Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Accelerator, Linear, Medical

FDA product code IYE · 698 cleared devices

Class 2 Radiology

Regulation: 21 CFR 892.5050
Review panel: RA
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1977-08-03 – 2026-09-16

IYE 1997-06-13

VERIDOSE DIODES

Applicant Victoreen, Inc.

K number K964785

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IYE 1997-06-06

PRONE BREAST POSITIONING BOARD, MODEL #37-018

Applicant Victoreen, Inc.

K number K971382

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IYE 1997-05-12

BRAINLAB MICRO MULTI-LEAF COLLIMATOR

Applicant Brainlab Med. Computersysteme GmbH

K number K970586

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IYE 1997-05-12

DYNAMIC WEDGE

Applicant Mitsubishi Electronics America, Inc.

K number K970564

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IYE 1997-04-24

ACCESSORIES TO THE STEREOTACTIC BODY FRAM

Applicant Elekta Instrument AB

K number K970291

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IYE 1997-04-15

EXL-12SP,12DP,15DP,20DP LINAC

Applicant Mitsubishi Electronics America, Inc.

K number K970137

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IYE 1997-04-01

LINAC SCALPEL FLOORSTAND

Applicant Surgical Navigation Technologies, Inc.

K number K964517

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IYE 1997-03-21

DECISION SUPPORT SYSTEM (FOR RADIATION ONCOLOGY)

Applicant Multidata Systems International Corp.

K number K964167

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IYE 1997-02-11

BEAM BLOCK TRAYS

Applicant Aktina Medical Physics Corp.

K number K964840

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IYE 1997-02-06

MLC FIT

Applicant Impac Medical Systems, Inc.

K number K962335

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IYE 1997-02-04

PORTPRO ELECTRONIC PORTAL IMAGING SYSTEM

Applicant Eliav , Ltd.

K number K964485

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IYE 1997-01-03

RFA-300, LDA UTILITY

Applicant Scanditronix Medical AB

K number K961400

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IYE 1996-12-23

THE NOMOS TALON POSITIONING AND IMMOBILIZATION SYSTEM

Applicant Nomos Corp.

K number K963860

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IYE 1996-12-06

PHILIPS SLI SERIES LINEAR ACCELERATOR

Applicant Philips Medical Systems, Inc.

K number K963624

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IYE 1996-11-18

PEACOCK SYSTEM

Applicant Nomos Corp.

K number K963258

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IYE 1996-11-12

LINAC SCALPEL TREATMENT PLANNING SYSTEM

Applicant Surgical Navigation Technologies, Inc.

K number K962792

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IYE 1996-11-08

THERAPLAN PLUS

Applicant Theratronics, Inc.

K number K954679

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IYE 1996-11-07

CASS SYSTEM (MODIFICATION)

Applicant Medical Instrumentation & Diagnostics Corp.(Midco)

K number K961484

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IYE 1996-09-09

BREAST TREATMENT AID M200

Applicant S. and H. Engineering, Inc.

K number K962487

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IYE 1996-08-23

RPS-50 BEAM SCANNER

Applicant Sofield Science Services, Inc.

K number K962080

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IYE 1996-08-22

GILL-THOMAS-COSMAN(GTC) DENTAL TRAY

Applicant Radionics Software Applications, Inc.

K number K962155

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IYE 1996-08-09

HEAD RETAINING DEVICE

Applicant S. and H. Engineering, Inc.

K number K961467

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IYE 1996-08-06

MULTI LEAF COLLIMATOR

Applicant Mitsubishi Intl. Corp.

K number K961214

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IYE 1996-08-05

BRAINLAB CT/X-RAY LOCALIZER

Applicant Brainlab Med. Computersysteme GmbH

K number K954861

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IYE 1996-08-01

MRTOFLM COMPUTER PROGRAM

Applicant Northwest Medical Physics Equipment, Inc.

K number K960293

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IYE 1996-06-19

BREAST TREATMENT AID

Applicant S. and H. Engineering, Inc.

K number K961170

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IYE 1996-06-17

0.6CC IONIZATION CHAMBER - WATERPROOF 0.6CC IONIZATION CHAMBER

Applicant Ptw-New York Corp.

K number K961208

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IYE 1996-05-28

KODAK EC-L CASSETTE

Applicant Eastman Kodak Company

K number K960834

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IYE 1996-04-23

STEREOTACTIC BODY FRAME

Applicant Elekta Instrument AB

K number K960338

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IYE 1996-04-22

THERAVIEW

Applicant Infimed, Inc.

K number K960510

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IYE 1996-04-22

PID-1 PRECISION INTELLIGENT DOSIMETER

Applicant Gammex, Inc.

K number K954564

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IYE 1996-04-09

PEACOCK PLAN

Applicant Nomos Corp.

K number K940663

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IYE 1996-04-08

PINNACLE3 APEX

Applicant Adac Laboratories

K number K951581

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IYE 1996-03-15

VARIS PORTALVISION

Applicant Varian Assoc., Inc.

K number K955774

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IYE 1996-02-26

COMPUTE-RX PLAN PC3D

Applicant Medicalibration Physics Consultant Services, Inc.

K number K953508

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IYE 1996-02-02

VARIAN MULTILEAF COLLIMATOR

Applicant Varian Assoc., Inc.

K number K943224

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IYE 1996-01-17

EXL-12SP & 12DP LINAC

Applicant Mitsubishi Intl. Corp.

K number K952314

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IYE 1996-01-05

ACRYSTEEL BLOCKING TRAY

Applicant Medtec, Inc.

K number K954705

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IYE 1995-12-22

RADIOSURGERY VERIFICATION PHANTOM

Applicant The Phantom Laboratory, Inc.

K number K954634

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IYE 1995-12-21

EXL-15DP & 20-DP LINAC

Applicant Mitsubishi Intl. Corp.

K number K952108

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IYE 1995-12-21

ALDERSON BREST DOSIMETRY SYSTEM

Applicant Radiology Support Devices, Inc.

K number K946074

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IYE 1995-12-05

PTW-MP3 & PTW-MP3S AUTOMATIC WATER PHANTOM

Applicant Ptw-New York Corp.

K number K954165

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IYE 1995-11-14

PLATO-SRS(STEREO RADIOSURGERY TREATMENT PLANNING SYS)

Applicant Nucletron Corp.

K number K940001

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IYE 1995-10-25

PHILIPS MULTI LEAF PRESCRIPTION ENTRY SYSTEM (MLP)

Applicant Philips Medical Systems, Inc.

K number K953570

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IYE 1995-10-25

XKNIFE-3

Applicant Radionics Software Applications, Inc.

K number K953482

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IYE 1995-10-07

UNIDOS UNIVERSAL DOSIMETER MODEL 10002-WITH TNC CONNECTOR, 10005-WITH BNT CONNECTOR

Applicant Ptw-New York Corp.

K number K951764

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IYE 1995-09-22

PERI-PUSHER

Applicant Diacor, Inc.

K number K953046

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IYE 1995-09-15

PAINTED WEDGE & ROD BREAST BOARD

Applicant Medtec, Inc.

K number K952729

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IYE 1995-08-25

HEAD IMMOBILIZATION APPARATUS

Applicant Northwest Medical Physics Center

K number K941118

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IYE 1995-08-23

RAPID-FOAM

Applicant The Soule Co., Inc.

K number K952457

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IYE 1995-08-16

HERCULES RADIATION THERAPY COUCH

Applicant Precision Therapy Intl., Inc.

K number K950061

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IYE 1995-08-09

MED-TEC REDISET

Applicant Medtec, Inc.

K number K952189

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IYE 1995-07-21

PLANET THERMOPLASTIC IMMOBILIZATION SYSTEM

Applicant S & S X-Ray Products, Inc.

K number K944040

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IYE 1995-07-13

MED-TEC TRAY ADAPTER

Applicant Medtec, Inc.

K number K950075

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IYE 1995-07-12

MED-TEC RADIO THERAPY TREATMENT CHAIR

Applicant Medtec, Inc.

K number K951947

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IYE 1995-07-12

MED-TEC TESTICULAR SEPARATOR

Applicant Medtec, Inc.

K number K951679

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IYE 1995-07-12

WELLHOFER WP700 V. 3.2

Applicant Medical Physics Instrumentation, Inc.

K number K945321

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IYE 1995-07-06

MED-TEC REDI-FOAM

Applicant Medtec, Inc.

K number K951808

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IYE 1995-06-28

MED-TEC KNEE CRUTCH

Applicant Medtec, Inc.

K number K951717

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IYE 1995-06-19

PULSE KLYSTRON AMPLIFIFER (L-5822-90)

Applicant Litton Systems, Inc.

K number K951143

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IYE 1995-06-16

PULSE KLYSTRON AMPLIFIER (L-5822-00)

Applicant Litton Systems, Inc.

K number K951142

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IYE 1995-06-09

MEDICAL LINEAR ACCELERATOR

Applicant Accelerator Systems Intl., Inc.

K number K935615

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IYE 1995-06-05

BRAINLAB MASK SYSTEM

Applicant Brainlab Med. Computersysteme GmbH

K number K945903

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IYE 1995-05-30

HIP FIXATION SYSTEM

Applicant Medtec, Inc.

K number K950866

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IYE 1995-05-15

IMAGERT

Applicant Impac Medical Systems, Inc.

K number K942346

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IYE 1995-05-12

MICRO MULTILEAF COLLIMATOR

Applicant Leibinger F.L. Fischer

K number K943714

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IYE 1995-05-05

VARIAN MULTILEAF COLLIMATOR, RELEASE 4.0

Applicant Varian Assoc., Inc.

K number K926449

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IYE 1995-02-16

IORT SYSTEM

Applicant Northwest Medical Physics Center

K number K933117

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IYE 1995-02-08

GILL-THOMAS-COSMAN (GTC) RELOCATABLE HEAD HOLDER SYSTEM WITH DEPTH CONFIRMATION HELMET(DH-1)

Applicant Radionics, Inc.

K number K934523

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IYE 1995-02-01

PHILIPS IMPROVED CHECK RADIOGRAPH OPTION

Applicant Philips Medical Systems North America, Inc.

K number K943464

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IYE 1995-01-24

COMPU-CUTTER THERAPEUTIC SHIELDING CUTTING DEVICE

Applicant Huestis Machine Corp.

K number K940145

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IYE 1994-12-15

RF DRIVER, RADIO FREQUENCY DRIVER

Applicant Pro-Comm, Inc.

K number K943406

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IYE 1994-12-09

MODEL 37-720 DUAL DIODE DOSIMETRY SYSTEM

Applicant Victoreen, Inc.

K number K940660

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IYE 1994-12-07

MOTORIZED DEPTH DOSE APPARATUS

Applicant Medtec, Inc.

K number K943199

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IYE 1994-11-22

BLOCKING TRAY

Applicant Medtec, Inc.

K number K944315

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IYE 1994-10-04

PINNACLE 3

Applicant Adac Laboratories

K number K926008

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IYE 1994-09-23

VARIAN ORIGAMI, VERSION 1.0

Applicant Varian Assoc., Inc.

K number K932501

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IYE 1994-09-23

VARIAN RMS-2000, RELEASE 2.5

Applicant Varian Assoc., Inc.

K number K930513

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IYE 1994-09-16

STP COMPLETE MODULE SET AND MASK FIXATION SYSTEM

Applicant Leibinger GmbH

K number K924685

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IYE 1994-09-02

ADVANCED THERAPY DOSIMETER

Applicant Keithley Instruments, Inc.

K number K942083

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IYE 1994-08-29

THERPAC RADIOTHERAPY TREATMENT PLANNING SYSTEM

Applicant Pinecliff Assoc.

K number K930506

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IYE 1994-08-09

RFA A-300

Applicant Scanditronix, Inc.

K number K934303

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IYE 1994-08-09

VARIAN C/D-SERIES CLINACS (CLINAC 600 C/D)

Applicant Varian Assoc., Inc.

K number K926321

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IYE 1994-07-29

DPD-3

Applicant Scanditronix, Inc.

K number K942092

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IYE 1994-07-29

RIT 113 FILM ANALYSIS SYSTEM

Applicant Radiological Imaging Technology, Inc.

K number K935928

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IYE 1994-07-29

NUCLEAR ASSOC 37-08 SER, RAYCAST HP RADIO IMMOB SYST

Applicant Victoreen, Inc.

K number K935435

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IYE 1994-07-26

THERAPLAN V05B/ TP-11 V09B

Applicant Theratronics, Inc.

K number K940237

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IYE 1994-07-22

BRAINLAB LINAC HARDWARE

Applicant Brainlab Med. Computersysteme GmbH

K number K934657

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IYE 1994-07-18

MED-TEC BREAST SUPPORT SYSTEM

Applicant Medtec, Inc.

K number K942282

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IYE 1994-07-18

MED-TEC, INC. BREAST BOARD, MT-200

Applicant Medtec, Inc.

K number K935412

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IYE 1994-07-18

MED-TEC, INC. BREAST BOARD, MT-250

Applicant Medtec, Inc.

K number K935411

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IYE 1994-07-18

VAC-LOK IMMOBILIZATION SYSTEM

Applicant Medtec, Inc.

K number K935300

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IYE 1994-07-18

UNI-FRAME HEAD IMMOBILIZATION SYSTEM

Applicant Medtec, Inc.

K number K933227

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IYE 1994-06-03

TN-RD-50

Applicant Keithley Instruments, Inc.

K number K932598

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IYE 1994-05-26

AQUAPLAST

Applicant Wfr/Aquaplast Corp.

K number K935067

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IYE 1994-05-25

THERAC 25

Applicant Theratronics, Inc.

K number K922276

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IYE 1994-04-15

POSICAST IMMOBILIZATION SYSTEM

Applicant Huestis Machine Corp.

K number K926187

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IYE 1994-04-07

HANDI-FOAM

Applicant Medtec, Inc.

K number K935021

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IYE 1994-03-16

ARM RADIATION BEAM SCANNER

Applicant Advanced Radiation Measurements, Inc.

K number K933558

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IYE 1994-01-05

RADIATION TREATMENT FOR CANCER PATIENTS

Applicant Northwest Medical Physics Center

K number K930182

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