510(k) K123420 ยท LLZ System, Image Processing, Radiological
SYNGO, BREAST CARE
| Applicant | Siemens Medical Solutions USA, Inc., Mavern PA, US |
| Decision | Substantially Equivalent, Feb 1, 2013 |
| Received | Nov 6, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123420
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 6, 2016 | Siemens Medical Solutions USA, Inc SYNGO Breast Care, visualization and image enhancement tools to aid radiologist in the review of digital Mammography images and tomosynthesis datasets. Terminated |
LLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.