510(k) K092954 ยท LLZ System, Image Processing, Radiological
CADSTREAM VERSION 5
| Applicant | Confirma, Inc., Bellevue WA, US |
| Decision | Substantially Equivalent, Nov 6, 2009 |
| Received | Sep 25, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K092954
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 30, 2016 | Merge Healthcare, Inc. CADstream software. The firm name on the label is Merge Healthcare, Hartland, WI. Terminated |
LLZ | None listed |
| Nov 1, 2012 | Merge Healthcare, Inc. CADstream software.
Product Usage:
CADstream is an image processing system designed to assist in the visualization, analysis, and reporting of magnetic resonance imaging (MRI) studies. CADstream als Terminated |
LLZ | None listed |
| Oct 19, 2011 | Merge Healthcare, Inc. CADstream software
Product Usage:
CADstream is an image processing system designed to assist in the visualization, analysis, and reporting of magnetic resonance imaging (MRI) studies. CADstream als Terminated |
LLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.