510(k) K040468 ยท LLZ System, Image Processing, Radiological
CEDARA I-SOFTVIEW AND CEDARA I-READMAMMO
| Applicant | Cedara Software Corp., Mississauga Ontario, CA |
| Decision | Substantially Equivalent, Apr 23, 2004 |
| Received | Feb 24, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K040468
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 14, 2014 | GE Healthcare It Merge Mammo is a multi-modality, vendor-neutral digital mammography workstation that enables imaging centers to use a single workstation to display and read images from different vendors and different Terminated |
LLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.