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

    CESIUM 137 SOURCE, MODEL CSM-40

    K Number: K882449 · Decision Apr 14, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    5
    Applicant Total
    9
    Review Days
    304

    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
    CESIUM 137 SOURCE, MODEL CSM-40
    K Number
    K882449
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.5730
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Cis-Us, Inc.
    Date Received
    June 14, 1988
    Decision Date
    April 14, 1989
    Product Code
    IWI
    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
    IWI Source, Isotope, Sealed, Gold, Titanium, Platinum

    Similar 510(k) Clearances

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

    NORTH AMERICAN SCIENTIFIC(NASI)PD-103 RADIONUCLIDE BRACHYTHERAPY SOURCE-MODEL MED3633

    FDA 510(k)
    FDA Class 2 ·Radiology

    I-125 RAPID STRAND

    FDA 510(k)
    FDA Class 2 ·Radiology

    RADIOACTIVE IODINE-125 SOURCES

    FDA 510(k)
    FDA Class 2 ·Radiology

    MODIFIED PALLADIUM SEED MODEL 100

    FDA 510(k)
    FDA Class 2 ·Radiology

    PALLADIUM SEED MODEL 100

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

    Other Clearances by Cis-Us, Inc.

    K Number Device Name
    K951708 ELSA-HCT
    K950211 ELSA-PTH
    K890799 CURIETRON 192 HIGH DOSE RATE
    K871502 PERSONNEL PROTECTIVE SHIELD
    K865027 IRRADIATOR FOR BIOLOGICAL MATERIALS, IBL-137C
    K863778 VENTICIS II
    K860823 ELSA-PROL IMMUNORADIOMETRIC ASSAY KIT
    K860824 TSHK-NN RIA KIT