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
2019-04-15
JAK
2019-04-12
Deep Learning Image Reconstruction
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JAK
2019-04-08
Bone VCAR (BVCAR)
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JAK
2019-03-08
NewTom 5G XL
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JAK
2019-02-13
SnapShot Freeze 2
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JAK
2019-02-01
Supria True64 Whole-Body X-Ray CT System
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JAK
2019-01-03
uCT 520, uCT 528
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JAK
2018-11-16
Celesteion, PCA-9000A/3, V6.5
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JAK
2018-10-04
CURA 16; ScintCare CT16
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JAK
2018-09-14
Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034A
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JAK
2018-09-07
CTXX85
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JAK
2018-08-14
uCT 530, uCT 550
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JAK
2018-08-03
Philips CT Big Bore Sliding Gantry Configuration
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JAK
2018-06-13
HealthCCS
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JAK
2018-06-05
LungQ Software
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JAK
2018-05-16
Low Dose CT Lung Cancer Screening Option
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JAK
2018-05-11
LineUp
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JAK
2018-04-24
GSI Viewer with GSI Fat Option
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JAK
2018-04-24
IMACTIS CT-Navigation system
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JAK
2018-04-13
SOMATOM go.Up, SOMATOM go.Now, SOMATOM go.Top, SOMATOM go.All, Scan&GO
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JAK
2018-03-30
syngo.CT Coronary Analysis; syngo.CT Vascular Analysis
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JAK
2018-03-30
SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM Definition AS Open, SOMATOM Deinition AS/AS+, SOMATOM Confidence
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JAK
2018-03-21
SOMATOM Edge Plus
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JAK
2018-03-20
Philips Incisive CT
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JAK
2018-03-15
AIRO Computed Tomography (CT) X-ray System
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JAK
2018-03-08
syngo.CT Clinical Extensions
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JAK
2018-03-02
uCT Computed Tomography X-ray System
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JAK
2018-02-23
Aquilion Precision (TSX-304A/2) V8.6 with FIRST 3.0
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JAK
2018-02-13
CT6485, CT12885
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JAK
2018-02-08
superDimension Navigation System V7.2
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JAK
2018-01-19
OnSight 3D Extremity System
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JAK
2017-12-08
Clear Guide SCENERGY
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JAK
2017-12-07
NeuViz 16 Essence Multi-slice CT Scanner System
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JAK
2017-11-22
CereTom Elite
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JAK
2017-11-16
SIRIO H3
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JAK
2017-11-09
Philips CT Big Bore
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JAK
2017-10-06
Aquilion Prime SP, TSX-303B/1, v8.4
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JAK
2017-09-13
NeuViz Prime Multi-slice CT Scanner System
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JAK
2017-08-18
Supria True64
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JAK
2017-08-18
ScannerSide DoseCheck
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JAK
2017-08-18
OmniTom
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JAK
2017-06-30
Aquilion ONE (TSX-305A/3) V8.3 with FIRST 2.1
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JAK
2017-06-14
BodyTom Elite
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JAK
2017-06-05
Revolution ACT
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JAK
2017-05-15
SPiN Thoracic Navigation System
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JAK
2017-05-09
Ablation Confirmation
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JAK
2017-05-05
In Reach
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JAK
2017-04-28
Z-DOSE29
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JAK
2017-04-21
PercuNav Image Fusion and Interventional Navigation
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JAK
2017-04-21
syngo.CT Cardiac Planning
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JAK
2017-04-07
Philips iCT CT System
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JAK
2017-04-05
IQon Spectral CT
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JAK
2017-03-24
Scan&GO
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JAK
2017-03-21
SOMATOM go.Up, SOMATOM go.Now
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JAK
2017-03-03
HITACHI Supria Whole-body X-ray CT System Phase 3
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JAK
2017-03-01
syngo. CT Neuro Perfusion
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JAK
2017-02-09
syngo.CT Extended Functionality
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JAK
2017-02-09
syngo. CT Single Source Dual Energy (twin beam)
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JAK
2017-02-02
Aquilion Lightning, TSX-036A/1, V8.4
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JAK
2017-01-26
FastStroke
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JAK
2016-12-16
Revolution CT
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JAK
2016-12-16
Somatom Confidence ® RT Pro
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JAK
2016-11-03
Vitrea CT Dual Energy Image View
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JAK
2016-08-30
OnSight 3D Extremity System
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JAK
2016-08-24
SOMATOM Drive
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JAK
2016-08-17
SUPRIA w/guideShot Option
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JAK
2016-08-10
SpotLight CT
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JAK
2016-08-08
Philips Ingenuity CT
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JAK
2016-08-08
P-ARTIS
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JAK
2016-07-22
Aquilion ONE Vision with FIRST 2.0 (CCRS-001B) V7.4
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JAK
2016-06-29
Ablation Confirmation
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JAK
2016-06-29
ADMIRE
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JAK
2016-06-16
ECG CT Gating Device
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JAK
2016-06-09
Aquilion ONE (TSX-305A/3) V7.3
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JAK
2016-05-17
SafeCT-29
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JAK
2016-04-19
AIRO Computed Tomography (CT) X-ray System
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JAK
2016-04-08
Philips Multislice CT System with Low Dose CT Lung Cancer
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JAK
2016-04-01
Aquilion Lightning, TSX-035A/4 and /5, V7.0
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JAK
2016-03-25
SOMATOM Perspective
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JAK
2016-03-18
somatom Scope(with syngo CT VC30-easyIQ version), SOMATOM Scope Power(with syngo CT VC30-easyIQ version)
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JAK
2016-03-09
SmartView 3D Option
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JAK
2016-02-19
syngo.CT Single Source Dual Energy (Twin Beam)
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JAK
2016-02-12
Clear Guide SCENERGY
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JAK
2016-01-20
Stroke VCAR
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JAK
2016-01-20
CAS-One IR
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JAK
2013-12-12
MYOPERFUSION
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JAK
2013-11-07
AQUILION ONE VISION, V6.0
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JAK
2013-09-26
AIRO CT SYSTEM
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JAK
2013-09-24
BRILLIANCE ICT
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JAK
2013-08-30
OPTIMA CT660
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JAK
2013-08-29
SYNGO CT PULMO 3D
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JAK
2013-08-20
SURESUBTRACTION ORTHO
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JAK
2013-07-24
PERCUNAV SYSTEM
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JAK
2013-07-18
ICT
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JAK
2013-06-07
IMR SOFTWARE APPLICATION
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JAK
2013-06-06
AQUILION PRIME, V5.00
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JAK
2013-05-02
AQUILION LB TRITON V4.91
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JAK
2013-04-02
SYNGO.CT NEURO PERFUSION
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JAK
2013-03-29
SCENARIA PHASE 2 WHOLE-BODY X-RAY CT SYSTEM
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JAK
2013-03-12
SYNGO, CT BONE READING
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