K250416
- 510(k) number
- K250416
- Device name
- GBrain MRI
- Applicant
- Galileo Cds, Inc. TX · US
- Product code
- QIH — Automated Radiological Image Processing Software
- Decision date
- 2025-04-11
- Date received
- 2025-02-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K250416.pdf
Official FDA record: K250416
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.