K251029
- 510(k) number
- K251029
- Device name
- Vista OS, Vista AI Scan, RTHawk
- Applicant
- Vista AI, Inc. CA · US
- Product code
- LNH — System, Nuclear Magnetic Resonance Imaging
- Decision date
- 2025-08-21
- Date received
- 2025-04-02
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K251029.pdf
Official FDA record: K251029
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.