510(k) K191504 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
PowerDR
| Applicant | Radiology Information Systems, Inc., Dulles VA, US |
| Decision | Substantially Equivalent, Aug 16, 2019 |
| Received | Jun 6, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191504
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.