510(k) K053281 ยท LLZ System, Image Processing, Radiological
EVMS (ENTERPRISE VISUAL MEDICAL SYSTEM SOFTWARE)
| Applicant | Emageon, Inc., Madison WI, US |
| Decision | Substantially Equivalent, Dec 7, 2005 |
| Received | Nov 25, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K053281
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 10, 2017 | Merge Healthcare, Inc. iConnect Enterprise Archive when used with RadSuite. The firm name on the label is Merge Healthcare. Terminated |
LMB | None listed |
| Feb 9, 2017 | Merge Healthcare, Inc. Merge RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI. Terminated |
LLZ | None listed |
| Sep 2, 2016 | Merge Healthcare, Inc. Merge RadSuite software. Radiological image processing system. Terminated |
LLZ | None listed |
| Aug 23, 2016 | Merge Healthcare, Inc. RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI. Terminated |
LLZ | None listed |
| Jul 14, 2016 | Merge Healthcare, Inc. Merge RadSuite,f/k/a: Emageon Advanced Visualization , RadSuite versions 8.30.7.8, 8.30.7.9, 8.30.8, and 8.31.
Advanced Visualization (Image Viewing) includes: Full featured 2D imaging, 3D surface and Terminated |
LLZ | None listed |
| Jan 30, 2016 | Merge Healthcare, Inc. RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI.
RadSuite provides a means to distribute, display, and store diagnostic-quality medical images in electronic format. Terminated |
LLZ | None listed |
| Dec 17, 2015 | Merge Healthcare, Inc. RadSuite, a picture archive and communications system. Model Numbers Versions 5.30.0, 5.30.1, 5.30.2, 5.30.2 SB0344, 5.30.3, 5.30.4, 5.30.4 HF0418E, 5.30.5, 5.30.5 HF0404E, 5.30.5 HF0413E, 5.30.5 HF39 Terminated |
LLZ | None listed |
| May 6, 2013 | Merge Healthcare, Inc. RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI. Terminated |
LLZ | None listed |
| May 28, 2008 | Emageon EVMS (Enterprise Visual Medical System); Picture archiving and communications system; Model Numbers: 5.30.4, 5.30.5, 5.30.6, 5.30.7, 5.40.0 and 7.0.0.1. Emageon, Inc., Hartland, WI 53029. Terminated |
LLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.