JAK

System, X-Ray, Tomography, Computed

Product code
JAK
Device name
System, X-Ray, Tomography, Computed
Device class
Class 2
21 CFR
21 CFR 892.1750
Medical specialty
Radiology
Marketing pathway
510(K)
Flag
Third-party review eligible
510(k) clearances (last 3 years)
81
Summaries archived here
77 (direct download)
510(k) clearances (all years, FDA)
822 (all years; only the last 3 years are listed here)

510(k) clearances, last 3 years (81)

Last three years. Most recent: 2026-07-28.

NumberDecision dateApplicantDevice nameSummary
K2534502026-07-28NeuroLogica Corp., a Samsung CompanyBodyTom Elite (NL4000)PDF
K2537702026-07-21GE Medical Systems SCSCardIQ SuitePDF
K2535602026-06-24Ge Medical Systems, LLCEnhanced Boundary for PCCTPDF
K2530262026-06-04Varian Medical Systems, Inc.Respiratory Gating for Scanners (2.1)PDF
K2535962026-05-20Canon Medical Systems CorporationAquilion ONE (TSX-308A/TSX-306A) V2.0PDF
K2536492026-03-27Philips Medical Systems Technologies ,…Spectral CT Verida FamilyPDF
K2529922026-03-23Philips Healthcare (Suzhou) Co., Ltd.CT Rembra RT; CT Areta RT; CT RembraPDF
K2536862026-03-23Ge Healthcare Japan CorporationTrue Definition DLPDF
K2535742026-03-20Siemens Medical Solutions USA, Inc.SOMATOM X.cite; SOMATOM X.ceedPDF
K2535202026-03-20Ge Medical Systems, LLCPhotonova Spectra, Photonova Spectra SelectPDF
K2522492026-03-13Mars Bioimaging , Ltd.Extremity CT Imaging SystemPDF
K2600782026-03-13Canon Medical Systems CorporationAquilion ServeSP (TSX-307B) V2.0PDF
K2601662026-03-06BunkerHill HealthBunkerhill Contrast CACPDF
K2601672026-03-06BunkerHill HealthBunkerhill Contrast AVCPDF
K2601692026-03-05Philips Medical Systems Nederland B.V.AV Cardiac CTPDF
K2531732026-01-20Shanghai United Imaging Healthcare Co.…uCT 780 with uWS-CT-Dual Energy AnalysisPDF
K2522172025-11-28Canon Medical Informatics, Inc.CT VScore+PDF
K2518052025-10-15Siemens Medical Solutions USA, Inc.syngo.CT Dual EnergyPDF
K2506622025-10-03BunkerHill HealthBunkerhill MACPDF
K2507662025-10-02Thirona BVLungQ 4PDF
K2516452025-09-26Canon Medical Systems CorporationSelf-Propelled CT Scan Base Kit, CGBA-035A; Alphenix…PDF
K2509282025-09-08Neurologica CorporationOmniTom Elite with PCDPDF
K2514842025-08-284Dmedical LimitedCT:VQPDF
K2509412025-08-01Ge Medical Systems, LLCRevolution VibePDF
K2510612025-07-28Siemens Medical Solutions USA, Inc.NAEOTOM Alpha.Peak/NAEOTOM Alpha; NAEOTOM Alpha.Pro;…PDF
K2509702025-07-25Leo Cancer CareMarieFDA
K2508222025-07-03Siemens Medical Solutions USA, Inc.SOMATOM go.Now; SOMATOM go.Up; SOMATOM go.All; SOMAT…PDF
K2506482025-06-27Philips Medical Systems Nederland B.V.Philips iCT CT systemPDF
K2433982025-06-20Canon Medical Systems CorporationCT Scanner TSX-501R/1 V11.1PDF
K2436722025-06-18GE Medical Systems SCSCardIQ SuitePDF
K2503702025-05-20Fujifilm CorporationSCENARIA View Phase 5.0PDF
K2436172025-05-16Shanghai United Imaging Healthcare Co.…uCT ATLAS Astound with uWS-CT-Dual Energy Analysis; …PDF
K2440082025-05-16Philips Medical Systems Technologies ,…Spectral CTPDF
K2506502025-04-15Arineta , Ltd.SpotLight / SpotLight Duo with Low Dose Lung Cancer …PDF
K2432402025-04-10Canon Medical Informatics, Inc.Vitrea CT VScorePDF
K2428112025-03-14Neurologica Corporation, A Subsidiary …BodyTom 64PDF
K2424112025-02-19Brainomix LimitedBrainomix 360 e-LungPDF
K2435232025-02-12Siemens Medical Solutions USA, Inc.NAEOTOM Alpha.Peak/ NAEOTOM Alpha; NAEOTOM Alpha.Pro…PDF
K2432292025-01-27BunkerHill HealthBunkerhill AVCPDF
K2411662025-01-14Shanghai United Imaging Healthcare Co.…uCT 550PDF
K2412002025-01-13Arineta , Ltd.SpotLight/SpotLight Duo with Low Dose Lung Cancer Sc…PDF
K2410792025-01-07Shanghai United Imaging Healthcare Co.…uCT 780PDF
K2417572025-01-03Siemens Medical Solutions USA, Inc.syngo.CT Dual EnergyPDF
K2424032024-12-23Canon Medical Systems CorporationAquilion ONE (TSX-308A/3) V1.5PDF
K2421882024-12-03Riverain Technologies, Inc.ClearRead CT CACPDF
K2428742024-11-21Varian Medical Systems, Inc.Gating Reflector BlockPDF
K2408442024-10-18Philips Medical Systems Technologies ,…Spectral CT 7500 RTPDF
K2403692024-09-27BunkerHill HealthCAC (gated) AlgorithmPDF
K2412952024-09-03Siemens Medical Solutions USA, Inc.SOMATOM On.sitePDF
K2414402024-08-19Nano-X AI , Ltd.HealthCCSngPDF
K2337312024-08-01GE Medical Systems SCSCardIQ SuiteFDA
K2417132024-07-12Curvebeam, LLCHiRise (1040-230)PDF
K2337672024-06-10Neurologica CorporationOmniTom ElitePDF
K2338752024-05-13Brainomix LimitedBrainomix 360 e-LungPDF
K2324912024-05-03Philips Healthcare (Suzhou) Co., Ltd.CT 5300PDF
K2335832024-04-26FUJIFILM Healthcare Americas Corporati…FCT iSTREAM Phase 1PDF
K2336982024-04-11Ge Healthcare Japan CorporationTrue Enhance DLPDF
K2322272024-04-04Neuwave Medical, Inc.ABLATE-IQPDF
K2328352024-04-02Canon Medical Systems CorporationAquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruct…PDF
K2337502024-04-02Ge Medical Systems, LLCECG-less CardiacFDA
K2336572024-03-28Siemens Medical Solutions USA, Inc.NAEOTOM AlphaPDF
K2336502024-03-26Siemens Medical Solutions USA, Inc.SOMATOM go.Up; SOMATOM go.Now; SOMATOM go.All; SOMAT…FDA
K2337532024-03-21Siemens Healthcare GmbHAI-Rad Companion (Pulmonary)PDF
K2320222024-03-13Cascination AGCAS-One IRPDF
K2337492024-02-22Ge Hangwei Medical Systems Co., Ltd.Revolution Ascend SlidingPDF
K2330802024-02-08Nano-X AI , Ltd.HealthFLDPDF
K2340302024-01-17Clear Guide MedicalClear Guide SCENERGYPDF
K2324122024-01-08Thirona BVLungQ v3.0.0PDF
K2321362024-01-04Siemens Medical Solutions USA, Inc.syngo.CT ApplicationsPDF
K2322062023-12-06Siemens Medical Solutions USA, Inc.SOMATOM Pro.PulsePDF
K2333342023-12-06Canon Medical Systems CorporationAquilion Serve SP (TSX-307B/1) V1.3PDF
K2321552023-11-30Siemens Medical Solutions USA, Inc.syngo.CT Dual EnergyPDF
K2314822023-11-29Shanghai United Imaging Healthcare Co.…uCT ATLAS Astound with uWS-CT-Dual Energy Analysis, …PDF
K2316312023-11-28Aidoc Medical , Ltd.BriefCase-QuantificationPDF
K2323922023-11-164Dmedical LimitedCT Lung Ventilation Analysis Software (CT:V)PDF
K2320452023-10-27MeVis Medical Solutions AGMeVis Liver SuitePDF
K2303702023-10-13Arineta , Ltd.SpotLight/SpotLight Duo (with DLIR option)PDF
K2315742023-10-12FUJIFILM Healthcare Americas Corporati…Scenaria View 4.2PDF
K2302202023-10-11Neusoft Medical Systems Co., Ltd.NeuViz 128 Multi-Slice CT Scanner SystemPDF
K2301302023-10-10Isys Medizintechnik GmbHMicromate™ Navi+PDF
K2312812023-09-19Canon Medical Systems CorporationAquilion Serve (TSX-307A/1) V1.3PDF

77 summaries are archived here for direct download.

Official FDA classification page: JAK
Classification and pathway per current FDA publications. Data from openFDA (CC0).