BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇳🇱 Netherlands

    AV Cardiac CT

    K Number: K260169 · Decision Mar 5, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    163
    Registration Numbers
    163
    Same Product Code
    818
    Applicant Total
    104
    Review Days
    44

    Basic Information

    Device Name
    AV Cardiac CT
    K Number
    K260169
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1750
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Philips Medical Systems Nederland B.V.
    Date Received
    January 20, 2026
    Decision Date
    March 5, 2026
    Product Code
    JAK
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JAK System, X-Ray, Tomography, Computed

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (JAK), ordered by most recent decision date.

    Respiratory Gating for Scanners (2.1)

    FDA 510(k)
    FDA Class 2 ·Radiology

    Aquilion ONE (TSX-308A/TSX-306A) V2.0

    FDA 510(k)
    FDA Class 2 ·Radiology

    Spectral CT Verida Family

    FDA 510(k)
    FDA Class 2 ·Radiology

    True Definition DL

    FDA 510(k)
    FDA Class 2 ·Radiology

    CT Rembra RT; CT Areta RT; CT Rembra

    FDA 510(k)
    FDA Class 2 ·Radiology

    SOMATOM X.cite; SOMATOM X.ceed

    FDA 510(k)
    FDA Class 2 ·Radiology
    View all

    Other Clearances by Philips Medical Systems Nederland B.V.

    K Number Device Name
    K260207 Multimodality Simulation Workspace (MM Sim) (v1.0.0)
    K253614 EchoNavigator R5.0
    K253648 Ingenia, Ingenia CX, Ingenia Elition S/X, Ingenia Ambition S/X, BlueSeal SE/XE/QE, MR 5300 and MR 7700 MR Systems including Upgrades
    K253735 AV Vascular
    K254190 dS Base 1.5T; dS Base 3.0T; dS Head 1.5T; dS Head 3.0T; dS HeadNeck 1.5T; dS HeadNeck 3.0T
    K252645 LumiGuide Equipment R2.1; LumiGuide Wire; LumiGuide 3D Hub
    K251215 Philips IntelliSpace Cardiovascular
    K250181 AV Viewer
    K251808 Achieva; Intera; Ingenia 1.5T; Ingenia 3.0T; Ingenia 1.5T CX; Ingenia 3.0T CX; Ingenia Elition S; Ingenia Elition X; Ingenia Ambition S; Ingenia Ambition X; and MR 5300 MR Systems
    K250648 Philips iCT CT system
    Search all 104 clearances from Philips Medical Systems Nederland B.V. →