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

    IMATION SE-196 LASER IMAGER

    K Number: K972163 · Decision Sep 5, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    120
    Applicant Total
    5
    Review Days
    88

    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
    IMATION SE-196 LASER IMAGER
    K Number
    K972163
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2040
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Imation Corp.
    Date Received
    June 9, 1997
    Decision Date
    September 5, 1997
    Product Code
    LMC
    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
    LMC Camera, Multi Format, Radiological

    Similar 510(k) Clearances

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

    SONY DIGITAL PRINTER UP-D898MD/SONY HYBRID PRINTER UP-X898MD

    FDA 510(k)
    FDA Class 2 ·Radiology

    SONY HYBIRD GRAPHIC UP-971AD, SONY HYBIRD GRAPHIC PRINTER UP-991AD

    FDA 510(k)
    FDA Class 2 ·Radiology

    DRYVIEW CHROMA IMAGING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    CYPHER DICOM PRINT SOLUTION

    FDA 510(k)
    FDA Class 2 ·Radiology

    CARESTREAM DRYVIEW 5850 LASER IMAGER

    FDA 510(k)
    FDA Class 2 ·Radiology

    SONY UP-DF750 DIGITAL FILM IMAGER

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

    Other Clearances by Imation Corp.

    K Number Device Name
    K984252 IMATION TRIMATIC DIGITAL SYSTEM
    K980722 TRIMAX RADIOGRAPHIC CASSETTE
    K973303 IMATION MODEL 9410 NETWORK INTERFACE
    K962750 3M TRIMATIC MODULAR ADVANCED PROCESSING SYSTEM AND 3M APS AUTOMATIC FILM PROCESSOR