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

    CONVERGENCE NUA FOR HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERAS

    K Number: K991318 · Decision Jun 18, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    85
    Registration Numbers
    85
    Same Product Code
    470
    Applicant Total
    32
    Review Days
    60

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    Basic Information

    Device Name
    CONVERGENCE NUA FOR HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERAS
    K Number
    K991318
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1200
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hitachi Medical Corp. of America
    Date Received
    April 19, 1999
    Decision Date
    June 18, 1999
    Product Code
    KPS
    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
    KPS System, Tomography, Computed, Emission

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    Other Clearances by Hitachi Medical Corp. of America

    K Number Device Name
    K994026 EUB-6000 ULTRASOUND DIAGNOSTIC SCANNER
    K991535 CONVERGENCE CDR FOR HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERAS
    K991129 HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERA SYSTEM WITH THICK NAL(TI) CRYSTAL
    K981434 EUP-OL334 LAPARASCOPICPROBE
    K954220 EUB-8000
    K962308 EUB-905
    K954143 HITACHI SPECTRADIGITAL SERIES GAMMA CAMERA SYSTEMS
    K954129 SPECTRADIGITAL SERIES V250DSP
    K945400 HITACHI DYNAMIC 3D IMAGING SYSTEM,SF-VA100
    K945795 EUB-555A+
    Search all 32 clearances from Hitachi Medical Corp. of America →