510(k) K162065 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Ultrasound System SONIMAGE HS1
| Applicant | Konica Minolta, Inc., Hino-Shi, JP |
| Decision | Substantially Equivalent, Oct 19, 2016 |
| Received | Jul 26, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162065
| 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: 1. A9RP, UDI: 04560141945463; 2. AAEU, UDI: 04560141946385; 3. A9RR, UDI: 04560141945470 Terminated |
IYN | None listed |
| Apr 24, 2017 | Konica Minolta, Inc. Diagnostics Ultrasound System
Ultrasounds System Sonimage HS1 Terminated |
IYN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.