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510(k) Data Aggregation

    K Number
    K250469
    Device Name
    Accuro® 3S Needle Guide Kit
    Manufacturer
    Rivanna Medical, Inc.
    Date Cleared
    2025-06-13

    (115 days)

    Product Code
    ITX
    Regulation Number
    892.1570
    Why did this record match?
    Applicant Name (Manufacturer) :

    Rivanna Medical, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Accuro® 3S Needle Guide Kit is intended to be used with the Accuro® 3S diagnostic ultrasound imaging system. The Accuro® 3S Needle Guide Kit supports alignment of a needle with the ultrasound imaging plane to assist the healthcare professional in placing the tip of a needle relative to a specific anatomical structure. The elastic bands on the Patient Drape are intended to stabilize the positioning of the Accuro® 3S Needle Guide. The Accuro® 3S Probe Cover sheathes the transducer and isolates a needle insertion site from microbial and other contaminants.
    Device Description
    The Accuro® 3S Needle Guide Kit consists of the following single use sterile disposable components: Accuro® 3S Needle Guide with integrated probe cover, conductive ultrasound gel, and a patient drape with two integrated probe elastic bands. The kit components are assembled into a sterilized CSR Wrap then packaged in a sterile tray. The final kit is sterilized under ethylene oxide.
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    K Number
    K243937
    Device Name
    Accuro 3S
    Manufacturer
    Rivanna Medical, Inc.
    Date Cleared
    2025-05-23

    (154 days)

    Product Code
    IYO
    Regulation Number
    892.1560
    Why did this record match?
    Applicant Name (Manufacturer) :

    Rivanna Medical, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Accuro 3S is a diagnostic ultrasound imaging system for use by qualified and trained healthcare professionals. Accuro 3S is intended to be used in a hospital or medical clinic environment at the point of care. Accuro 3S supports B-mode imaging and a SpineNav-AI™ image processing software. Accuro 3S clinical applications include: musculoskeletal conventional and superficial, and guidance for needle or catheter placement. A typical examination using Accuro 3S is guidance of neuraxial anesthesia.
    Device Description
    The Accuro® 3S is an ultrasound imaging device intended for use by qualified and trained healthcare professionals in hospital or medical clinic environments. The device offers B-mode imaging and a SpineNav-AI™ image processing software. The Accuro 3S is a portable system with a small footprint that can be easily maneuvered within the intended use environment and at the point of care. The device features a touchscreen interface and articulated monitor arm to optimize viewing angle. An integrated battery pack allows the system to operate without wall power. Accuro 3S interfaces with healthcare IT networks to implement DICOM-based patient and image archival workflows, with image storage in an external PACS. The device utilizes a Dual-Array™ convex probe. SpineNav-AI is an automated software tool that utilizes machine learning technologies to facilitate workflows associated with musculoskeletal imaging assessments of the lumbar spine. The Accuro 3S Dual-Array probe comprises a side-by-side convex transducer array design. Each convex array has identical specifications: 64 elements, 3.5 – 4.0 MHz nominal center frequency, 480-micron pitch, and 50 mm radius of curvature.
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