System, X-Ray, Tomography, Computed
FDA product code JAK · 765 cleared devices
Class 2
Radiology
- Regulation
- 21 CFR 892.1750
- Review panel
- RA
- Implant
- No
- Life sustaining
- No
- Third party review
- Yes
- GMP exempt
- No
- Clearance span
- 1976-10-05 – 2026-09-22
JAK
1996-02-09
JAK
1996-01-30
PQ-2000+ COMPUTED TOMOGRAPHY X-RAY SYSTEM
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JAK
1996-01-26
SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-7000TC
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JAK
1996-01-26
SHIMADZU WHOLE BODY X-RAY SCANNER SCT-7000TH
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JAK
1995-10-19
DPX TISSUE QUANTIFICATION OUTPUT
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JAK
1995-10-07
PHILIPS TOMOSCAN SR 8000
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JAK
1995-04-27
PQ5000 CT SYSTEM
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JAK
1995-03-14
HRSW OPTION FOR CT TWIN FLASH
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JAK
1995-02-07
CT PROSPEED FAMILY
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JAK
1995-01-25
ANATOM 2000
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JAK
1994-11-29
MEDRAD COUNTERPOISE SYSTEM
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JAK
1994-10-21
PHILIPS TOMOSCAN SR5000
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JAK
1994-10-11
PHILIPS TOMOSCAN SR 4000
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JAK
1994-09-20
SOMATOM PROJECT 059
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JAK
1994-08-23
HISPEED ADVANTAGE II
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JAK
1994-07-29
TSX-002A (XVISION) CT SCANNER
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JAK
1994-07-29
ANGIOCT OPTION FOR CT-TWIN, HELICAT & OMNIVIEW
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JAK
1994-07-05
MRX-280
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JAK
1994-07-05
SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-4800TF
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JAK
1994-05-17
VOLUMETRIC RENDERING TECHNIQUE OPTION
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JAK
1994-04-07
COMPUTERIZED TOMOGRAPHY X-RAY SYSTEM OPTION
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JAK
1994-03-22
SIMULIX-MC CT EXTENSION
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JAK
1993-12-14
IMPAX 3000
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JAK
1993-09-13
ULTRA COMPACT VIDEO IMAGER
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JAK
1993-03-19
HELICAT
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JAK
1993-03-10
PHILIPS TOMOSCAN SR7000 CT SYSTEMS
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JAK
1993-02-02
ADVANTAGE WINDOWS 3D OPTION AND DENTASCAN OPTION
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JAK
1993-01-15
SIM/PLANT
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JAK
1992-10-20
CT SYTEC 6000 COMPUTED TOMOGRAPHY SYSTEM
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JAK
1992-09-23
HEAD RESTRAINT FOR CT TABLES
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JAK
1992-09-23
ARM EXTENDER FOR CT TABLES
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JAK
1992-09-23
SCAN BAND
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JAK
1992-09-23
ADULT CHIN STRAP FOR CT TABLES
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JAK
1992-09-23
WRIST RESTRAINT FOR GE9800 C.T. TABLES
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JAK
1992-09-11
SCAN BAND
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JAK
1992-07-21
EXCEL CT TWIN
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JAK
1992-05-28
SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-4500TF
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JAK
1992-02-27
SYTEC DENTASCAN
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JAK
1992-02-14
SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-4500TE
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JAK
1992-01-23
CT SYTEC 8000
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JAK
1991-11-29
C-150 ULTRAFAST CT SCANNER
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JAK
1991-11-22
COMPUTERIZED TOMOGRAPHY X-RAY SYSTEM OPTION
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JAK
1991-10-15
GYROVIEW-HR
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JAK
1991-09-27
KODAK EKTASCAN XLP PRELIMINARY DV2000 INTERFACE
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JAK
1991-09-23
IMAC2000
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JAK
1991-09-06
VORTECH'S PERSONAL DISPLAY SYSTEM
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JAK
1991-09-06
PHILIPS TOMOSCAN SR
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JAK
1991-08-26
LITEBOX
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JAK
1991-07-17
SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-5000TX
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JAK
1991-07-17
SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-5000TH
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JAK
1991-05-17
COMPUTERIZED TOMOGRAPHY X-RAY SYSTEM
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JAK
1991-05-09
CT SYTEC 4000
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JAK
1991-03-15
HELICAL SCAN
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JAK
1991-01-14
CT HILIGHT ADVANTAGE II
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JAK
1990-11-07
XPRESS
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JAK
1990-11-02
COMPUTED TOMOGRAPHY X-RAY SYSTEM
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JAK
1990-10-29
CT GUIDE (TM)
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JAK
1990-08-17
XPEED COMPUTED TOMOGRAPHY X-RAY SYSTEM
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JAK
1990-08-01
FASTRECON 88 PERIFERAL
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JAK
1990-07-25
MODIFIED EXEL 2400 ELITE/U & EXEL 2400E/U
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JAK
1990-07-09
FALCON DISK DRIVE SUBSYSTEM
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JAK
1990-03-13
TOMOSCAN STEREOTAXIS SIMULATION SOFTWARE
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JAK
1990-03-08
TCT-500S COMPUTED TOMOGRAPHY X-RAY SYSTEM
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JAK
1990-02-26
TCT-300S - UPGRADE
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JAK
1990-01-23
SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-3000TE
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JAK
1989-12-14
SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-3000TF
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JAK
1989-09-07
ELSCINT'S EXEL 2400E CT SCANNER
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JAK
1989-09-01
CT HILIGHT ADVANTAGE
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JAK
1989-08-07
CT SYTEC 3000
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JAK
1989-05-18
QCT-LUNG NODULE (TM) ANALYSIS PACKAGE
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JAK
1989-02-27
TOSHIBA TCT-600XT COMPUTED TOMOGRAPHY X-RAY SYSTEM
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JAK
1989-02-27
TCT-600HQ COMPU TOMO(CT)XRAY/HEAD/WHOLE BODY EXAM
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JAK
1989-02-09
3D/DENTAL
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JAK
1989-01-18
EXEL 2400 AND 2400 ELITE CT SCANNERS
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JAK
1989-01-18
EXEL 1800 AND 1800E CT SCANNER
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JAK
1988-12-30
EXEL 2002 & 2002FS CT SCANNER
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JAK
1988-12-30
EXEL 1002 CT SCANNER
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JAK
1988-12-30
EXEL 905 SERIES CT SCANNER
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JAK
1988-12-20
VOXELSCOPE(TM)
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JAK
1988-10-19
TCT-300S COMPUTED TOMO. (CT) X-RAY SYSTEM FOR EXAM
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JAK
1988-10-11
P-7 COMPUTED TOMOGRAPHY SYSTEM
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JAK
1988-09-02
SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-3000TC
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JAK
1988-08-19
DENTASCAN
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JAK
1988-08-15
CT MAX 640 #B7940 JA/JE
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JAK
1988-08-15
TOMOSCAN LX COMPUTED TOMOGRAPHY SYSTEM
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JAK
1988-07-26
XENON CT
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JAK
1988-05-18
SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-3000TX
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JAK
1988-03-28
SOMATOM PLUS
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JAK
1988-03-28
PICS-2000
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JAK
1988-02-25
SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-2000T-11
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JAK
1987-09-23
IMATRON C-100 ULTRAFAST CT SCANNER
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JAK
1987-09-23
CT PACE CATALOG NUMBER B7950A
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JAK
1987-08-12
I.S.G. 3DMV WORKSTATION
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JAK
1987-08-12
CT9800 QUICK 3D #B7919DA
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JAK
1987-05-08
CSI/3D
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JAK
1986-12-02
TOSHIBA TCT-600 COMPUTED TOMOGRAPHY (CT) X-RAY
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JAK
1986-11-10
C-IOO MOBILE CINE CT UNIT
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JAK
1986-10-07
CT MAX, CATALOG NO. B7940 HA
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JAK
1986-10-03
VISISCAN CT SCANNERS - MODELS V600, V1200 & V2400
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JAK
1986-08-29
SOLID STATE DETECTOR COMPUTERIZED TOMOGRAPHIC
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