510(k) K180084 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
Ultrasound System SONIMAGE MX1
| Applicant | Konica Minolta, Inc., Hino-Shi, JP |
| Decision | Substantially Equivalent, Feb 8, 2018 |
| Received | Jan 11, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180084
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.