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

    IMWXDOP IR

    K Number: K944196 · Decision May 12, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    37
    Applicant Total
    19
    Review Days
    256

    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
    IMWXDOP IR
    K Number
    K944196
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1540
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Imex Medical Systems, Inc.
    Date Received
    August 29, 1994
    Decision Date
    May 12, 1995
    Product Code
    JAF
    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
    JAF Monitor, Ultrasonic, Nonfetal

    Similar 510(k) Clearances

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

    Laminar P1 (LDH-HW-001)

    FDA 510(k)
    FDA Class 2 ·Radiology

    THD REVOLUTION

    FDA 510(k)
    FDA Class 2 ·Radiology

    SIMPLEABI

    FDA 510(k)
    FDA Class 2 ·Radiology

    LIFEDOP MODEL 300ABI

    FDA 510(k)
    FDA Class 2 ·Radiology

    THD SLIDE ONE

    FDA 510(k)
    FDA Class 2 ·Radiology

    THD SLIDE

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

    Other Clearances by Imex Medical Systems, Inc.

    K Number Device Name
    K973556 IMEX MEDICAL SYSTEMS, INC. IMEXLAB 9000
    K973562 IMEX MEDICAL SYSTEMS, INC. IMEXLAB 9100
    K973336 IMEX STETHODOP
    K970156 IMEX FUTURALDOP PRO
    K942243 IMEX 8000 PERSONAL CASCULAR LAB
    K942441 IMEXDOP CT+
    K910462 POCKET DOP 3
    K901593 IMEX DOP-TONE II
    K896613 FLAT VASCULAR PROBE
    K882138 IMEXLAB 3000 VASCULAR DIAGNOSTIC RECORDER
    Search all 19 clearances from Imex Medical Systems, Inc. →