510(k) K151060 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
Ultrasound System SONIMAGE HS1
| Applicant | Konica Minolta, Inc., Hino-Shi, JP |
| Decision | Substantially Equivalent, Jun 5, 2015 |
| Received | Apr 20, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K151060
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 4, 2017 | Konica Minolta Medical Imaging USA, Inc. Sonimage HS1 Ultrasound Kit AC adapter, Product Number: A8AR, UDI: 04560141941588 Terminated |
IYN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.