510(k) K022788 ยท LLZ System, Image Processing, Radiological
PHILIPS HARMONY RELEASE 1
| Applicant | Philips Medical Systems North America Co., Bothell WA, US |
| Decision | Substantially Equivalent, Oct 25, 2002 |
| Received | Aug 22, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K022788
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 18, 2005 | Philips Medical Systems Sales & Service Region No. America Xcelera R1.2 Cardiology image and information management solution software. Terminated |
LLZ | None listed |
| Jul 20, 2004 | Philips Medical Systems Sales & Service Region No. America Xcelera System, image processing, radiological. Terminated |
LLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.