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

    RADIONUCLIDE COMPUTED TOMOGRAPHY SYS.

    K Number: K770220 · Decision Feb 28, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    85
    Registration Numbers
    85
    Same Product Code
    470
    Applicant Total
    56
    Review Days
    25

    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
    RADIONUCLIDE COMPUTED TOMOGRAPHY SYS.
    K Number
    K770220
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1200
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    G.D. Searle and Co.
    Date Received
    February 3, 1977
    Decision Date
    February 28, 1977
    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

    Similar 510(k) Clearances

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

    Symbia Pro.specta Q3 (11364751);Symbia Pro.specta X3 (11364752);Symbia Pro.specta X7 (11364753);Symbia Pro.specta VA40 Family

    FDA 510(k)
    FDA Class 2 ·Radiology

    uMI Panvivo (uMI Panvivo LS); uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES)

    FDA 510(k)
    FDA Class 2 ·Radiology

    uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES)

    FDA 510(k)
    FDA Class 2 ·Radiology

    VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464)

    FDA 510(k)
    FDA Class 2 ·Radiology

    AnyScan 3.0 NM Scanner Family

    FDA 510(k)
    FDA Class 2 ·Radiology

    Cartesion Prime (PCD-1000A/3) V10.21

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

    Other Clearances by G.D. Searle and Co.

    K Number Device Name
    K821159 IN-LINE OXYGEN MONITORING SYSTEM
    K811068 BYPASS COIL
    K811071 VENOUS OXYGEN PROBE
    K803238 INTRAVASCULAR CATHETER
    K810630 SILICONE ELASTOMER COATED LATEX FOLEY
    K810131 ADMINISTRATION SET
    K802485 SEARLE VASCULAR LOOPS
    K801805 METRONIDAZOLE DISCS
    K810112 SWR DISPOSABLE PREP RAZOR
    K802213 WHITE KNIGHT BOVIE CORD/SUCTION TUBE
    Search all 56 clearances from G.D. Searle and Co. →