510(k) K170315 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Acuson SC2000 Diagnostic Ultrasound System
| Applicant | Siemens Medi Cal Solutions, Inc., Moutain View CA, US |
| Decision | Substantially Equivalent, Apr 4, 2017 |
| Received | Feb 1, 2017 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K170315
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 26, 2018 | Siemens Medical Solutions USA, Inc. ACUSON SC2000 Ultrasound System. The firm name on the label is Siemens Medical Solutions USA, Inc., Buffalo Grove, IL. Terminated |
IYN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.