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

    JUSHA-M52C MEDICAL DISPLAY

    K Number: K131390 · Decision Nov 27, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    599
    Registration Numbers
    599
    Same Product Code
    2271
    Applicant Total
    26
    Review Days
    197

    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
    JUSHA-M52C MEDICAL DISPLAY
    K Number
    K131390
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nanjing Jusha Display Technology Co., Ltd.
    Date Received
    May 14, 2013
    Decision Date
    November 27, 2013
    Product Code
    LLZ
    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
    LLZ System, Image Processing, Radiological

    Similar 510(k) Clearances

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

    2D Hip Planning Software

    FDA 510(k)
    FDA Class 2 ·Radiology

    CustoMED Viewer

    FDA 510(k)
    FDA Class 2 ·Radiology

    Helion Viewer Suite

    FDA 510(k)
    FDA Class 2 ·Radiology

    CMN Capillary Function with Virtual Expert for MRI, CT and CBCT

    FDA 510(k)
    FDA Class 2 ·Radiology

    SubtleHD-PET (1.x)

    FDA 510(k)
    FDA Class 2 ·Radiology

    HipGuide (V 1.0.0.0)

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

    Other Clearances by Nanjing Jusha Display Technology Co., Ltd.

    K Number Device Name
    K230728 JUSHA-C810G/C810G LCD Monitor, JUSHA-C660/JUSHA-C660G/C660/C660G LCD Monitor
    K231170 C350/C350G LCD Monitor; M550/M550G LCD Monitor
    K230723 C510G/JUSHA-C510G/C510/JUSHA- C510 LCD Monitor
    K230643 CP620G LCD monitor, CP620 LCD monitor
    K222121 C630G LCD monitor, JUSHA-C630G LCD monitor, C630 LCD monitor, JUSHA-C630 LCD monitor
    K212231 C1210G LCD Monitor, JUSHA-C1210G LCD Monitor, C1210 LCD Monitor, JUSHA-C1210 LCD Monitor
    K200742 JUSHA-CP610 LCD Monitor
    K190831 E240AG LCD Monitor, E240A LCD Monitor, JUSHA-E240AG LCD Monitor, JUJSHA-E240A LCD Monitor, C230A LCD Monitor, JUSHA-C230A LCD Monitor, C230M LCD Monitor, JUSHA-C230M LCD Monitor
    K190848 JUSHA-M550G/ JUSHA-M550/M550G/M550 LCD Monitor
    K183496 JUSHA-C350G LCD Monitor, JUSHA-C350 LCD Monitor, C350G LCD Monitor, C350 LCD Monitor
    Search all 26 clearances from Nanjing Jusha Display Technology Co., Ltd. →