class 2

Ultrasound Imaging System For Acquiring Images At Home By Lay Users

Clearances 0

Regulation 21 CFR 892.1590

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SHE Class 2

Radiological Software System For Delivery Date Prediction

Clearances 0

Regulation 21 CFR 892.8200

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