510(k) Report

Devices descending from K052908

3 later devices reach Intraredx Nir Imaging System, Model MC-5 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K093510Lumenvu Catheter Guidance SystemSonosite,Inc.20100—
+1K072932Infraredix Nir Imaging System, Gen. 1.0, Model MC-5Infraredx, Inc.20081—
+2K093993Lipiscan Ivus Imaging System Model Nirs-MC7-70Infraredx, Inc.20100—