510(k) K063267 ยท LLZ System, Image Processing, Radiological
ISITE PACS, V 4. X
| Applicant | Stentor Inc., A Philips Medical Systems Co., Brisbane CA, US |
| Decision | Substantially Equivalent, Nov 9, 2006 |
| Received | Oct 30, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K063267
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 4, 2011 | Philips Medical Systems iSite PACS with Advanced Visualization Tools (AVT) R7.4V6L1, Versions: 3.6.87, 3.6.92, 4.1.87, and 4.1.92;
Product is manufactured and distributed by Philips Medical Systems, Foster City, CA
iSite PA Terminated |
LLC | None listed |
| Jan 30, 2009 | Philips Healthcare Informatics, Inc. iSite PACS (Picture Archiving and Communications System) Versions 4.1.x up to and including 4.1.51.3, manufactured by Philips Healthcare Informatics, Foster City, CA.
Device is an image management sys Terminated |
LLZ | None listed |
| Oct 28, 2008 | Philips Healthcare Informatics, Inc. iSite PACS (Picture Archiving and Communication System), software versions 3.6.28.x and 4.1.x.
The product is an image management system (software package) used with general purpose computing hardwar Terminated |
LLZ | None listed |
| Aug 16, 2008 | Philips Healthcare Informatics, Inc. Philips Medical Systems iSite PACS (Picture Archiving and Communications Systems) version 4.1.17.0 - Radiology Image management system. Terminated |
LLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.