510(k) K152573 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
4Sight
| Applicant | Accutome, Inc., Malvern PA, US |
| Decision | Substantially Equivalent, Nov 25, 2015 |
| Received | Sep 9, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152573
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.