BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    Accipiolx

    K Number: K201310 · Decision Aug 7, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    85
    Applicant Total
    1
    Review Days
    84

    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
    Accipiolx
    K Number
    K201310
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2080
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Maxq AL , Ltd.
    Date Received
    May 15, 2020
    Decision Date
    August 7, 2020
    Product Code
    QAS
    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
    QAS Radiological Computer-Assisted Triage And Notification Software

    Similar 510(k) Clearances

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

    Vascular Assist Occlusion Triage (VAOT) (v1.0)

    FDA 510(k)
    FDA Class 2 ·Radiology

    BriefCase-Triage

    FDA 510(k)
    FDA Class 2 ·Radiology

    EFAI ERSUITE CT APPENDICITIS ASSESSMENT SYSTEM (APPEN-CT-100)

    FDA 510(k)
    FDA Class 2 ·Radiology

    JLK-NCCT

    FDA 510(k)
    FDA Class 2 ·Radiology

    Annalise Enterprise

    FDA 510(k)
    FDA Class 2 ·Radiology

    BriefCase-Triage: CARE Multi-Triage CT for Pneumothorax; Pericardial effusion; Large aortic aneurysm; Shoulder fracture or dislocation device

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