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

    KONICA DIRECT DIGITIZER REGIUS MODEL 330

    K Number: K980873 · Decision Jun 19, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    60
    Applicant Total
    5
    Review Days
    105

    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
    KONICA DIRECT DIGITIZER REGIUS MODEL 330
    K Number
    K980873
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2030
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Konica Corp.
    Date Received
    March 6, 1998
    Decision Date
    June 19, 1998
    Product Code
    LMA
    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
    LMA Digitizer, Image, Radiological

    Similar 510(k) Clearances

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

    DICOM VIDEO

    FDA 510(k)
    FDA Class 2 ·Radiology

    TELERADPRO EDGE; TELERADPRO EDGE HD-CCD

    FDA 510(k)
    FDA Class 2 ·Radiology

    DIAGNOSTICPRO EDGE

    FDA 510(k)
    FDA Class 2 ·Radiology

    TELERADPRO

    FDA 510(k)
    FDA Class 2 ·Radiology

    VIDAR DENTAL FILM DIGITIZER

    FDA 510(k)
    FDA Class 2 ·Radiology

    MEDI-6000 MEDICAL IMAGE DIGITIZER

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

    Other Clearances by Konica Corp.

    K Number Device Name
    K992586 KONICA LASER IMAGER, DRYPRO MODEL 722
    K990359 KONICA DIRECT DIGITIZER, MODEL DD-341
    K920769 KONICA LI 10 AND 10A LASER IMAGER
    K920558 KONICA DIRECT DIGITIZER KD-1000