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

    ULTRA-PRO ULTRASOUND SCANNING TABLE MODEL #056-650

    K Number: K950981 · Decision Apr 3, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    76
    Applicant Total
    9
    Review Days
    31

    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
    ULTRA-PRO ULTRASOUND SCANNING TABLE MODEL #056-650
    K Number
    K950981
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1980
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biodex Medical Systems, Inc.
    Date Received
    March 3, 1995
    Decision Date
    April 3, 1995
    Product Code
    IXR
    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
    IXR Table, Radiographic, Tilting

    Similar 510(k) Clearances

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

    VISION R/F TILTING TABLE

    FDA 510(k)
    FDA Class 2 ·Radiology

    LEGACY/LEGACY-D TABLE

    FDA 510(k)
    FDA Class 2 ·Radiology

    CAP-35B III/CINE 275

    FDA 510(k)
    FDA Class 2 ·Radiology

    PHILIPS EASY DIAGNOST

    FDA 510(k)
    FDA Class 2 ·Radiology

    ELECTROPHYSIOLOGY TILT TABLE MODEL #9660

    FDA 510(k)
    FDA Class 2 ·Radiology

    FLUOROVIEW SERIES FLUOROSCOPIC TABLES

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

    Other Clearances by Biodex Medical Systems, Inc.

    K Number Device Name
    K090296 ATOMLAB 400 AND ATOMLAB 500 DOSE CALIBRATORS, MODELS 086-330, -331, -332, -335 AND -336
    K063666 SHARPS CONTAINER, MODEL 039-413
    K951770 BIODEX SYSTEM 3 MODEL S3S-AP AND MODEL S3D-3AP
    K942694 STABILITY SYSTEM (110V) MODEL 945-300; STABILITY SYSTEM (220V) MODEL #945-302
    K940301 COMPEX 2
    K935061 LOWER BODY CYCLES
    K935216 SEMI-RECUMBENT CYCLES
    K935520 UPPER BODY CYCLES (110 VOLT)/(220 VOLT)