510(k) K252362 ยท QIH Automated Radiological Image Processing Software
GBrain MRI
| Applicant | Galileo Cds, Inc., Austin TX, US |
| Decision | Substantially Equivalent, Aug 22, 2025 |
| Received | Jul 29, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K252362
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.