BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    SONY DKR-700 DIGITAL STILL RECORDER

    K Number: K961680 · Decision Jul 3, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    61
    Registration Numbers
    61
    Same Product Code
    54
    Applicant Total
    6
    Review Days
    63

    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
    SONY DKR-700 DIGITAL STILL RECORDER
    K Number
    K961680
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    892.2010
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sony Medical Systems
    Date Received
    May 1, 1996
    Decision Date
    July 3, 1996
    Product Code
    LMB
    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
    LMB Device, Digital Image Storage, Radiological

    Similar 510(k) Clearances

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

    SAMSUNG RAYPAX LONG TERM ARCHIVE

    FDA 510(k)
    FDA Class 1 ·Radiology

    ECHOLIVE FAMILY, MODELS: ZL-1010,ZL-2000,ZL-2100,ZL-3000,ZL-4000

    FDA 510(k)
    FDA Class 1 ·Radiology

    WISE (II) IMAGE MANAGEMENT SYSTEM

    FDA 510(k)
    FDA Class 1 ·Radiology

    PARAMETER DEVELOPMENTS DICOM ARCHIVAL SERVER, (DAS)/DICOM INTRANET SERVICE (DIS)

    FDA 510(k)
    FDA Class 1 ·Radiology

    OLICON IMAGING SYSTEMS, INC. ARCHIVE SYSTEMS, NT ARCHIVE, 02ARCHIVE, ARCHIVE

    FDA 510(k)
    FDA Class 1 ·Radiology

    ID. STORE (RELEASE 2.0)

    FDA 510(k)
    FDA Class 1 ·Radiology
    View all

    Other Clearances by Sony Medical Systems

    K Number Device Name
    K024188 UP-DF500 FILMSTATION DIGITAL FILM IMAGER
    K970999 SONY PGM-100P1MD TRINITRON COLOR GRAPHIC MONITOR
    K931170 SONY CARDIAC ANALYSIS AND REVIEW STATION (CARS)
    K924708 CINENET CARDIAC IMAGE NETWORK
    K921275 SONY LASER VIDEODISC RECORDING SYSTEM