510(k) K152577 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
ULTRASOUND SYSTEM SONIMAGE HS 1
| Applicant | Konica Minolta, Inc., Hino-Shi, JP |
| Decision | Substantially Equivalent, Oct 8, 2015 |
| Received | Sep 9, 2015 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K152577
| 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: A8WA, UDI: 04560141944534 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.