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

    CAPTUS 500 WELL DETECTOR W/CLINICAL LABOR SOFTWARE

    K Number: K924586 · Decision Dec 3, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    29
    Applicant Total
    7
    Review Days
    84

    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
    CAPTUS 500 WELL DETECTOR W/CLINICAL LABOR SOFTWARE
    K Number
    K924586
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    892.1320
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Capintec Instruments, Inc.
    Date Received
    September 10, 1992
    Decision Date
    December 3, 1992
    Product Code
    IZD
    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
    IZD Probe, Uptake, Nuclear

    Similar 510(k) Clearances

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

    DECLIPSESPECT LAPAROSCOPY

    FDA 510(k)
    FDA Class 1 ·Radiology

    DECLIPSESPECT VIEWER

    FDA 510(k)
    FDA Class 1 ·Radiology

    CONFIDENT SURGERY SUITE 300, MODEL CSS300

    FDA 510(k)
    FDA Class 1 ·Radiology

    HANDHELD GAMMA FINDER (HGF)

    FDA 510(k)
    FDA Class 1 ·Radiology

    MODIFICATION TO GAMMA GUIDANCE SYSTEM

    FDA 510(k)
    FDA Class 1 ·Radiology

    C-TRAK AUTOMATIC ANALYZER (NAME CHANGE FROM ONCOPROBE II TO C-TRAK)

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

    Other Clearances by Capintec Instruments, Inc.

    K Number Device Name
    K943072 BETA C COUNTER
    K935539 CAPINTEC CRC 35R
    K930962 CAPTUS 2000 WEL COUNTER
    K921428 CAPTUS 500
    K910020 CAPINTEC THYROID UPTAKE SYSTEM-VARIOUS MODELS
    K905796 DOSE CALIBRATOR