510(k) Report

Devices descending from K191310

2 later devices reach Insight Essentials DRF Digital Imaging System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K200396Insight Enhanced DRF Digital Imaging SystemImaging Engineering, LLC20201—
+2K251650Insight Enhanced™ DRF (EN-1002-01)Imaging Engineering, LLC20250—