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

    BLADDER SCANNER

    K Number: K113304 · Decision Mar 23, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    345
    Registration Numbers
    346
    Same Product Code
    883
    Applicant Total
    2
    Review Days
    136

    Basic Information

    Device Name
    BLADDER SCANNER
    K Number
    K113304
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1560
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    MEDA CO. LTD.
    Date Received
    November 8, 2011
    Decision Date
    March 23, 2012
    Product Code
    IYO
    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
    IYO System, Imaging, Pulsed Echo, Ultrasonic

    Similar 510(k) Clearances

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

    B-Scan

    FDA 510(k)
    FDA Class 2 ·Radiology

    Velacur One (LI-1100)

    FDA 510(k)
    FDA Class 2 ·Radiology

    Accuro 3S

    FDA 510(k)
    FDA Class 2 ·Radiology

    EchoGuide (Version 1)

    FDA 510(k)
    FDA Class 2 ·Radiology

    Portable Liver Elastography Ultrasound Diagnostic System (Liverscan C)

    FDA 510(k)
    FDA Class 2 ·Radiology

    SpineUs™ System

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

    Other Clearances by MEDA CO. LTD.

    K Number Device Name
    K121243 ULTRASONIC BIOMETER FOR OPHTHALMOLOGY ULTRASONIC PACHYMETER