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

    QCU ANALYTICAL SOFTWARE PACKAGE

    K Number: K011582 · Decision Jul 31, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    609
    Registration Numbers
    609
    Same Product Code
    2221
    Applicant Total
    16
    Review Days
    69

    Basic Information

    Device Name
    QCU ANALYTICAL SOFTWARE PACKAGE
    K Number
    K011582
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    MEDIS MEDICAL IMAGING SYSTEMS, B.V.
    Date Received
    May 23, 2001
    Decision Date
    July 31, 2001
    Product Code
    LLZ
    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
    LLZ System, Image Processing, Radiological

    Similar 510(k) Clearances

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

    CustomSurg OrthoPlanner

    FDA 510(k)
    FDA Class 2 ·Radiology

    uOmniscan

    FDA 510(k)
    FDA Class 2 ·Radiology

    Mosaic (V1.0.1)

    FDA 510(k)
    FDA Class 2 ·Radiology

    UroNav 4

    FDA 510(k)
    FDA Class 2 ·Radiology

    TechLive

    FDA 510(k)
    FDA Class 2 ·Radiology

    SMARTDent

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

    Other Clearances by MEDIS MEDICAL IMAGING SYSTEMS, B.V.

    K Number Device Name
    K140587 MR-CT VVA
    K112807 X-RAY VVA
    K073156 QPLAQUE MR
    K062386 QANGIO CT
    K050703 QBRAIN
    K042383 RSA-CMS
    K041162 ORTHO-CMS
    K040746 MRA-CMS
    K033774 CT-MASS
    K023970 QUANTITATIVE VASCULAR ANGIOGRAPHY - CMS
    Search all 16 clearances from MEDIS MEDICAL IMAGING SYSTEMS, B.V. →