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
1992-10-16
KPS
1992-09-29
ARGUS PET SYSTEM
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KPS
1992-09-29
SUMMIT NUCLEAR VISION 1024RZ GAMMA CAMERA SYSTEM
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KPS
1992-09-28
SUMMIT NUCLEAR VISION T-22 GAMMA CAMERA SYSTEM
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KPS
1992-09-10
BIAD NEW DETECTOR OPTION
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KPS
1992-09-10
CARDIAC TRIAD NEW DETECTOR OPTION
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KPS
1992-08-27
MONAD NUCLEAR IMAGING SYSTEM
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KPS
1992-08-17
MULTISPECT(TM) 2 DUAL DETECTOR CAMERA SYSTEM
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KPS
1992-08-17
MULTISPECT(TM) 3 TRIPLE DETECTOR CAMERA SYSTEM
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KPS
1992-08-12
CARDIAC FIRST PASS ANALYSIS
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KPS
1992-08-11
CEDARS SINAI QUANTITATIVE THALLIUM 201 ANALYSIS
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KPS
1992-08-07
SUMMIT NUCLEAR VISION NEUROSPECT
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KPS
1992-07-17
GENESYS II
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KPS
1992-07-16
GE 4096 PLUS & GE 2048
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KPS
1992-07-10
P-LINK
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KPS
1992-04-27
VECTOR SERIES
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KPS
1992-04-27
CARDIAC TRIAD NUCLEAR IMAGING SYSTEM
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KPS
1992-04-27
ECAT EXACT HR MODEL 961
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KPS
1992-04-16
OPTIMA NUCLEAR TOMOGRAPHY STYSTEM
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KPS
1992-02-27
CEDARS-SINAI QUANTITATIVE THALLIUM-201 ANALYSIS
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KPS
1992-02-27
APEX HELIX - A
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KPS
1991-12-17
SOPHY NXT
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KPS
1991-11-27
CEQUAL(TM) QUANITATIVE ANALYSIS CARDIOLITE(R) SPEC
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KPS
1991-11-27
ECAT SCANNER (MODEL 921)
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KPS
1991-11-22
CEQUAL(TM)
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KPS
1991-10-30
CARDIOFOCAL COLLIMATOR
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KPS
1991-10-28
VISION (NUCLEAR MEDICINE COMPUTER)
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KPS
1991-10-23
MULTISPECT 2 DUAL DETECTOR CAMERA SYSTEM
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KPS
1991-10-23
CIRRUS GAMMA CAMERA
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KPS
1991-09-06
VISIONPRO
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KPS
1991-09-06
ACQUPRO
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KPS
1991-08-19
EAGLE NUCLEAR IMAGING SYSTEM
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KPS
1991-06-17
MULTISPECT 3 TRIPLE DETECTOR CAMERA SYSTEM
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KPS
1991-05-17
ECAT SCANNER
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KPS
1991-05-09
POSICAM SYSTEM MODEL 6.5 POSICAM-HZ SYSTEM
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KPS
1991-04-16
EMISSION TOMOGRAPHY CAROUSEL
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KPS
1990-05-02
MICRODELTA, GATED SINGLE PHOTON (SPECT) PACKAGE
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KPS
1990-04-04
DIACAM GAMMA CAMERA SYSTEM
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KPS
1989-12-22
ASPECT GAMMA CAMERA
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KPS
1989-11-15
POSITRON EMISSION COMPUTED TOMOGRAPH SET-1400W
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KPS
1989-11-02
MODIFIED POSICAM SYSTEM MODEL 6.5
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KPS
1989-08-23
PEGASYS NUCLEAR MEDICINE IMAGING COMPUTER
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KPS
1989-07-20
BIAD NUCLEAR IMAGING SYSTEM
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KPS
1989-04-17
NEUROFOCAL COLLIMATOR
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KPS
1989-04-13
PENN-PET SCANNER
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KPS
1988-12-22
ADAC VIEWPOINT (ADDITIONAL SOFTWARE)
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KPS
1988-11-16
SINGLE PHOTON SET 031 & AZ-701-NTS-SP EMISSION
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KPS
1988-01-19
TRIAD NUCLEAR IMAGING SYSTEM
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KPS
1987-07-10
TOMOMATIC 232
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KPS
1986-04-16
NON-CIRCULAR ORBITING OPTION
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KPS
1985-09-20
TOMOMATIC 564
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KPS
1985-09-03
POSICAM TM(MODEL 3.2,4.3,6.5)
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KPS
1984-11-21
SUPERPETT
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KPS
1981-04-10
NEURO-ECAT
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KPS
1981-01-15
GE RT/PLAN MAGNETIC TAPE DRIVE OPTION
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KPS
1979-09-17
ADAC TOMOGRAPHY OPTION
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KPS
1979-02-15
TOMOGRAPHIC PROGRAMS
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KPS
1978-11-03
TOMOGSCANNER 2
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KPS
1977-02-28
RADIONUCLIDE COMPUTED TOMOGRAPHY SYS.
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