510(k) Report

Devices descending from K132027

6 later devices reach Oec 9800 Plus through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251650Insight Enhanced™ DRF (EN-1002-01)Imaging Engineering, LLC20250—
+1K183109ControlRad Trace Model 8Controlrad, Inc.20194—
+2K211782ControlRad Select Model Z, ControlRad Trace Model 8, ControlRad Trace Model 9Controlrad, Inc.20210—
+2K200663ControlRad Trace Model 9Controlrad, Inc.20203—
+3K202431ControlRad Select Model ZControlrad, Inc.20202—
+4K213455ControlRad Select Model ZControlrad, Inc.20210—