510(k) K983401 ยท LLZ System, Image Processing, Radiological
FRAMEWAVE WEB
| Applicant | Ml Strategies, Inc., Boston MA, US |
| Decision | Substantially Equivalent, Dec 15, 1998 |
| Received | Sep 28, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K983401
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 28, 2011 | Merge Healthcare, Inc. Fusion Workstation.; Indicated for the transmission and review of radiological images. Terminated |
LLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.