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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