510(k) K983447 ยท LMB Device, Digital Image Storage, Radiological
WISE (II) IMAGE MANAGEMENT SYSTEM
| Applicant | Sectra-Imtec AB, Plano TX, US |
| Decision | Substantially Equivalent, Oct 29, 1998 |
| Received | Sep 30, 1998 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K983447
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 8, 2005 | Philips Medical Systems Sales & Service Region No. America Easy Access Image Management System with CL.Net. Terminated |
LMB | None listed |
| Sep 12, 2003 | Philips Medical Systems Easy Access PACS System with software Release 5, 6.2, or 7.2 Terminated |
LLZ | None listed |
| Aug 12, 2003 | Philips Medical Systems Easy Access
Software releases 1.1, 5.2, 6.2 & 7.2 Terminated |
LLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.