510(k) K152469 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
ACUSON NX3 Elite / NX3 Diagnostic Ultrasound System
| Applicant | Siemens Medical Solutions, Inc., Ultrasound Division, Moutain View CA, US |
| Decision | Substantially Equivalent, Sep 21, 2015 |
| Received | Aug 31, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152469
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 28, 2019 | Siemens Medical Solutions USA, Inc. ACUSON NX3 Diagnostic Ultrasound System, Model # 11235612, RX Only, Siemens Medical Solutions, containing software versions: VA10A, VA10B, VA10C, VA10D, VA10E, VA10F, VB20A, and VB20B;
UDI # 04056 Open, Classified |
IYN | None listed |
| Jan 28, 2019 | Siemens Medical Solutions USA, Inc. ACUSON NX3 Elite Diagnostic Ultrasound System, Model # 11235411, RX Only, Siemens Medical Solutions, containing software versions: VA10A, VA10B, VA10C, VA10D, VA10E, VA10F, VB20A, and VB20B;
UDI # Open, Classified |
IYN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.