510(k) K190314 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
Advanced Intelligent Volumetric Ultrasound System, Model AiVUS 1000
| Applicant | Mednovel Technology, Ltd., Milpitas CA, US |
| Decision | Substantially Equivalent, Oct 9, 2019 |
| Received | Feb 13, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190314
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.