510(k) K033825 ยท LLZ System, Image Processing, Radiological
ORTHOPACS
| Applicant | Etrauma.Com Corp., Hopkonton MA, US |
| Decision | Substantially Equivalent, Feb 2, 2004 |
| Received | Dec 10, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K033825
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 11, 2016 | Merge Healthcare, Inc. Merge OfficePACS software. The firm name on the label is Merge Healthcare, Heartland, WI. Terminated |
LLZ | None listed |
| Jul 8, 2016 | Merge Healthcare, Inc. Merge OfficePACS software. The firm name on the label is Merge Healthcare, Hartland, WI.
OfficePACS is intended for the manipulation and displaying of medical images by a suitable licensed and qualif 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.