510(k) K173981 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound System
| Applicant | Siemens Medical Solutions USA, Inc. Ultrasound Group, Moutain View CA, US |
| Decision | Substantially Equivalent, Feb 2, 2018 |
| Received | Dec 29, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K173981
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 28, 2019 | Siemens Medical Solutions USA, Inc. ACUSON NX2 Diagnostic Ultrasound System, Model # 11284381, RX Only, Siemens Medical Solutions, containing software version VA10A, VA10B, VA11A, VA11B;
UDI # 04056869030005
The ACUSON NX2 diagnostic Open, Classified |
IYN | None listed |
| Jan 28, 2019 | Siemens Medical Solutions USA, Inc. ACUSON NX2 Elite Diagnostic Ultrasound System, Model # 11284500, RX Only, Siemens Medical Solutions, containing software version VA10A, VA10B, VA11A, VA11B; UDI # 04056869050775
The ACUSON NX2 diagn Open, Classified |
IYN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.