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
2007-08-28
JAK
2007-08-16
MODIFICATION TO NEUVIZ DUAL MULTI-SLICE CT SCANNER SYSTEM
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JAK
2007-06-26
INSPACE 4D SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY
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JAK
2007-06-13
MODIFICATION TO EMPOWER CT/CTA INJECTOR SYSTEM, MODELS 9800/9900 PRODUCT SERIES
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JAK
2007-06-08
SYNGO CT ONCOLOGY SOFTWARE PACKAGE
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JAK
2007-04-05
DENTAL DIGITAL PANORAMIC/3D IMAGING SYSTEM
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JAK
2007-03-23
PET VCAR
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JAK
2007-01-05
SYNGO CIRCULATION SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY
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JAK
2006-11-30
SYNGO NEURO PBV CT
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JAK
2006-11-09
CSTC-002A, EXTENDED FIELD OF VIEW SOFTWARE OPTION
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JAK
2006-11-03
TSX-301A, AQUILION ONE CT SYSTEM
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JAK
2006-11-03
MODEL CVV-001A VESSEL VIEW SOFTWARE OPTION
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JAK
2006-11-02
EMPOWER CT/CTA INJECTOR SYSTEM, MODEL 9800/9900
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JAK
2006-10-05
QANGIO CT
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JAK
2006-10-05
SYNGO DUAL ENERGY
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JAK
2006-09-28
NEUVIZ DUAL MULTI-SLICE CT SCANNER SYSTEM
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JAK
2006-09-22
MODIFICATION TO SYNGO INSPACE 4D
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JAK
2006-09-08
SUPERDIMENSION/BRONCHUS PREMIUM 2
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JAK
2006-08-07
XCAT; XCAT FOR NEURO
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JAK
2006-07-25
SYNGO EXPERT-1
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JAK
2006-07-12
LIGHTSPEED 7.1 CT SCANNER SYSTEM
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JAK
2006-07-07
ZIEHM VARIO 3D DIGITAL MOBILE IMAGING SYSTEM
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JAK
2006-06-26
AUTOBONE2
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JAK
2006-06-05
BRILLIANCE VOLUME
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JAK
2006-05-30
CARDIQ FUSION
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JAK
2006-05-12
TSX-201A, AQUILION LB CT SCANNER WITH RESPIRATORY GATING
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JAK
2006-05-11
IG4 IMAGE GUIDED SYSTEM
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JAK
2006-04-19
GE LIGHTSPEED XTRA CT SCANNER SYSTEM
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JAK
2006-04-19
ABARIS
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JAK
2006-04-05
ADVANCE VESSEL ANALYSIS II
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JAK
2006-03-10
CT PERFUSION 4
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JAK
2006-02-17
CXR16
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JAK
2006-01-06
MAYFIELD SCANMATE MOBILE CT SYSTEM
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JAK
2005-12-27
3D ACCU-I-TOMO XYZ SLICE VIEW TOMOGRAPH, MODEL MCT-1 EXF
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JAK
2005-11-14
SUPERDIMENSION/BRONCHUS PREMIUM
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JAK
2005-11-08
ILUMA ORTHOCAT/DENTALCAT
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JAK
2005-11-04
SYNGO NEURO DSA CT
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JAK
2005-10-28
STARSPEED SERIES CT SCANNER SYSTEMS
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JAK
2005-09-21
SYNERAD IMPACT 60, SYNERAD IMPACT 72 AND ANALOGIC AMS1600
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JAK
2005-09-08
SUPERDIMENSION/BRONCHUS 4.1
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JAK
2005-09-08
SOMATOM DEFINITION
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JAK
2005-08-25
INNOVA CT OPTION FOR DIGITAL FLUOROSCOPIC IMAGING SYSTEMS INNOVA MODELS 4100, 4100IQ, 3100, 3100IQ & 2100IQ
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JAK
2005-08-19
DVT SCANNER
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JAK
2005-08-09
SYNGO CIRCULATION
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JAK
2005-07-15
TSX-101A/H AQUILION 64 SP CT SCANNER; TSX-101A/I AQUILION 32 SP CT SCANNER
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JAK
2005-07-14
CERETOM, MODEL NL3000
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JAK
2005-04-14
SYNGO BODY PERFUSION-CT
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JAK
2005-03-10
TSX-201A AQUILION LB CT SCANNER
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JAK
2005-03-01
SOMATOM EMOTION 16
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JAK
2005-02-03
SYNGO INSPACE 4D
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JAK
2004-12-23
SOMATOM RESPIRATORY GATING
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JAK
2004-12-15
SOMATOM CARE CONTRAST CT
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JAK
2004-11-18
PLAQUEVIEW SOFTWARE, MODEL CSPV-0001A
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JAK
2004-11-08
SUPERDIMENSION/BRONCHUS
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JAK
2004-09-14
SOMATOM SPIRIT
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JAK
2004-09-08
BRILLIANCE CT, PRIVATE PRACTICE CV CONFIGURATION, CT SCANNER
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JAK
2004-09-01
SOMATOM RADIATION TREATMENT PLANNING (RTP) PACKAGE
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JAK
2004-07-13
N-VIVO CALCIUM SCORE ON IA CHASSIS RELEASE, MODEL RELEASE X.XX
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JAK
2004-06-22
VOLUME VIEWER PLUS
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JAK
2004-06-17
CT-C3000DUAL AND CT-C2800DUAL FAMILY OF DUAL-SLICE CT SCANNER SYSTEMS
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JAK
2004-05-27
CARDIQ ANALYSIS III
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JAK
2004-04-21
HITACHI PRESTO
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JAK
2004-04-06
CADIMPLANT
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JAK
2004-04-02
SOMATOM SENSATION 64 AND SENSATION CARDIAC
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JAK
2004-03-22
SOMATOM PROJECT P30L
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JAK
2004-03-02
CT-MASS
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JAK
2004-03-01
LIGHTSPEED 7.0 CT SCANNER SYSTEM
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JAK
2004-02-20
BRAIN PERFUSION OPTION
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JAK
2004-01-09
ACQSIM-MULTISLICE-CT, MODEL 453567042271
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JAK
2003-12-23
SYNGO PERFUSION-CT
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JAK
2003-11-20
LIGHTSPEED 6.0 CT SCANNER SYSTEM
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JAK
2003-11-10
TSX-101A/A AND TSX-101A/C AQUILION MULTISLICE CT SCANNERS
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JAK
2003-11-10
MEDICHEART, MODEL RELEASE 1
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JAK
2003-11-10
SOMATOM EXTENDED FIELD OF VIEW SOFTWARE OPTION
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JAK
2003-11-10
SOMATON COMPUTED TOMOGRAPHY X-RAY SYSTEMS SLIDING GANTRY OPTION
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JAK
2003-11-05
MEDIC COLON MODEL, RELEASE 1
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JAK
2003-10-30
ADVANTAGE 4D OPTION
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JAK
2003-10-29
PHILIPS PLUS COMPUTED TOMOGRAPHY SYSTEM
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JAK
2003-10-02
MINICAT DENTOCAT
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JAK
2003-06-20
AUTOBONE
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JAK
2003-05-22
AQUILION SUPER 4 MULTISLICE CT SCANNER, MODEL TSX-101A/7
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JAK
2003-05-21
RADIOMED SOFT TISSUE MARKER
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JAK
2003-05-06
CARD EP
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JAK
2003-05-06
3D ACCU-I-TOMO XYZ SLICE VIEW TOMOGRAPH
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JAK
2003-05-06
CT COLONOGRAPHY
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JAK
2003-03-10
LIGHTSPEED 5.0 COMPUTED TOMOGRAPHY SYSTEM
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JAK
2003-03-04
VIDAR BONE TRACK SYSTEM SOFTWARE
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JAK
2003-02-21
PRIMELUNG
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JAK
2003-02-10
LUNG NODULE ASSESSMENT AND COMPARISON OPTION
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JAK
2003-01-31
RADIOMED MARKER
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JAK
2002-11-22
CT CARDIAC FUNCTION ANALYSIS SOFTWARE, MODELS CSCF-001A AND CSCF-001B
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JAK
2002-11-22
SOMATOM EMOTION 6 CT SYSTEMS
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JAK
2002-10-23
LIGHTSPEED ULTRA COMPUTED TOMOGRAPHY SYSTEM WITH WIDE-VIEW
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JAK
2002-10-11
E-SPEED EBT SCANNER SYSTEM
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JAK
2002-09-19
SMART BREATH RESPIRATORY COMPENSATION OPTION
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JAK
2002-08-23
SURGETICS ENTACT ENDONASAL NAVIGATION SYSTEM
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JAK
2002-08-13
ULTRAGUIDE CTG 2000SA
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JAK
2002-08-06
LODOX, MODEL BASELINE
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JAK
2002-07-16
LUNGCARE CT SOFTWARE PACKAGE
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JAK
2002-07-09
CGS-31A MULTISLICE UPGRADE KIT FOR AQUILION CT SCANNER. TSX-101A (AQUILION ADVANCE MULTI)
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