510(k) K092915 ยท LLZ System, Image Processing, Radiological
CEDARA WEBACCESS, MODEL: 2.4
| Applicant | Cedara Software Corp., Mississauga Ontario, CA |
| Decision | Substantially Equivalent, Jun 23, 2010 |
| Received | Sep 22, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K092915
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 24, 2017 | Merge Healthcare, Inc. Merge OrthoPACS software. The firm name on the label is Merge Healthcare, Hartland, WI. Terminated |
LLZ | None listed |
| May 25, 2016 | Merge Healthcare, Inc. iConnect Access software. The firm name on the label is Merge Healthcare, Hartland, WI. Terminated |
LLZ | None listed |
| Jan 30, 2016 | Merge Healthcare, Inc. iConnect Access used with Merge PACS software provides medical specialists with access to diagnostic quality images, reports, and various types of patient data over conventional TCP/IP (e.g., internet Terminated |
LLZ | None listed |
| Jan 30, 2016 | Merge Healthcare, Inc. iConnect Access used with Ortho PACS software provides medical specialists with access to diagnostic quality images, reports, and various types of patient data over conventional TCP/IP (e.g., internet Terminated |
LLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.