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Panels › Radiology › Product code JAK · Class 2

System, X-Ray, Tomography, Computed

Regulation 892.1750

22510(k)s in 12 months (827 all time)
38recalls in 12 months (872 all time)
795recalls that name a 510(k)
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Top companies in JAK

Company510(k)sRecalls
Philips Medical Systems (Cleveland), Inc.24282
Siemens AG Medical Solutions117162
GE Healthcare796
GE Medical Systems6829
Philips North America064
Toshiba American Medical Systems Inc040
Toshiba America Medical Systems, In.C350
General Electric Co.310
Shanghai United Imaging Healthcare Co., Ltd.1216
Toshibamedical Systems Corporation270
Decided510(k)Device and applicantCode
Oct 16, 2026K260391AVIEW Aorta Metrics
Coreline Soft Co., Ltd., KR
JAK
Sep 29, 2026K261225CAS-One IR
Cascination AG, CH
JAK
Sep 22, 2026K261125BodyTom 64 (NL4100); OmniTom Elite (NL5000)
Samsung HME America, Inc., dba NeuroLogica Corp.
JAK
Sep 18, 2026K261229SCENARIA View Phase 6.0
Fujifilm Corporation, JP
JAK
Sep 4, 2026K253836FCT iStream Phase 2
Fujifilm Corporation, JP
JAK
Jul 28, 2026K253450BodyTom Elite (NL4000)
NeuroLogica Corp., a Samsung Company
JAK
Jul 21, 2026K253770CardIQ Suite
GE Medical Systems SCS, FR
JAK
Jun 24, 2026K253560Enhanced Boundary for PCCT
Ge Medical Systems, LLC
JAK
Jun 4, 2026K253026Respiratory Gating for Scanners (2.1)
Varian Medical Systems, Inc.
JAK
May 20, 2026K253596Aquilion ONE (TSX-308A/TSX-306A) V2.0
Canon Medical Systems Corporation, JP
JAK
Mar 27, 2026K253649Spectral CT Verida Family
Philips Medical Systems Technologies , Ltd., IL
JAK
Mar 23, 2026K253686True Definition DL
Ge Healthcare Japan Corporation, JP
JAK
Mar 23, 2026K252992CT Rembra RT; CT Areta RT; CT Rembra
Philips Healthcare (Suzhou) Co., Ltd., CN
JAK
Mar 20, 2026K253574SOMATOM X.cite; SOMATOM X.ceed
Siemens Medical Solutions USA, Inc.
JAK
Mar 20, 2026K253520Photonova Spectra, Photonova Spectra Select
Ge Medical Systems, LLC
JAK
Mar 13, 2026K260078Aquilion ServeSP (TSX-307B) V2.0
Canon Medical Systems Corporation
JAK
Mar 13, 2026K252249Extremity CT Imaging System
Mars Bioimaging , Ltd., NZ
JAK
Mar 6, 2026K260167Bunkerhill Contrast AVC
BunkerHill Health
JAK
Mar 6, 2026K260166Bunkerhill Contrast CAC
BunkerHill Health
JAK
Mar 5, 2026K260169AV Cardiac CT
Philips Medical Systems Nederland B.V., NL
JAK
Jan 20, 2026K253173uCT 780 with uWS-CT-Dual Energy Analysis
Shanghai United Imaging Healthcare Co., Ltd., CN
JAK
Nov 28, 2025K252217CT VScore+
Canon Medical Informatics, Inc.
JAK
Oct 15, 2025K251805syngo.CT Dual Energy
Siemens Medical Solutions USA, Inc.
JAK
Oct 3, 2025K250662Bunkerhill MAC
BunkerHill Health
JAK
Oct 2, 2025K250766LungQ 4
Thirona BV, NL
JAK
Sep 26, 2025K251645Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6 with Calculated DAP
Canon Medical Systems Corporation, JP
JAK
Sep 8, 2025K250928OmniTom Elite with PCD
Neurologica Corporation
JAK
Aug 28, 2025K251484CT:VQ
4Dmedical Limited, AU
JAK
Aug 1, 2025K250941Revolution Vibe
Ge Medical Systems, LLC
JAK
Jul 28, 2025K251061NAEOTOM Alpha.Peak/NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime
Siemens Medical Solutions USA, Inc.
JAK
Jul 25, 2025K250970Marie
Leo Cancer Care
JAK
Jul 3, 2025K250822SOMATOM go.Now; SOMATOM go.Up; SOMATOM go.All; SOMATOM go.Top; SOMATOM go.Sim; SOMATOM go.Open Pro; SOMATOM Pro.Pulse
Siemens Medical Solutions USA, Inc.
JAK
Jun 27, 2025K250648Philips iCT CT system
Philips Medical Systems Nederland B.V., IL
JAK
Jun 20, 2025K243398CT Scanner TSX-501R/1 V11.1
Canon Medical Systems Corporation, JP
JAK
Jun 18, 2025K243672CardIQ Suite
GE Medical Systems SCS, FR
JAK
May 20, 2025K250370SCENARIA View Phase 5.0
Fujifilm Corporation, JP
JAK
May 16, 2025K244008Spectral CT
Philips Medical Systems Technologies , Ltd., IL
JAK
May 16, 2025K243617uCT ATLAS Astound with uWS-CT-Dual Energy Analysis; uCT ATLAS with uWS-CT-Dual Energy Analysis
Shanghai United Imaging Healthcare Co., Ltd., CN
JAK
Apr 15, 2025K250650SpotLight / SpotLight Duo with Low Dose Lung Cancer Screening Option
Arineta , Ltd., IL
JAK
Apr 10, 2025K243240Vitrea CT VScore
Canon Medical Informatics, Inc.
JAK
Mar 14, 2025K242811BodyTom 64
Neurologica Corporation, A Subsidiary of Samsung
JAK
Feb 19, 2025K242411Brainomix 360 e-Lung
Brainomix Limited, GB
JAK
Feb 12, 2025K243523NAEOTOM Alpha.Peak/ NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime
Siemens Medical Solutions USA, Inc.
JAK
Jan 27, 2025K243229Bunkerhill AVC
BunkerHill Health
JAK
Jan 14, 2025K241166uCT 550
Shanghai United Imaging Healthcare Co., Ltd., CN
JAK
Jan 13, 2025K241200SpotLight/SpotLight Duo with Low Dose Lung Cancer Screening Option
Arineta , Ltd., IL
JAK
Jan 7, 2025K241079uCT 780
Shanghai United Imaging Healthcare Co., Ltd., CN
JAK
Jan 3, 2025K241757syngo.CT Dual Energy
Siemens Medical Solutions USA, Inc.
JAK
Dec 23, 2024K242403Aquilion ONE (TSX-308A/3) V1.5
Canon Medical Systems Corporation, JP
JAK
Dec 3, 2024K242188ClearRead CT CAC
Riverain Technologies, Inc.
JAK

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