510(k) K103385 ยท LLZ System, Image Processing, Radiological
SECURVIEW DX DIAGNOSTIC WORKSTATION
| Applicant | Hologic, Inc., Danbury CT, US |
| Decision | Substantially Equivalent, Feb 2, 2011 |
| Received | Nov 18, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K103385
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 5, 2012 | Hologic, Inc. Hologics SecurView DX workstation, software version 7.3.0
intended for viewing mammography images and other imaging modalities.
SecurView DX is intended for selection, display, manipulation, filing Terminated |
LLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.