System, Tomography, Computed, Emission
FDA product code KPS · 459 cleared devices
Class 2
Radiology
- Regulation
- 21 CFR 892.1200
- Review panel
- RA
- Implant
- No
- Life sustaining
- No
- Third party review
- Yes
- GMP exempt
- No
- Clearance span
- 1977-02-28 – 2026-09-11
KPS
1998-12-23
KPS
1998-11-16
FORTE
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KPS
1998-11-04
DIGIRAD 2020TC SPECT IMAGING SYSTEM
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KPS
1998-10-06
E.CAM EXTRA HIGH ENERGY COLLIMATOR
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KPS
1998-09-29
AUTOMATED MEDICAL REPORT WRITER
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KPS
1998-09-25
TRANSVIEW (TRANSMISSION SYSTEM),MODEL NDTR-701A
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KPS
1998-09-17
HAMAMATSU PET SCANNER, MODEL SHR-22000
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KPS
1998-09-02
NUCAMMA RX
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KPS
1998-09-02
NUCAMMA R+
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KPS
1998-07-13
VPC-94 ULTRA HIGH ENERGY COLLIMATERS MODEL NUMBERS 480-685-9402
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KPS
1998-06-29
VANTAGE 3.0 INSYNCH
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KPS
1998-06-08
E.CAM LSO 311 PET/SPECT SYSTEM
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KPS
1998-06-04
VTRANSACT: ATTENUATION CORRECTION SYSTEM FOR DUAL-HEAD VARIABLE ANGLE GAMMA CAMERA
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KPS
1998-06-04
EMORY CARDIAC TOOL BOX
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KPS
1998-06-04
3D-MSPECT
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KPS
1998-05-06
AUTOQUANT QUANTITATIVE PERFUSION SPECT (QPS) & QUANTITATIVE GATED SPECT (QGS)
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KPS
1998-02-25
ECAT PET SCANNERS
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KPS
1998-02-13
NUMASTATION
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KPS
1998-01-21
QUEST PET IMAGING SYSTEM
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KPS
1997-11-25
IMAGE FUSION AND REVIEW SYSTEM
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KPS
1997-10-23
MCD-AC
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KPS
1997-10-14
VCAR OPTION TO THE DST AND DST-XL GAMMA CAMERAS AND VISION POWERSTATION COMPUTER
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KPS
1997-10-03
EXPERT-XL TOTAL BODY ACQUISITION AND ANALYSIS SOFTWARE
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KPS
1997-09-23
MULTISPECT 2 511 KEV COLLIMATOR
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KPS
1997-09-08
CEQUAL-QUANTITATIVE ANALYSIS FOR CARDIOLITE EXECUTING ON THE MEDASYS DIGITAL SYSTEMS COMPUTER
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KPS
1997-09-04
E. CAM COINCIDENCE MODE (CM)
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KPS
1997-08-08
VANTAGE 2.1 EXSPECT
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KPS
1997-06-13
CARDIOMATCH
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KPS
1997-05-29
511 KEV COLLIMATOR
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KPS
1997-04-24
CLINICAL DIAGNOSTIC SOFTWARE
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KPS
1997-04-11
ISOCAM I (SINGLE HEAD GAMMA CAMERA)/ISOCAM II (DUAL HEAD GAMMA CAMERA)
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KPS
1997-03-31
E. CAM PROFILE ATTENUATION CORRECTION
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KPS
1997-03-11
VCAR OPTION TO VISION FX-80 GAMMA CAMERA AND POWER STATION
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KPS
1997-02-28
ISOCAM II (DUAL HEAD GAMMA CAMERA)
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KPS
1997-02-26
UHE COLLIMATOR (210591)
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KPS
1997-02-21
PRISM XPVT SYSTEM (210823)
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KPS
1997-02-10
PROTEC (1024)
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KPS
1997-01-10
VOLMETRIC COINCIDENCE DETECTION SYSTEM
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KPS
1997-01-07
GENIE PROCESSING AND REVIEW WORKSTATION
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KPS
1996-12-23
SCATTER CORRECTION VOLUME SOFTWARE MODEL NSSC-020A
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KPS
1996-11-27
QUASAR RECOVERY IMAGING PACKAGE
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KPS
1996-11-12
TRIAD 88 NUCLEAR IMAGING SYSTEM
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KPS
1996-11-12
MONAD NUCLEAR IMAGING SINGLE PHOTON EMISSION COMPUTED TOMOGRAPHY SYSTEM
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KPS
1996-11-12
BIAD NUCLEAR IMAGING SYSTEM
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KPS
1996-11-12
CARDIAC TRIAD NUCLEAR IMAGING SINGLE PHOTON EMISSION COMPUTED TOMOGRAPHY SYSTEM
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KPS
1996-11-12
QUANTEM
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KPS
1996-10-28
GAMMACON IMAGE TRANSLATION SYSTEM
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KPS
1996-10-15
ECAT EXACT & ECAT EXACT HR+
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KPS
1996-10-10
MILLENNIUM MT AND MILLENNIUM MG NUCLEAR MEDICINE SYSTEMS
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KPS
1996-09-20
STEP OPTION TO PRISM 2000
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KPS
1996-09-12
POSITRON COINCIDENCE DETECTION
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KPS
1996-09-04
GATED MIBI 3-D EJECTION FRACTION PROCESSING
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KPS
1996-07-23
PRISM 3000XPV SYSTEM (210714)
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KPS
1996-03-29
XENON OPTION TO PRISM 3000
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KPS
1996-02-26
SPECTEF PROTOCOL
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KPS
1996-01-18
TRANSMISSION ATTENUATION CORRECTION (TAC) PACKAGE
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KPS
1995-12-22
HITACHI SPECTRADIGITAL SERIES GAMMA CAMERA SYSTEMS
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KPS
1995-12-22
SPECTRADIGITAL SERIES V250DSP
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KPS
1995-11-24
VERTEX EPIC MCD
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KPS
1995-11-22
VARICAM
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KPS
1995-11-22
INSPECT/PROSPECT
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KPS
1995-10-24
NUQUEST NUCLEAR MEDICINE COMPUTER
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KPS
1995-10-24
SCINTRON IV
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KPS
1995-09-26
TRANSACT: ATTENUATION CORRECTION SYSTEM FOR THE APEX CARDIAL GAMMA CAMERA
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KPS
1995-08-23
IP500 NUCLEAR GAMMA CAMERA SYSTEM
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KPS
1995-07-03
PHOENIX PLUS & BASE NUCLEAR MEDICINE SINGLE DETECTOR SYSTEMS
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KPS
1995-04-26
VANTAGE, FOR ADAC GAMMA CAMERAS
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KPS
1995-04-07
PENN-PET SCANNER
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KPS
1995-03-31
ATTENUATION CORRECTION
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KPS
1995-03-23
GALEN
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KPS
1995-03-21
PRISM 1500XP NUCLEAR GAMMA CAMERA SYSTEM
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KPS
1995-02-22
NON-UNIFORM ATTENUATION CORRECTION SYSTEM
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KPS
1995-01-05
DST-XL
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KPS
1994-12-23
COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE FUNCTION
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KPS
1994-11-29
ADVANCE ANALYSIS SOFTWARE
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KPS
1994-09-30
ISOCAM II (DUAL HEAD GAMMA CAMERA)
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KPS
1994-09-23
PHOENIX NUCLEAR MEDICINE PROCESSING COMPUTER
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KPS
1994-09-23
PATLAK & FDG AUTORADIOGRAPHIC
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KPS
1994-09-16
VISIONLINK DICOM MODULE
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KPS
1994-09-16
CEQUAL-QUANTITATIVE ANALYSIS
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KPS
1994-07-29
SNAC (SIEMENS NUCLEAR ACQUISITION COMPUTER)
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KPS
1994-05-13
PRISM 3000 NUCLEAR GAMMA CAMERA SYSTEM MODIFICATION
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KPS
1994-05-03
QUANTITATIVE HEART
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KPS
1994-03-29
MAGELLAN
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KPS
1994-03-22
ECAT PRT
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KPS
1994-02-25
SUMMIT NUCLEAR VISION FX 20 SERIES GAMMA CAMERA SYSTEMS
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KPS
1993-11-03
DELTAMANAGER
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KPS
1993-11-01
PICTURE ARCHIVING & COMMUNICATIONS SYSTEMS(PACS)
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KPS
1993-11-01
VISIONLINK INTERFILE CONVERSION SOFTWARE
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KPS
1993-08-05
C-EQUAL(CEDERS-EMORY QUANTITIVE ANALYSIS)
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KPS
1993-07-27
GCA-7200A
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KPS
1993-07-08
POSICAM-HZ & POSICAM-HZL
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KPS
1993-06-21
SIM-400 SYSTEM
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KPS
1993-06-08
PENN-PET SCANNER
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KPS
1993-06-08
CORT-EX
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KPS
1993-01-28
SYSTEM, TOMOGRAPHIC, NUCLEAR
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KPS
1993-01-12
EQUILIBRIUM RADIONUCLIDE ANGIOCARDIORAPHY ANALYSIS
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KPS
1992-12-11
M-LINK
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KPS
1992-12-07
OPTITRACK
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KPS
1992-12-03
MAXXUS
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