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

    10 X 10 VISION

    K Number: K091928 · Decision Jun 16, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    26
    Applicant Total
    4
    Review Days
    351

    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
    10 X 10 VISION
    K Number
    K091928
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1680
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bioptics, Inc.
    Date Received
    June 30, 2009
    Decision Date
    June 16, 2010
    Product Code
    MWP
    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
    MWP Cabinet, X-Ray System

    Similar 510(k) Clearances

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

    TrueView Core 100Pro-US Core Specimen Radiography System (TrueView Core 100Pro-US)

    FDA 510(k)
    FDA Class 2 ·Radiology

    TrueView 200 Pro-US Specimen Radiography System (TrueView 200 Pro-US)

    FDA 510(k)
    FDA Class 2 ·Radiology

    Solas OR

    FDA 510(k)
    FDA Class 2 ·Radiology

    Kubtec Mozart Supra (XPERT 84) Radiography System

    FDA 510(k)
    FDA Class 2 ·Radiology

    Kubec Xpert 80 Radiography System

    FDA 510(k)
    FDA Class 2 ·Radiology

    Kubtec Mozart (XPERT42)

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

    Other Clearances by Bioptics, Inc.

    K Number Device Name
    K091558 BIOVISION DIGITAL SPECIMEN RADIOGRAPHY SYSTEM
    K082432 CORE VISION DIGITAL SPECIMEN RADIOGRAPHY (DSR) SYSTEM
    K052433 PIXARRAY 100 DIGITAL SPECIMEN RADIOGRAPHY (DSR) SYSTEM