510(k) Report

Devices descending from K111551

12 later devices reach Oec (R) 9800, Oec (R) 9800 Plus through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K132027Oec 9800 PlusGe Oec Medical Systems, Inc.201468
+1K123603Oec Brivo 865 Advance, Oec Brivo 785 Essential, and Oec Brivo 715 PrimeGe Healthcare Surgery GE Oec Medical Systems, Inc.201345
+2K251650Insight Enhanced™ DRF (EN-1002-01)Imaging Engineering, LLC20250—
+2K183109ControlRad Trace Model 8Controlrad, Inc.20194—
+2K172700OEC OneGe Hualun Medical Systems Co., Ltd.20173—
+3K211782ControlRad Select Model Z, ControlRad Trace Model 8, ControlRad Trace Model 9Controlrad, Inc.20210—
+3K200663ControlRad Trace Model 9Controlrad, Inc.20203—
+3K182626OEC OneGe Hualun Medical Systems Co., Ltd.20182—
+4K240828OEC One ASDGe Hualun Medical Systems Co., Ltd.20241—
+4K202431ControlRad Select Model ZControlrad, Inc.20202—
+5K253269OEC One CFDGe Hualun Medical Systems Co., Ltd.20250—
+5K213455ControlRad Select Model ZControlrad, Inc.20210—