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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 9 of 9 Results
510(K) Number: K053281
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Product Description
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FDA Recall
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iConnect Enterprise Archive when used with RadSuite. The firm name on the label is Merge Healthcare... 2 03/10/2017 Merge Healthcare, Inc.
Merge RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI. 2 02/09/2017 Merge Healthcare, Inc.
Merge RadSuite,f/k/a: Emageon Advanced Visualization , RadSuite versions 8.30.7.8, 8.30.7.9, 8.30.8,... 2 11/18/2016 Merge Healthcare, Inc.
RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI. 2 09/14/2016 Merge Healthcare, Inc.
Merge RadSuite software. Radiological image processing system. 2 09/02/2016 Merge Healthcare, Inc.
RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI. RadSuite provid... 2 08/29/2016 Merge Healthcare, Inc.
RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI. 2 08/23/2016 Merge Healthcare, Inc.
RadSuite, a picture archive and communications system. Model Numbers Versions 5.30.0, 5.30.1, 5.30.2... 2 02/10/2016 Merge Healthcare, Inc.
EVMS (Enterprise Visual Medical System); Picture archiving and communications system; Model Numbers:... 3 05/28/2008 Emageon
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