510(k) K253057 ยท QIH Automated Radiological Image Processing Software
AI-Rad Companion Brain MR
| Applicant | Siemens Healthcare GmbH, Erlangen, DE |
| Decision | Substantially Equivalent, Jan 22, 2026 |
| Received | Sep 22, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253057
No recall in the FDA data names this 510(k).
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