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510(k) Data Aggregation

    K Number
    K981404
    Device Name
    FUKUDA DENSHI ULTRASOUND SCANNERS MODELS UF-3500 AND UF-4500
    Manufacturer
    FUKUDA DENSHI USA, INC.
    Date Cleared
    1998-05-20

    (33 days)

    Product Code
    IYO
    Regulation Number
    892.1560
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K955543,K922208,K961459,K970901
    Why did this record match?
    Reference Devices :

    K955543, K922208

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

    Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Musculo-skeletal Conventional and Musculo-skeletal Superficial. Musculo-skeletal Superficial is defined as muscle, tendon, ligament, bursa, and other soft tissue in the vicinity of the shoulder, elbow, wrist, knee, and/or ankle.

    Device Description

    The Fukuda Denshi model UF-4500 (K022208) and the model UF-3500 (K955543) are general-purpose ultrasound systems that have been previously found to be substantially equivalent under the Food and Drug Administration's 510(k) process. These devices have not been changed or modified in any way. All software and hardware, all portions of the device that control the acoustic power out are unchanged. The addition of both conventional and musculoskeletal imaging as intended uses require no changes to the operating instructions.

    AI/ML Overview

    The provided text describes a 510(k) submission for adding new intended uses (conventional and superficial musculoskeletal imaging) to existing Fukuda Denshi ultrasound scanners (UF-3500 and UF-4500).

    Here's an analysis of the acceptance criteria and study information, based only on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance:

    The document doesn't explicitly state numerical acceptance criteria for diagnostic performance or reported performance metrics in a typical table format. The "Testing" section broadly concludes the device's capability.

    Acceptance Criteria CategorySpecific Criteria (from text)Reported Device Performance (from text)
    Acoustic Output LimitsRemains below maximums established for Track 1 devices by "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" (September 30, 1997).
    (Specific limits for Peripheral Vessel, Cardiac, Fetal Imaging & Other, Ophthalmic are provided in a table, e.g., ISPTA3
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