FDA-cleared K251029
Vista OS, Vista AI Scan, RTHawk
Vista AI, Inc.
Authorized purpose: Vista OS, Vista AI Scan, and RTHawk operate as accessories with compatible GE and Siemens 1.5T and 3T MR systems to acquire, reconstruct, display, and support technologist workflows for the labeled whole-body MR images.
- Modality
- MRI
- Anatomy
- Whole body; head; brain; cardiac; and other labeled MR anatomy
- Decision
- 2025-08-21