510(k) K100094 ยท LLZ System, Image Processing, Radiological
CARESTREAM IMAGE SUITE
| Applicant | Carestream Heatlh, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, Mar 11, 2010 |
| Received | Jan 13, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100094
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 2, 2016 | Carestream Health Inc CARESTREAM Image Suite V3: MINI-PACS/F IMG ST/CLASSIC: REF/Catalog # 1036490; MINI-PACS/F IMG ST/POC&VITA: REF/Catalog # 1036508; MINI-PACS/F IMG ST/CLASSIC/INDIA: REF/Catalog # 1036417; MINI-PACS/F Terminated |
LLZ | None listed |
| May 2, 2016 | Carestream Health Inc CARESTREAM Image Suite V4; Image Suite V4: DICOM STORE SCP: REF/Catalog # 1056191, DICOM STORE SCP/FOR IMAGE SUITE V4: REF/Catalog # 6566988; Image Suite V4 Bundles: IMAGESUITE STANDALONE PACS: REF/ Terminated |
LLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.