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
2004-11-03
KPS
2004-10-29
AUTOSPECS
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KPS
2004-10-29
C-PET PLUS IMAGING SYSTEM
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KPS
2004-10-04
BP-SPECT V1.O
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KPS
2004-10-01
LSO PET/CT HIREZ 64
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KPS
2004-09-17
SCEPTREP3 PET/CT
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KPS
2004-09-08
DISCOVERY ST PET/CT IMAGING SYSTEM WITH AN ALTERNATE DETECTOR OPTION
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KPS
2004-08-20
MEDX NUQUEST - INTECAM SPECT 37-75 SYSTEM
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KPS
2004-07-29
GEMINI PET/CT IMAGING SYSTEM
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KPS
2004-07-22
IMAGENMD
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KPS
2004-06-22
GE DISCOVERY ST
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KPS
2004-06-17
NEUROQ - PET DP
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KPS
2004-06-15
GE DISCOVERY ST SYSTEM
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KPS
2004-06-07
ECAT HRRT
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KPS
2004-05-24
GRIFFIN SPECT/CT IMAGING SYSTEM
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KPS
2004-05-21
SYNTEGRA
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KPS
2004-05-17
SIEMENS ENHANCED IMAGING SYSTEM
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KPS
2004-04-07
MODIFICATION TO GE DISCOVERY LS SYSTEM
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KPS
2004-03-24
CARDIOMD-AC
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KPS
2004-03-11
WBR-FHR, WBR-FWB
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KPS
2004-02-25
AUTOQUANT PLUS
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KPS
2004-02-02
MOBILE COMPACT DIGITAL CARDIAC CAMERA
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KPS
2004-01-30
EMORY CARDIAC TOOLBOX VERSION 2.6
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KPS
2004-01-20
MOBILE SINGLE CIRCULAR CAMERA (MSC) & MOBILE DIGITAL CARDIAC CAMERA (MDCC)
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KPS
2003-12-30
MYOLIGHT
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KPS
2003-12-24
APEX DETECTOR ELECTRONICS & ACQUISITION INTERFACE, MODEL XL-4
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KPS
2003-12-19
ALLEGRO IMAGING SYSTEM
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KPS
2003-12-17
MODIFICATION TO: NUCAMMA RX
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KPS
2003-12-12
VANTAGE PRO ATTENUATION CORRECTION DEVICE
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KPS
2003-12-12
CLARITY PET
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KPS
2003-11-20
LSO PET/CT HIREZ AND LSO PET/CT 16 HIREZ
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KPS
2003-11-12
COMPACT DIGITAL CARDIAC CAMERA (CDCC)
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KPS
2003-10-22
FORTE GAMMA CAMERA SYSTEM
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KPS
2003-08-25
MODIFICARION TO WACKERS-LIU CQ SOFTWARE
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KPS
2003-08-18
PEM 2400 PET SCANNER
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KPS
2003-07-18
MODIFICATION TO WBR, MODEL HR
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KPS
2003-07-11
GEMINI 16
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KPS
2003-06-20
ULTRA-HIGH ENERGY GENERAL PURPOSE COLLIMATOR (UHGP) [FOR CARDIAC IMAGING]
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KPS
2003-06-20
C.CAM
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KPS
2003-06-17
SKYLIGHT IMAGING SYSTEM
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KPS
2003-04-09
WBR, MODEL HR
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KPS
2003-02-11
GE MOBILE DISCOVERY ST PET CT IMAGING SYSTEM
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KPS
2003-02-05
CARDIUS-1 AND CARDIS-2
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KPS
2003-02-04
GE DISCOVERY LS SYSTEM
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KPS
2002-12-11
GE PHOTON ENERGY RECOVERY (PER) OPTION
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KPS
2002-11-25
ECAT PET/CT; ECAT LSO PET/CT; ECAT LSO PET/CT 16
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KPS
2002-11-22
CEDARS-SINAI MOTION CORRECTION (MOCO) SOFTWARE, MODEL 111005
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KPS
2002-11-08
ECAT LSO PET/CT 16
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KPS
2002-09-19
GE QUASAR NUCLEAR MEDICINE SYSTEM
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KPS
2002-09-12
GE ROAD WARRIOR PET CT IMAGING SYSTEM
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KPS
2002-08-14
ECAT VISION PET SCANNER, MODELS 3000 & 5000
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KPS
2002-08-06
MOBILE MILLENNIUM MG SYSTEM
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KPS
2002-07-12
MPOWER, MODEL 712 SERIES
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KPS
2002-06-17
CARDIOSPECT D90/CARDIO CAM
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KPS
2002-06-13
HERMES HDAQ ACQUISITION STATION AND HERMES WORKSTATION, VER. 3.4
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KPS
2002-04-23
NORTHWESTERN GATED BLOOD POOL SPECT (NUMUGAS)
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KPS
2002-03-04
NEUROSPECTQUAD GAMMA CAMERA
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KPS
2002-02-22
EMORY CARDIAC TOOLBOX 2.1 EXECUTING ON NUCLEAR MEDICINE COMPUTERS
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KPS
2002-01-28
BCC GAMMA CAMERA
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KPS
2001-11-06
MODIFICATION TO SKYLIGHT IMAGING SYSTEM
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KPS
2001-10-31
MODIFICATION TO: ECAT LSO PET/CT SCANNER
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KPS
2001-09-18
GE POSITRACE/DISCOVERY VI PET/CT DUAL MODE ONCOLOGY SCANNER
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KPS
2001-09-06
GE VISION NUCLEAR MEDICINE WORKSTATION
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KPS
2001-06-15
QUANTITATIVE GATED SPECT (QGS), QUANTITATIVE PERFUSION SPECT (QPS)
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KPS
2001-06-08
CARDIOCAM MODEL 9CSY0799
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KPS
2001-04-27
CEDARS-SINAI BPGS AND MOCO
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KPS
2001-02-21
NUCAMMA BI90
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KPS
2001-02-13
ORBITER II CCI/SPECT ORBITER II CCI/SPECT
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KPS
2001-01-19
QPS (QUANTITATIVE PERFUSION SPECT), QGS (QUANTITATIVE GATED SPECT)
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KPS
2000-12-22
GE ADVANCE NXI PET SYSTEM
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KPS
2000-12-21
QPS/BPGS/MOCO PROCESSING APPLICATIONS FOR ENTEGRA WORKSTATION
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KPS
2000-12-13
ECAT PET SCANNER
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KPS
2000-11-16
ALLEGRO TB, ALLEGRO N
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KPS
2000-11-16
ECAT ACCEL PET SCANNER
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KPS
2000-10-31
ECAT PET SCANNER
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KPS
2000-10-20
WACKERS-LIU CQ SOFTWARE
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KPS
2000-09-15
DS DS I-SERIES
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KPS
2000-08-25
POSITRACE DUAL MODE PET/CT ONCOLOGY SYSTEM
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KPS
2000-07-17
MEDICAL IMAGE MERGE (MIM)
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KPS
2000-06-30
UNICORN MODEL SYS0630
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KPS
2000-06-20
3D-MSPECT
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KPS
2000-04-05
SKYLIGHT IMAGING SYSTEM
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KPS
2000-03-07
CODE AC: ATTENUATION CORRECTION SYSTEM FOR DUAL-HEAD VARIABLE-ANGLE GAMMA CAMERA WITH COINCIDENCE OPTION (CODE)
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KPS
2000-02-10
MEDX INTECAM INTERFACE
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KPS
1999-12-03
AUTOMATIC IMAGE REGISTRATION SOFTWARE, MODEL NSFU-050A
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KPS
1999-11-10
E.CAM COMPUTER
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KPS
1999-10-29
MAPS 10000
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KPS
1999-10-07
EMORY CARDIAC TOOLBOX* 2.0 EXECUTING ON NUCLEAR MEDICINE COMPUTERS
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KPS
1999-10-07
BEACON-P, MODEL 211059
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KPS
1999-10-01
AUTOSPECT PLUS WITH INSTILL MOTION CORRECTION
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KPS
1999-09-01
VANTAGE EXSPECT II
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KPS
1999-08-26
HAWKEYE OPTION FOR DUAL-HEAD VARIABLE ANGLE GAMMA CAMERA
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KPS
1999-08-23
MG ATC: ATTENUATION CORRECTION SYSTEM FOR DUAL-HEAD VARIABLE-ANGLE GAMMA CAMERA
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KPS
1999-08-02
TAC-2, TRANSMISSION ATTENUATION CORRECTION AND DST, DST-XL GAMMA CAMERAS AND VISION POWER STATION COMPUTER, FOR USE IN S
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KPS
1999-07-30
CONVERGENCE CDR FOR HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERAS
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KPS
1999-07-26
VANTAGE 2.5
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KPS
1999-06-18
CONVERGENCE NUA FOR HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERAS
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KPS
1999-05-13
HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERA SYSTEM WITH THICK NAL(TI) CRYSTAL
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KPS
1999-04-16
BEACON, MODEL 211060
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KPS
1998-12-23
TRANSMISSION KIT, TRANS-CT, MODEL NSTR-050A
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