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

    REGIUS UNITEA

    K Number: K071436 · Decision Jun 27, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    609
    Registration Numbers
    609
    Same Product Code
    2221
    Applicant Total
    27
    Review Days
    35

    Basic Information

    Device Name
    REGIUS UNITEA
    K Number
    K071436
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    KONICA MINOLTA MEDICAL & GRAPHIC, INC.
    Date Received
    May 23, 2007
    Decision Date
    June 27, 2007
    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 KONICA MINOLTA MEDICAL & GRAPHIC, INC.

    K Number Device Name
    K130936 AERODR SYSTEM WITH P-31
    K123499 AEROPILOT
    K120752 AERODR STITCHING SYSTEM
    K121109 AERODR X70
    K120477 AEROSYNC FOR AERODR SYSTEM
    K120131 REGIUS SIGMA2
    K113248 AERODR SYSTEM WITH P-21
    K110717 KONICA MINOLTA XPRESS DIGITAL MAMMOGRAPHY SYSTEM
    K103703 REGUIS SIGMA
    K101842 ACIES
    Search all 27 clearances from KONICA MINOLTA MEDICAL & GRAPHIC, INC. →