510(k) K142197 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
ULTRASOUND SYSTEM SONIMAGE HS1, LINEAR PROBE L18-4, CONVEX PROBE C5-2
| Applicant | Konica Minolta, Inc., Hino-Shi, JP |
| Decision | Substantially Equivalent, Nov 21, 2014 |
| Received | Aug 11, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K142197
| 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: A7AP, UDI: 04560141940031 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.