510(k) K111804 ยท LLZ System, Image Processing, Radiological
INTELLISPACE PACS 4.X
| Applicant | Philips Healthcare Informatics, Inc., Foster City CA, US |
| Decision | Substantially Equivalent, Jul 28, 2011 |
| Received | Jun 27, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111804
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 19, 2019 | Philips Healthcare Informatics, Inc. IntelliSpace PACS 4.4, Product number 837507 - Product Usage: intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. Completed |
LLZ | None listed |
| Aug 16, 2014 | Philips Healthcare Informatics, Inc. Philips IntelliSpace PACS 4.4 image management systems performs digital image processing, measurement and communication and storage. Terminated |
LLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.