510(k) K153103 ยท LLZ System, Image Processing, Radiological
CARESTREAM Vue PACS
| Applicant | Carestream Health, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, Feb 12, 2016 |
| Received | Oct 26, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153103
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 20, 2024 | Philips Medical Systems Technologies Ltd. Vue PACS Diagnostic Viewer with Vue PACS client 12.1.5 to 12.2.8.454 software
Model Number: 1149418
Intended use is to provide completely scalable local and wide area PACS (Picture Archiving and Com Open, Classified |
LLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.