510(k) K042292 ยท LLZ System, Image Processing, Radiological
ISITE PACS
| Applicant | Stentor, Inc., Brisbane CA, US |
| Decision | Substantially Equivalent, Sep 8, 2004 |
| Received | Aug 24, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042292
| 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 |
| 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 |
| Sep 18, 2008 | Philips Healthcare Informatics, Inc. Philips Healthcare Informatics iSite PACS (Picture Archiving and Communications System), version 3.5.x
The system is a software package used with general purpose computing hardware to acquire, store, Terminated |
LLZ | None listed |
| Aug 16, 2008 | Philips Healthcare Informatics, Inc. Philips Medical Systems iSite PACS (Picture Archiving and Communications Systems) version 3.6.28.0 - Radiology Image management system. Terminated |
LLZ | None listed |
| May 8, 2008 | Philips Healthcare Informatics, Inc. iSite PACS image management system; Picture Archiving and Communications System; Radiology software package, Philips Healthcare Informatics, Foster City, CA 94404. Terminated |
LLZ | None listed |
| Mar 13, 2007 | Stentor Inc A Phillips Medical Systems Co. The iSight PACS (picture archiving and communications system) a software package used with general purpose computer hardware to acquire, store, distribute, process, and display images/associated data Terminated |
LLZ | None listed |
| Jan 18, 2006 | Stentor Inc ''iSite'' PowerScribe/iSite Integration, Picture Archiving and Communication System, software version 3.3 Terminated |
LLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.