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
2013-02-08
JAK
2013-02-01
PLANMED VERITY
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JAK
2012-12-27
SYNGO SINGLE SOURCE DUAL ENGERY
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JAK
2012-12-21
SPIN DRIVE ALWAYS-ON TIP TRACKED STEERABLE CATHETER ALWAYS-ON TIP TRACKED SHEATH ALWAYS-ON TIP TRACKED ASPIRATION NEEDLE
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JAK
2012-12-20
SYNGO, CT CARDIAC FUNCTION
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JAK
2012-12-14
PERCUNAV
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JAK
2012-11-16
NEUVIZ 64 MULTI-SLICE CT SCANNER SYSTEM
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JAK
2012-10-26
SUPERDIMENSION NITINOL/GOLD FIDUCIAL MARKER
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JAK
2012-09-26
ITERATIVE RECONSTRUCTION TECHNIQUE SOFTWARE APPLICATION
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JAK
2012-09-21
AQUILION ONE VISION, V4.90
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JAK
2012-09-13
GSI VIEWER WITH VUE OPTION
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JAK
2012-09-11
SOMATOM DEFINITION
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JAK
2012-08-17
LUNG VOLUME ANALYSIS
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JAK
2012-07-26
AQUILION RXL
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JAK
2012-07-11
MINICAT
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JAK
2012-06-18
CARDIQ XPRESS 2.0 WITH SNAPSHOT FREEZE OPTION CARDIQ XPRESS 2.0 REVEAL
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JAK
2012-06-13
AQUILION PREMIUM
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JAK
2012-06-12
DISCOVERY CT750 HD
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JAK
2012-05-23
SOMATOM DEFINITION EDGE
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JAK
2012-05-23
SOMATOM PERSPECTIVE
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JAK
2012-05-08
SOMATOM DEFINITION FLASH
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JAK
2012-05-07
IPLAN (IPLAN CRANIAL, IPLAN STEREOTAXY, IPLAN ENT, IPLAN CMF, IPLAN VIEW, IPLAN SPINE)
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JAK
2012-05-03
GUIDESHOT OPTION, SCENARIA WHOLE-BODY X-RAY CT SYSTEM
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JAK
2012-04-13
SYNGO CT DYNAMIC ANGIO
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JAK
2012-04-13
CT-GUIDE NEEDLE GUIDANCE SYSTEM
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JAK
2012-04-10
PEDCAT
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JAK
2012-04-10
AQUILION ONE
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JAK
2012-04-10
AQUILION CXL
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JAK
2012-04-06
AQUILION PRIME
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JAK
2012-01-26
AQUILION PRIME
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JAK
2011-12-29
SOMATOM DEFINITION FLASH
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JAK
2011-11-22
SAFIRE
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JAK
2011-11-10
CT-GUIDE NEEDLE GUIDANCE SYSTEM
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JAK
2011-09-09
GE VEO RECONSTRUCTION OPTION
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JAK
2011-08-25
AQUILION LB MOVEMENT BASE KIT
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JAK
2011-08-18
SYNGO.CT VASCULAR ANALYSIS
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JAK
2011-07-20
OPTIMA CT660
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JAK
2011-06-21
CT-GUIDE NEEDLE GUIDANCE SYSTEM
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JAK
2011-04-19
DISCOVERY MODEL CT590 RT AND OPTIMA MODEL CT580 CT SYSTEMS
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JAK
2011-04-12
SYNGO.CT CARDIAC FUNCTION
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JAK
2011-04-08
SCENARIA WHOLE-BODY X-RAY CT SYSTEM
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JAK
2011-03-24
BODYTOM NL 4000
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JAK
2011-03-11
COMPUTED TOMOGRAPHY X-RAY SYSTEM
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JAK
2011-03-04
SOMATOM DEFINITION AS
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JAK
2011-02-18
DENTAL COMPUTED TOMOGRAPHY X-RAY SYSTEM
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JAK
2011-02-11
SUPERDIMENSION MARKER DELIVERY KIT
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JAK
2010-11-18
AQUILION ONE VERSION 4.6 W/DUAL ENERGY SCAN SYSTEM, MODEL TSX-301A/2
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JAK
2010-10-07
I-LOGIC INREACH SYSTEM
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JAK
2010-08-04
ICAD VERALOOK CTC CAD SOFTWARE
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JAK
2010-06-18
BF-NAVI
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JAK
2010-05-26
SYNGO.CT CORONARY ANALYSIS
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JAK
2010-03-11
IGUIDE CAPPA
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JAK
2010-01-27
IG 4 IMAGE GUIDED SYSTEM
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JAK
2009-12-02
IG4 ENDOBRONCHIAL, MODEL SYS-0200, NAVIGATION GUIDEWIRE (ACCESSORY TO IG4 ENDOBRONCHIAL), MODEL INS-0300
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JAK
2009-11-30
IG4 IMAGE GUIDED SYSTEM, MODEL: SYS-0200
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JAK
2009-10-09
PHILIPS COMPREHENSIVE CARDIAC ANALYSIS (CCA) - PLAQUE ASSESSMENT TOOL
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JAK
2009-10-09
COMPUTED TOMOGRAPHY X-RAY SYSTEM, MODEL PICASSO-DUO
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JAK
2009-09-22
NEUVIZ 16 MULTI-SLICE CT SCANNER SYSTEM
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JAK
2009-09-04
INREACH SYSTEM, MODEL AAS00161-02
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JAK
2009-07-17
SYNGO VOLUME PERFUSION-CT BODY
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JAK
2009-06-24
GE LIGHTSPEED ACT FP16
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JAK
2009-06-23
BRILLIANCE DUAL ENERGY OPTION
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JAK
2009-06-15
GUIDESHOT OPTION FOR CXR4 AND ECLOS CT SYSTEMS
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JAK
2009-05-27
PHILIPS MX 16 SLICE CT SYSTEM PHASE11, MODEL 9896 056 56511
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JAK
2009-04-01
SYNGO DUAL ENERGY WITH EXTENDED FUNATIONALLY
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JAK
2009-03-05
CSBP-001A BODY PERFUSION SYSTEM
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JAK
2009-02-11
COLON VIEW, MODEL CSCV-001A
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JAK
2009-02-05
NEUVIZ 16 MULTI-SLICE CT SCANNER SYSTEM
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JAK
2008-12-17
PHILIPS MODEL MX 16 SLICE CT SYSTEM
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JAK
2008-12-12
MODEL TSX-301B AQUILION CT SYSTEM
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JAK
2008-12-05
VIATRONIX V3D-CARDIAC, REVISION 1.0
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JAK
2008-11-18
VIDA PULMONARY WORKSTATION 2 (PW2)
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JAK
2008-10-17
GE XTREME INJECTOR OPTION
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JAK
2008-10-17
P3T ABDOMEN
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JAK
2008-10-16
VB IMAGE VIEWER
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JAK
2008-10-10
SOMATOM FLASH DS
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JAK
2008-10-08
GE BRIGHTSPEED DELIGHT CT SCANNER SYSTEM
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JAK
2008-10-08
GE LIGHTSPEED 7.2 CT SCANNER SYSTEM
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JAK
2008-09-02
GE LIGHTSPEED RT16 / LIGHTSPEED XTRA V2 CT SYSTEM (AKA GE LIGHTSPEED RT16 / LIGHTSPEED XTRA CT SYSTEM
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JAK
2008-08-21
PICASSO MASTER, ECT AND MASTER 3D
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JAK
2008-06-11
CSBP-001A BODY ORGAN PERFUSION SYSTEM
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JAK
2008-06-11
MODIFICATION TO INREACH SYSTEM
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JAK
2008-06-02
SOMATOM DEFINITION, MODEL AS/AS+
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JAK
2008-05-09
GE LIGHTSPEED CT750 HD (LIGHTSPEED 8.0)
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JAK
2008-04-11
NAVSTATIONIRAD EMT, VERSION 1.1
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JAK
2008-04-09
3D ACCU-I-TOMO XYZ SLICE VIEW TOMOGRAPH, MODEL MCT-1F8/F17
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JAK
2008-03-31
INREACH SYSTEM
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JAK
2008-03-21
ZIEHM VISION 2
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JAK
2008-03-14
MODEL TSX-101A/H/I AQUILION 32/64 SP CT SYSTEM
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JAK
2008-03-13
NEUSOFT SPIRAL CT SCANNER SYSTEM, MODEL NEUVIZ VERSION 2.0
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JAK
2008-02-26
CARDIQ FUNCTION XPRESS
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JAK
2008-02-26
CARDIQ EXPRESS VERSION 2.0
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JAK
2008-02-07
SYNGO DUAL ENERGY WITH EXTENDED FUNCTIONALLY
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JAK
2008-01-03
SYNGO VOLUME PERFUSION-CT NEURO
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JAK
2007-12-18
SYNGO VOLUME PERFUSION-CT BODY
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JAK
2007-11-01
CSNP-001A NEURO PACKAGE
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JAK
2007-10-18
ALPHARD CONE BEAM CT, MODEL X178
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JAK
2007-10-16
NEUVIZ SPIRAL CT SCANNER SYSTEM
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JAK
2007-10-05
CSCS-001A CALCIUM SCORING PACKAGE
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JAK
2007-10-02
AQUILION ONE TSX-301A/2 COMPUTED TOMOGRAPHY SYSTEM
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