RTHawk, HeartVista Cardiac Package
HeartVista, Inc.The RTHawk HeartVista Cardiac Package is an advanced software system that works with 1.5T and 3.0T MRI scanners to acquire and display real-time and conventional cardiovascular magnetic resonance images. It enables clinicians to obtain detailed heart images quickly and accurately, incorporating automated tools to optimize cardiac scans and improve patient imaging workflows.
Intended Use
RTHawk is an accessory to 1.5T and 3.0T whole-body magnetic resonance diagnostic devices (MRDD or MR). It is intended to operate alongside, and in parallel with, the existing MR console to acquire traditional, real-time and accelerated images. The HeartVista Cardiac Package is a collection of RTHawk Apps designed to acquire, reconstruct and display cardiovascular MR (CMR) images.
Technology
RTHawk is a Linux-based software system functioning as an accessory to 1.5T and 3.0T MRI systems. It runs on a separate workstation connected via a private ethernet network to the MR scanner. The system acquires MR raw data in real-time, performs image reconstruction with efficient spiral acquisition techniques and advanced pipelines, and provides an interactive user interface for scan control and image display. It supports real-time modifications of scan parameters, automation tools, and several cardiac-specific imaging apps with features like myocardial segmentation and artifact detection.
Performance
The device underwent extensive testing including code reviews, design reviews, unit and integration testing, verification and validation testing, and safety testing such as SAR, dB/dt and acoustic noise measurements. It complies with relevant FDA recognized standards including IEC 60601-2-33 for MRI safety, SNR and image uniformity standards, and ISO 14971 for risk management. Performance testing demonstrated its capability to produce high-quality cardiovascular MR images reliably.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/23/2018
10 months - 2
FDA Approval
10/18/2019
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