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510(k) Data Aggregation

    K Number
    K050167
    Device Name
    CHISON 600M WITH C60 CONVEX PROBE, L700 LINEAR PROBE
    Manufacturer
    CHISON MEDICAL IMAGING CO., LTD.
    Date Cleared
    2005-02-08

    (13 days)

    Product Code
    IYO
    Regulation Number
    892.1560
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The CHISON 600M is intended for use with the following transducers: Convex Array C60, Linear Array L700, and Micro-convex Array C14. The clinical applications for the CHISON 600M with the Convex Array C60 transducer include Fetal, Abdominal, and Cardiac imaging in B, M, and Combined (B/M) modes. The clinical applications for the CHISON 600M with the Linear Array L700 transducer include Pediatric, Small Organ, Peripheral Vascular, and Musculo-skeletal imaging in B, M, and Combined (B/M) modes. Small organs include: thyroid, parathyroid, parotid, submaxillary gland, and Breast. The clinical application for the CHISON 600M with the Micro-convex Array C14 transducer is Transvaginal imaging in B, M, and Combined (B/M) modes.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) premarket notification from the FDA for a diagnostic ultrasound system, the CHISON 600M, and its associated transducers. It does not contain information about acceptance criteria or a study proving the device meets those criteria.

    The core of the provided text is the FDA's decision letter for the CHISON 600M ultrasound system, indicating that the device is substantially equivalent to legally marketed predicate devices. This letter also outlines regulatory compliance requirements and specific conditions for marketing, such as submitting a post-clearance special report with acoustic output measurements.

    The "Indications for Use" forms for the main device and its transducers (Convex Array C60, Linear Array L700, Micro-convex Array C14) list the clinical applications (e.g., Fetal, Abdominal, Cardiac, Small Organ, Peripheral Vascular) and modes of operation (e.g., B-mode, M-mode). The "N" in these tables indicates a "new indication" for that specific application and mode.

    Therefore, I cannot provide the requested information because the document does not describe acceptance criteria for performance, nor does it detail a study that proves the device meets such criteria. It is a regulatory approval document based on substantial equivalence to existing devices, not a performance study report.

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