BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    CTC WORKSTATION, MODEL 2200

    K Number: K062229 · Decision Sep 11, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    609
    Registration Numbers
    609
    Same Product Code
    2221
    Applicant Total
    57
    Review Days
    40

    Basic Information

    Device Name
    CTC WORKSTATION, MODEL 2200
    K Number
    K062229
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    MEDICAL DIAGNOSTIC TECHNOLOGIES, INC.
    Date Received
    August 2, 2006
    Decision Date
    September 11, 2006
    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 MEDICAL DIAGNOSTIC TECHNOLOGIES, INC.

    K Number Device Name
    K972209 SPECTROLYSE HEPARIN (ANTI-IIA)
    K963106 CHROMOLIZE PAI-1 KIT
    K960871 SPECTROLYSE ANTITHROMBIN III (ANTI-XA)
    K962489 CHROMOLIZE TPA ASSAY KIT
    K960438 TINTELIZE PAI-1 KIT
    K961724 U-DOA CONTROLS
    K961370 LA POSITIVE CONTROL PLASMA
    K955115 VENOM TIEM REAGENT
    K955738 BIOCLOT PROTEIN S
    K952746 ALKALINE PHOSPHATASE REAGENT SYSTEM
    Search all 57 clearances from MEDICAL DIAGNOSTIC TECHNOLOGIES, INC. →