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U.S. Department of Health and Human Services

Medical Device Recalls

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1 to 3 of 3 Results
510(K) Number: K121739
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iVue with Normative Database, Device Listing Number D185549. Product Usage: The iVue (K121739) i... 2 10/04/2017 Optovue, Inc.
iVue and iVue 500 (now called iScan) OCT systems with software version 2016.0.0.127 (USA only) and 2... 2 08/14/2017 Optovue, Inc.
Optovue iVue with Normative Database (NDB) with Software Version 3.0 and 3.1. Intended for in viv... 3 05/31/2013 Optovue, Inc.