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510(k) Data Aggregation

    K Number
    K982498
    Device Name
    DIAGNOSTIC ULTRASOUND SYSTEM
    Manufacturer
    VOLUMETRICS MEDICAL IMAGING, INC.
    Date Cleared
    1998-08-07

    (21 days)

    Product Code
    IYN
    Regulation Number
    892.1550
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K963863,K952551
    Predicate For
    K992378
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Diagnostic Ultrasound
    Fetal, Abdominal, Pediatric, Small Organ (Testes, adult female breast, and thyroid), Neonatal Cephalic, Cardiac, Peripheral Vascular

    Device Description

    Model 1.0 Diagnostic Ultrasound System

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for a diagnostic ultrasound system, Model 1.0, and its transducers (214U and 218PA). It primarily focuses on the regulatory clearance for the device's intended uses, comparing it to legally marketed predicate devices.

    This document does NOT contain information about acceptance criteria, device performance, study details (like sample size, data provenance, expert ground truth, or adjudication methods), or any comparative effectiveness studies (MRMC) or standalone algorithm performance studies.

    The "Indications for Use Form" tables (pages 2-4) list various clinical applications and the modes of operation available for the Model 1.0 system and its transducers. "P" indicates a previously cleared indication, and "N" indicates a new indication (for the system or transducer). "E" means "Added under Appendix E," suggesting an expanded indication.

    Therefore, I cannot provide the requested information. The document serves as an FDA clearance letter and the associated intended use statements, not a detailed technical report on a study proving device performance against acceptance criteria.

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