510(k) K252539 ยท QIH Automated Radiological Image Processing Software
Tempus Pixel
| Applicant | Arterys, Inc., Chicago IL, US |
| Decision | Substantially Equivalent, Sep 3, 2025 |
| Received | Aug 12, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K252539
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.