LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K100001
    Device Name
    MOBIVISION
    Manufacturer
    ALMANA MEDICAL IMAGING
    Date Cleared
    2010-06-25

    (172 days)

    Product Code
    MQB,IZL
    Regulation Number
    892.1680
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MOBIVISION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    These Digital Radiographic Systems are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone supine position. Not for mammographic use.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for "Mobivision Digital Mobile X-Ray Systems (various models)". It confirms the device's substantial equivalence to predicate devices and outlines regulatory requirements.

    However, this document does not contain any information about acceptance criteria, study details, device performance, sample sizes, ground truth establishment, expert qualifications, or adjudication methods.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given text.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1