510(k) K231955 · QIH Automated Radiological Image Processing Software
aprevo® Digital Segmentation
| Applicant | Carlsmed, Inc., Carlsbad CA, US |
| Decision | Substantially Equivalent, Nov 3, 2023 |
| Received | Jul 3, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K231955
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.