BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇫🇷 France

    Epione

    K Number: K211645 · Decision Feb 24, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    163
    Registration Numbers
    163
    Same Product Code
    818
    Applicant Total
    2
    Review Days
    272

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    Epione
    K Number
    K211645
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1750
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Quantum Surgical Sas
    Date Received
    May 28, 2021
    Decision Date
    February 24, 2022
    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 Quantum Surgical Sas

    K Number Device Name
    K223758 Epione