Vista OS, Vista AI Scan, RTHawk

Vista OS is software that operates as an accessory to 1.5T and 3.0T MRI scanners from GE Healthcare and Siemens. It runs on a standalone Linux workstation connected via Ethernet to the MRI console and enables acquisition, reconstruction, and display of static and dynamic cross-sectional MR images of the entire body to assist physicians in diagnosis.

Vista OS adds several AI-based automation features not in the predicate: automatic motion artifact detection in cardiac cine imaging, detection of ungateable ECG waveforms, neural-network image denoising for cardiac images, and new localizer apps for brain and prostate with automatic prescription. It also adds a Frequency Scout App, Cine Flow Calibration App, an improved inversion pulse for cardiac T1 mapping, and support for newer GE software versions (HD16, SV25, MR30.1) and Ubuntu 24.04. All AI outputs remain under operator control; no clinical decisions are automated.

IEC 60601-2-33:2022-08 (MR equipment safety), IEC 60601-1:2020 (general medical device safety, PEMS), MS1-2008 (SNR determination), MS3-2008 (image uniformity), MS4-2010 (acoustic noise), MS8-2016 (SAR characterization), NEMA PS3.1-3.20 (DICOM), and ISO 14971:2019 (risk management).

Vista OS shares the same intended use, indications, scanner compatibility (1.5T/3.0T GE and Siemens), and functional architecture as the predicate K212233. Both acquire and display MR images via a parallel workstation with no hardware modification to the scanner. The new AI features are limited to scan optimization tasks (plane localization, artifact detection, parameter suggestions) where the technologist retains final control, and clinical verification testing on diverse patient populations demonstrated each AI model meets or exceeds predefined acceptance criteria. Safety parameters (SAR, dB/dt, operating modes) remain unchanged. The additions enhance workflow efficiency without altering the fundamental diagnostic capability or safety profile.