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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-ime and accelerated images. The Heart Vista Workstation with the RTHawk application software is indicated for Cardiovascular MR (CMR) applications.

The HeartVista 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 HeartVista 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.

The HeartVista Workstation with the RTHawk application software is an accessory to 1.5T and 3.0T whole-body magnetic resonance systems. 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. No hardware modifications are required to be made to the MR system or console to support full functionality of the HeartVista Workstation with the RTHawk application software.

The HearlVista Workstation with the RTHawk application software temporarily controls the existing MR system to acquire MRI raw data and related information accordina to pulse sequence programs within the Workstation, Image reconstruction, post-processing, and image display are performed on the Workstation, independent of the MR system or console. No existing GE scanner functionality is removed or modified, and GE scans may be interleaved with HeartVista scans during the same patient exam.

The HeartVista Workstation with the RTHawk application software and dedicated hardware product intended to provide a platform for efficient real-lime MRI data acquisition, data transfer, image reconstructive scan control, and display of static and dynamic MR imaaing data.

The HeartVista Workstation consists of a stand-alone linux-based computer workstation, color monitor, keyboard and mouse. A private ethernet network connects the HeartVisia Workslation to the MR scanner computer. When not in use, the HeartVista Workslation 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 interface for 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.

The provided document describes the HeartVista Workstation with RTHawk application software and its 510(k) submission (K133848) for FDA clearance. The performance data section focuses on non-clinical and a brief mention of clinical tests for the device itself, rather than a study proving the device meets a specific set of acceptance criteria for a diagnostic task.

The document highlights the device's technical performance and safety, comparing it to a predicate device (GE Signa Excite 1.5T and 3.0T MR Systems, K041476) to establish substantial equivalence.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of "acceptance criteria" for a specific diagnostic task or a detailed "reported device performance" against those criteria in the way one might expect for an AI-powered diagnostic device. Instead, the acceptance is based on demonstrating substantial equivalence to a predicate MR system and compliance with recognized standards.

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