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
2026-09-22
JAK
2026-09-18
SCENARIA View Phase 6.0
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JAK
2026-09-04
FCT iStream Phase 2
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JAK
2026-07-28
BodyTom Elite (NL4000)
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JAK
2026-07-21
CardIQ Suite
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JAK
2026-06-24
Enhanced Boundary for PCCT
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JAK
2026-06-04
Respiratory Gating for Scanners (2.1)
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JAK
2026-05-20
Aquilion ONE (TSX-308A/TSX-306A) V2.0
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JAK
2026-03-27
Spectral CT Verida Family
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JAK
2026-03-23
True Definition DL
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JAK
2026-03-23
CT Rembra RT; CT Areta RT; CT Rembra
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JAK
2026-03-20
SOMATOM X.cite; SOMATOM X.ceed
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JAK
2026-03-20
Photonova Spectra, Photonova Spectra Select
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JAK
2026-03-13
Aquilion ServeSP (TSX-307B) V2.0
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JAK
2026-03-13
Extremity CT Imaging System
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JAK
2026-03-06
Bunkerhill Contrast AVC
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JAK
2026-03-06
Bunkerhill Contrast CAC
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JAK
2026-03-05
AV Cardiac CT
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JAK
2026-01-20
uCT 780 with uWS-CT-Dual Energy Analysis
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JAK
2025-11-28
CT VScore+
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JAK
2025-10-15
syngo.CT Dual Energy
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JAK
2025-10-03
Bunkerhill MAC
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JAK
2025-10-02
LungQ 4
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JAK
2025-09-26
Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6 with Calculated DAP
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JAK
2025-09-08
OmniTom Elite with PCD
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JAK
2025-08-28
CT:VQ
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JAK
2025-08-01
Revolution Vibe
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JAK
2025-07-28
NAEOTOM Alpha.Peak/NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime
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JAK
2025-07-25
Marie
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JAK
2025-07-03
SOMATOM go.Now; SOMATOM go.Up; SOMATOM go.All; SOMATOM go.Top; SOMATOM go.Sim; SOMATOM go.Open Pro; SOMATOM Pro.Pulse
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JAK
2025-06-27
Philips iCT CT system
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JAK
2025-06-20
CT Scanner TSX-501R/1 V11.1
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JAK
2025-06-18
CardIQ Suite
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JAK
2025-05-20
SCENARIA View Phase 5.0
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JAK
2025-05-16
Spectral CT
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JAK
2025-05-16
uCT ATLAS Astound with uWS-CT-Dual Energy Analysis; uCT ATLAS with uWS-CT-Dual Energy Analysis
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JAK
2025-04-15
SpotLight / SpotLight Duo with Low Dose Lung Cancer Screening Option
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JAK
2025-04-10
Vitrea CT VScore
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JAK
2025-03-14
BodyTom 64
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JAK
2025-02-19
Brainomix 360 e-Lung
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JAK
2025-02-12
NAEOTOM Alpha.Peak/ NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime
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JAK
2025-01-27
Bunkerhill AVC
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JAK
2025-01-14
uCT 550
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JAK
2025-01-13
SpotLight/SpotLight Duo with Low Dose Lung Cancer Screening Option
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JAK
2025-01-07
uCT 780
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JAK
2025-01-03
syngo.CT Dual Energy
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JAK
2024-12-23
Aquilion ONE (TSX-308A/3) V1.5
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JAK
2024-12-03
ClearRead CT CAC
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JAK
2024-11-21
Gating Reflector Block
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JAK
2024-10-18
Spectral CT 7500 RT
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JAK
2024-09-27
CAC (gated) Algorithm
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JAK
2024-09-03
SOMATOM On.site
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JAK
2024-08-19
HealthCCSng
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JAK
2024-08-01
CardIQ Suite
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JAK
2024-07-12
HiRise (1040-230)
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JAK
2024-06-10
OmniTom Elite
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JAK
2024-05-13
Brainomix 360 e-Lung
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JAK
2024-05-03
CT 5300
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JAK
2024-04-26
FCT iSTREAM Phase 1
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JAK
2024-04-11
True Enhance DL
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JAK
2024-04-04
ABLATE-IQ
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JAK
2024-04-02
ECG-less Cardiac
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JAK
2024-04-02
Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction System
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JAK
2024-03-28
NAEOTOM Alpha
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JAK
2024-03-26
SOMATOM go.Up; SOMATOM go.Now; SOMATOM go.All; SOMATOM go.Top; SOMATOM go.Sim; SOMATOM go.Open Pro; SOMATOM X.cite; SOMATOM X.ceed
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JAK
2024-03-21
AI-Rad Companion (Pulmonary)
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JAK
2024-03-13
CAS-One IR
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JAK
2024-02-22
Revolution Ascend Sliding
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JAK
2024-02-08
HealthFLD
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JAK
2024-01-17
Clear Guide SCENERGY
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JAK
2024-01-08
LungQ v3.0.0
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JAK
2024-01-04
syngo.CT Applications
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JAK
2023-12-06
Aquilion Serve SP (TSX-307B/1) V1.3
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JAK
2023-12-06
SOMATOM Pro.Pulse
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JAK
2023-11-30
syngo.CT Dual Energy
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JAK
2023-11-29
uCT ATLAS Astound with uWS-CT-Dual Energy Analysis, uCT ATLAS with uWS-CT-Dual Energy Analysis
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JAK
2023-11-28
BriefCase-Quantification
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JAK
2023-11-16
CT Lung Ventilation Analysis Software (CT:V)
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JAK
2023-10-27
MeVis Liver Suite
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JAK
2023-10-13
SpotLight/SpotLight Duo (with DLIR option)
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JAK
2023-10-12
Scenaria View 4.2
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JAK
2023-10-11
NeuViz 128 Multi-Slice CT Scanner System
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JAK
2023-10-10
Micromate™ Navi+
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JAK
2023-09-19
Aquilion Serve (TSX-307A/1) V1.3
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JAK
2023-08-01
uCT 760 with uWS-CT-Dual Energy Analysis, uCT 780 with uWS-CT-Dual Energy Analysis
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JAK
2023-07-13
Spine Auto Views
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JAK
2023-07-13
Open Rib
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JAK
2023-06-16
SOMATOM Edge Plus, SOMATOM Confidence, SOMATOM Definition Edge, SOMATOM Definition AS/AS+, SOMATOM Definition AS Open, SOMATOM Drive, SOMATOM Force, SOMATOM Definition Flash
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JAK
2023-06-13
CAC Software
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JAK
2023-06-01
OmniTom Elite
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JAK
2023-05-03
Epione
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JAK
2023-04-25
iCAC Device
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JAK
2023-04-20
Deep Learning Image Reconstruction
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JAK
2023-04-06
AI-Rad Companion (Cardiovascular)
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JAK
2023-03-09
Spectral Bone Marrow
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JAK
2023-03-07
Aquilion Precision (TSX-304A/4) V10.14 with AiCE
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JAK
2023-03-03
Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i
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JAK
2023-02-16
uCT ATLAS Astound with uWS-CT-Dual Energy Analysis
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JAK
2023-01-18
PercuNav Image Fusion and Interventional Navigation System
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JAK
2022-12-22
Philips CT 3500
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