BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    MD-2300S Ultrasonic A/B Scanner for Ophthalmology

    K Number: K152318 · Decision Nov 17, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    348
    Registration Numbers
    349
    Same Product Code
    892
    Applicant Total
    5
    Review Days
    92

    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
    MD-2300S Ultrasonic A/B Scanner for Ophthalmology
    K Number
    K152318
    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
    August 17, 2015
    Decision Date
    November 17, 2015
    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.

    ARTHUR

    FDA 510(k)
    FDA Class 2 ·Radiology

    EdgeFlow UW20

    FDA 510(k)
    FDA Class 2 ·Radiology

    Accuro XV

    FDA 510(k)
    FDA Class 2 ·Radiology

    QT Scanner 2000 Model A

    FDA 510(k)
    FDA Class 2 ·Radiology

    IntraSight Plus

    FDA 510(k)
    FDA Class 2 ·Radiology

    Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro)

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

    Other Clearances by MEDA Co., Ltd.

    K Number Device Name
    K213070 MD-320W Ultrasound Biomicroscope
    K182460 MD-6000P Bladder Scanner
    K121243 ULTRASONIC BIOMETER FOR OPHTHALMOLOGY ULTRASONIC PACHYMETER
    K113304 BLADDER SCANNER