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510(k) Data Aggregation

    K Number
    K142997
    Device Name
    RTHawk, HeartVista Workstation with RTHawk
    Manufacturer
    HEARTVISTA, INC.
    Date Cleared
    2014-12-17

    (68 days)

    Product Code
    LNH
    Regulation Number
    892.1000
    Type
    Special
    Panel
    Radiology
    Reference & Predicate Devices
    K133848
    Predicate For
    K153740
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The HeartVista Workstation with the RTHawk application software is an accessory to 1.5T and 3.0T whole-body magnetic resonance diagnostic devices (MRDD or MR). The HeartVista Workstation with the RTHawk application software is intended to operate alongside, and in parallel with, the existing MR console to acquire real-time and accelerated images. The HeartVista Workstation with the RTHawk application software is indicated for Cardiovascular MR (CMR) applications.

    The Heart Vista Workstation with the RTHawk application software produces static and dynamic transverse, coronal, sagittal, and oblique cross-sectional images that display the internal structures and/or functions of the entire body. The images produced reflect the spatial distribution of nuclei exhibiting magnetic resonance. The magnetic resonance properties that determine image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2) and flow. When interpreted by a trained physician, these images provide information that may assist in the determination of a diagnosis.

    The Heart Vista Workstation with the RTHawk application software is intended for use as an accessory to the following OEM, MRI system, and software release versions:

    · GE Healthcare (GEHC) Signa HDxt 1.5T, 3.0T. Software versions 15 and 16

    • · GE Healthcare (GEHC) DVMR 1.5T, 3.0T. Software version 24
    Device Description

    The HeartVista Workstation with RTHawk application software are a software and dedicated hardware product intended to provide a platform for efficient real-time MRI data acquisition, data transfer, image reconstruction, and interactive scan control and display of static and dynamic MR imaging data.

    The HeartVista Workstation consists of a stand-alone linux-based computer workstation, color monitor, keyboard and mouse. It is designed to operate alongside, and in parallel with, the existing MR console with no hardware modifications required to be made to the MR system or console. A private ethernet network connects the HeartVista Workstation to the MR scanner computer. When not in use, the HeartVista Workstation may be detached from the MR scanner with no detrimental, residual impact upon MR scanner function, operation, or throughput.

    RTHawk is a linux operating system-level software application that is intended to control the MR scanner, acquiring high quality, real-time MRI image data and performing post-processing. The RTHawk software includes optimized image acquisition applications, a pipelined raw data image reconstruction engine, a rich graphical user interactive scan control, real-time adjustment of pulse sequence parameters, and display of reconstructed images, and drivers and protocols for communications with, and control of, the OEM MR scanner console.

    RTHawk applications ("apps") support real-time interactive imaging, high-resolution imaging, and system tuning and shimming calibration modules. RTHawk apps are currently optimized for cardiovascular MR (CMR) imaging and measurements.

    AI/ML Overview

    The provided text does not contain detailed acceptance criteria or a study that explicitly demonstrates the device meets specific performance criteria in terms of accuracy, sensitivity, or specificity. The document is primarily a 510(k) summary for the HeartVista Workstation with RTHawk, focusing on its substantial equivalence to a predicate device and adherence to recognized consensus standards.

    However, based on the non-clinical tests and performance data discussion, we can infer some aspects relevant to performance.

    Here's an attempt to structure the information based on the request, acknowledging the limitations of the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria (Inferred)Reported Device Performance
    Image Quality and Diagnostic Accuracy Equivalence: Images acquired with RTHawk should demonstrate comparable image quality and diagnostic accuracy to images acquired using equivalent pulse sequences and post-processing from the predicate device. Where direct comparison is not possible, RTHawk images should be diagnostically acceptable based on radiologist expertise.Clinical images acquired with RTHawk were compared to images from the predicate device (where possible, using equivalent pulse sequences). Images from both devices were evaluated and rated on the basis of diagnostic accuracy and image quality. Where no direct comparison, RTHawk images were evaluated directly based upon radiologist expertise. The conclusion states substantial equivalence.
    Signal-to-Noise Ratio (SNR): Meeting standards for SNR in diagnostic MRI.Performance testing included SNR, conforming to MS1-2008.
    Image Uniformity: Meeting standards for image uniformity in diagnostic MRI.Performance testing included uniformity, conforming to MS3-2008.
    Safety Parameters (SAR, dB/dt, Acoustic Noise): Compliance with IEC 60601-2-33 (2010-03) and specific limits for SAR (
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