510(k) Report

Devices descending from K160620

2 later devices reach Visaris Vision® (Vision C, Vision U. Vision V, Vision X) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K193360Acuity SDR Standard, Acuity SDR Plus, Acuity FDR StandardRadmedix, LLC20201—
+2K231995AcuityUDRRadmedix, LLC20230—