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510(k) Data Aggregation

    K Number
    K043062
    Device Name
    MODEL SR-130-D PORTABLE DIGITAL X-RAY SYSTEM
    Manufacturer
    SOURCE-RAY, INC.
    Date Cleared
    2004-12-13

    (38 days)

    Product Code
    IZL
    Regulation Number
    892.1720
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MODEL SR-130-D PORTABLE DIGITAL X-RAY SYSTEM

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

    The Model SR-130-D Digital Portable X-Ray System is The Model OR Too E Portable Radiographic Applications.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter for a Portable Digital X-Ray System. It does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

    The letter primarily:

    • Confirms the FDA's review of the premarket notification.
    • States that the device is substantially equivalent to legally marketed predicate devices.
    • Outlines general regulatory requirements for the manufacturer.
    • Provides contact information for further inquiries.
    • Includes the "Indications For Use" statement.

    Therefore, I cannot provide the requested information based on the input text.

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    K Number
    K030494
    Device Name
    SR-130
    Manufacturer
    SOURCE-RAY, INC.
    Date Cleared
    2003-05-20

    (90 days)

    Product Code
    IZL
    Regulation Number
    892.1720
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SR-130

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

    The Model SR-130 Portable X-Ray System is intended for General Purpose Portable Radiographic Applications.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a portable X-ray system (SR-130). This type of letter does not contain details about acceptance criteria, device performance studies, or ground truth establishment.

    The letter is a regulatory document stating that the device has been found substantially equivalent to a legally marketed predicate device, allowing it to be marketed. It focuses on regulatory compliance, classification, and general controls, rather than detailed performance study results.

    Therefore, I cannot provide the requested information based on the input text. The document does not contain:

    1. A table of acceptance criteria and reported device performance.
    2. Sample sizes or data provenance for test sets.
    3. Number or qualifications of experts for ground truth.
    4. Adjudication methods.
    5. Information about MRMC comparative effectiveness studies or human reader improvement with AI.
    6. Results from standalone algorithm performance studies.
    7. The type of ground truth used.
    8. Sample size for the training set.
    9. How ground truth for the training set was established.
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