510(k) K230977 ยท QIH Automated Radiological Image Processing Software
SIS System
| Applicant | Surgical Information Sciences, Inc., Edina MN, US |
| Decision | Substantially Equivalent, May 2, 2023 |
| Received | Apr 5, 2023 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K230977
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.