510(k) K162221 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
ACUSON SC2000 Diagnostic Ultrasound System
| Applicant | Siemens Medical Solutions Inc. Ultrasound Group, Moutain View CA, US |
| Decision | Substantially Equivalent, Sep 6, 2016 |
| Received | Aug 8, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K162221
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 26, 2018 | Siemens Medical Solutions USA, Inc. ACUSON SC2000 Ultrasound System
Product Usage:
The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Terminated |
IYN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.