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

    RNS STERILE, DISPOSABLE RADIOGRAPHIC CONTRAST TRAY

    K Number: K955687 · Decision Jun 3, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    136
    Registration Numbers
    136
    Same Product Code
    299
    Applicant Total
    18
    Review Days
    172

    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
    RNS STERILE, DISPOSABLE RADIOGRAPHIC CONTRAST TRAY
    K Number
    K955687
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1650
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Contour Fabricators of Florida, Inc.
    Date Received
    December 14, 1995
    Decision Date
    June 3, 1996
    Product Code
    JAA
    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
    JAA System, X-Ray, Fluoroscopic, Image-Intensified

    Similar 510(k) Clearances

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

    Nexus DRF Digital X-ray Imaging System

    FDA 510(k)
    FDA Class 2 ·Radiology

    Insight Enhanced™ DRF (EN-1002-01)

    FDA 510(k)
    FDA Class 2 ·Radiology

    Soteria E-View

    FDA 510(k)
    FDA Class 2 ·Radiology

    Adora DRFi (04550010)

    FDA 510(k)
    FDA Class 2 ·Radiology

    TRIDENT Mobile Fluoroscopy System

    FDA 510(k)
    FDA Class 2 ·Radiology

    ProxiDiagnost N90 / Precision CRF (706110, 706400)

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

    Other Clearances by Contour Fabricators of Florida, Inc.

    K Number Device Name
    K955685 RNS STERILE, DISPOSABLE CT BIOPSY TRAY
    K962040 RNS ARTHROGRAM TRAY
    K955689 RNS STERILE, DISPOSABLE DIGITAL ANGIOGRAPHIC TRAY
    K955684 RNS STERILE, DISPOSABLE ANGIOGRAPHIC TRAY
    K955679 RNS STERILE, DISPOSABLE AMNIOCENTESIS TRAY
    K955688 RNS STERILE, DISPOSABLE STANDARD BIOPSY TRAY
    K955686 RNS, STERILE DISPOSABLE PERCUTANEOUS CHOLANGIOGRAPHIC TRAY
    K955678 RNS STERILE DISPOSABLE PUNCTURE TRAY
    K955683 RNS STERILE, DISPOSABLE BREAST BIOPSY/LOCALIZATION TRAY
    K952396 REDI NURSE SYSTEM (RNS) STERILE 0.9% SODIUM CHLORIDE SOLUTION
    Search all 18 clearances from Contour Fabricators of Florida, Inc. →