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
2022-12-02
JAK
2022-10-20
AI-Rad Companion (Musculoskeletal)
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JAK
2022-09-23
XACT Robotic System, ACE Model
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JAK
2022-09-12
Aquilion Precision (TSX-304A/4) V10.10 with AiCE
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JAK
2022-08-11
Medical image processing software
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JAK
2022-08-11
AI-Rad Companion (Pulmonary)
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JAK
2022-07-29
Deep Learning Image Reconstruction
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JAK
2022-07-13
syngo.CT Extended Functionality
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JAK
2022-07-12
NAEOTOM Alpha, Scan&GO Software
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JAK
2022-06-16
Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package, VSTP-001A
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JAK
2022-05-23
SCENARIA View
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JAK
2022-05-17
syngo.CT CaScoring
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JAK
2022-05-13
XACT ACE Robotic System
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JAK
2022-05-13
Spectral CT on Rails
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JAK
2022-05-06
NewTom 7G
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JAK
2022-05-02
Liver Suite
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JAK
2022-04-29
BodyTom 64
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JAK
2022-04-27
Philips Incisive CT
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JAK
2022-04-22
HealthOST
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JAK
2022-03-28
Syngo.CT Dual Energy
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JAK
2022-03-11
CardIQ Suite
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JAK
2022-03-07
syngo.CT Applications
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JAK
2022-02-25
OmniTom Elite
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JAK
2022-02-24
Epione
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JAK
2022-02-18
Deep Learning Image Reconstruction
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JAK
2022-02-04
Revolution Ascend
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JAK
2022-01-20
syngo.CT Extended Functionality
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JAK
2022-01-14
Respiratory Gating for Scanners v2.0
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JAK
2022-01-14
Precise Image
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JAK
2021-12-17
Revolution Apex, Revolution Apex Elite, Revolution Apex Plus, Revolution Apex Select,Revolution CT; Revolution CT ES; Revolution CT with Apex edition; Revolution CT ES with Apex edition
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JAK
2021-12-06
Al-Rad Companion (Pulmonary)
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JAK
2021-11-22
Philips Incisive CT on Trailer
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JAK
2021-09-30
NAEOTOM Alpha, Scan&GO
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JAK
2021-09-17
Deep Learning Image Reconstruction
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JAK
2021-09-15
HealthCCSng
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JAK
2021-09-10
Aquilion Exceed LB
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JAK
2021-09-02
Lung Image Analysis
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JAK
2021-08-27
SOMATOM go.Platform Scanners - SOMATOM go.Now, go.Up, go.All, go.Top, SOMATOM X. Platform Scanners - SOMATOM X.cite and SOMATOM X.ceed, Scan&GO Software
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JAK
2021-08-11
uCT ATLAS with uWS-CT-Dual Energy Analysis
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JAK
2021-07-22
syngo.CT Skull Unfolding
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JAK
2021-06-22
MICROMATE
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JAK
2021-06-17
Precise Position
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JAK
2021-04-30
syngo. CT Extended Functionalities
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JAK
2021-03-24
Aquilion ONE (TSX-306A/3) V10.4 with Spectral Imaging System
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JAK
2021-03-02
MaxFOV 2
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JAK
2021-02-26
Spectral CT
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JAK
2021-02-16
VesselIQ Xpress
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JAK
2021-02-02
CTxx85 CT Scanner
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JAK
2021-01-12
Aquilion Lightning (TSX-036A/7) V10.2 with AiCE-i
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JAK
2020-12-23
OmniTom Elite
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JAK
2020-12-10
Aquilion Exceed LB (TSX-202A/3) V10.6 with AiCE-I
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JAK
2020-12-10
Deep Learning Image Reconstruction for Gemstone Spectral Imaging
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JAK
2020-11-25
The Multimodality Advanced Vessel Analysis
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JAK
2020-11-20
Revolution Ascend
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JAK
2020-11-18
HiRise
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JAK
2020-11-12
FastStroke, CT Perfusion 4D
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JAK
2020-10-29
LSN
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JAK
2020-10-11
syngo.CT Neuro Perfusion
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JAK
2020-09-30
Clear Guide SCENERGY
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JAK
2020-08-07
VIDAvision
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JAK
2020-07-31
Clear Guide SCENERGY
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JAK
2020-07-22
SOMATOM On.site and On.scene
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JAK
2020-07-17
SCENARIA View
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JAK
2020-07-09
XACT Robotic System
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JAK
2020-07-06
Deep Recon
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JAK
2020-05-14
PercuNav Image Fusion and Interventional Navigation
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JAK
2020-05-14
Syngo.CT CaScoring
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JAK
2020-05-14
XV Lung Ventilation Analysis Software
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JAK
2020-04-01
SOMATOM X.cite, Scan&GO, SOMATOM go.Platform - go.Up, go.Now, go.Top, go.All, go. Sim, go. Open Pro, Scan&GO
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JAK
2020-03-25
syngo.CT Cardiac Planning
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JAK
2020-03-20
Hepatic VCAR
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JAK
2020-03-16
Al-Rad Companion (Musculoskeletal)
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JAK
2020-03-05
CURA 778
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JAK
2020-03-04
Broncholab
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JAK
2020-02-25
uCT 530, uCT 550
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JAK
2020-02-21
Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-i
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JAK
2020-02-13
Aquilion ONE (TSX-306A/3) V10.0 with Spectral Imaging System
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JAK
2020-01-24
IQon Spectral CT
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JAK
2020-01-16
Auto Positioning
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JAK
2019-12-17
syngo.CT CaScoring
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JAK
2019-12-13
Deep Learning Image Reconstruction
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JAK
2019-11-21
SOMATOM Go Platform – SOMATOM go.Now, go.Up, go.All, go.Top, go.Sim, go.Open Pro, Scan & GO
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JAK
2019-11-06
SOMATOM X.cite
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JAK
2019-10-24
Revolution Maxima, Revolution Ace
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JAK
2019-10-03
Ablation Confirmation
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JAK
2019-10-03
XACT Robotic System
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JAK
2019-09-20
syngo.CT Extended Functionality
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JAK
2019-09-13
SCENARIA View
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JAK
2019-09-10
AI-Rad Companion (Cardiovascular)
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JAK
2019-09-06
Aquilion ONE (TSX-306A/3) V10.0
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JAK
2019-08-07
ILLUMISITE Platform
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JAK
2019-07-29
Access CT
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JAK
2019-07-26
Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition
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JAK
2019-07-26
AI-Rad Companion (Pulmonary)
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JAK
2019-07-05
Aquilion Precision (TSX-304A/1 and /2) V8.8 with AiCE
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JAK
2019-07-03
syngo.CT Dual Energy
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JAK
2019-06-27
SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM Definition AS Open, SOMATOM Edge Plus, SOMATOM Definition AS/AS+, SOMATOM Confidence
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JAK
2019-06-12
Aquilion ONE (TSX-305A/6) V8.9 with AiCE
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JAK
2019-06-05
Low Dose Lung Screening Option
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JAK
2019-05-29
Brain Perfusion (BP) application
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