LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K020588
    Device Name
    X-IMAGE DIGITAL X-RAY SYSTEM
    Manufacturer
    ESCAPE TECHNOLOGY, INC.
    Date Cleared
    2002-06-13

    (111 days)

    Product Code
    MUH
    Regulation Number
    872.1800
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    ESCAPE TECHNOLOGY, INC.

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

    The X-Image Digital X-ray System is a software intended for dental radiographic examination and diagnosis of the teeth, jaw and oral structure by using scanned dental x-ray images sent through the digital x-ray sensor.

    Device Description

    Not Found

    AI/ML Overview

    This 510(k) summary does not contain the information requested to comprehensively describe the acceptance criteria and the study proving the device meets those criteria.

    The provided document is a clearance letter from the FDA for a 510(k) premarket notification. It states that the device is "substantially equivalent" to legally marketed predicate devices, meaning it doesn't require a new clinical trial to prove safety and effectiveness.

    Here's why the requested information isn't available in this document:

    • Acceptance Criteria and Reported Device Performance: This document only provides the "Indications For Use" for the X-Image Digital X-ray System (a software intended for dental radiographic examination and diagnosis). It does not specify any acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) or present performance metrics for the device itself.
    • Study Details (Sample size, data provenance, experts, adjudication, MRMC, standalone, ground truth, training set): A 510(k) clearance based on substantial equivalence does not typically involve the detailed study reports that would contain this information. The FDA determined equivalence to existing predicate devices, implying that the new device is expected to perform similarly within its stated indications for use.

    In summary, the provided document does not offer the necessary details about performance studies, acceptance criteria, or ground truth establishment for the X-Image Digital X-ray System. To obtain such information, one would need to refer to the actual 510(k) submission itself (which often includes technical specifications, testing summaries, and comparisons to predicate devices), or any independent studies published on the device.

    Therefore, I cannot populate the requested table or answer the subsequent questions based on the provided text.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1