510(k) Report

Devices descending from K082781

35 later devices reach Oec 9900 Elite through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K140041Zen-7000,System,Fluroscopic X-Ray SystemGenoray Co., Ltd.20142—
+1K120613Oec 9900 EliteGe Healthcare Surgery GE Oec Medical Systems, Inc.2012187
+1K111551Oec (R) 9800, Oec (R) 9800 PlusGe Oec Medical Systems, Inc.2011129
+2K233380TRIDENT Mobile Fluoroscopy SystemDornier Medtech America20240—
+2K172180OSCAR 15Genoray Co., Ltd.20181—
+2K132027Oec 9800 PlusGe Oec Medical Systems, Inc.201468
+2K131423G-Arm Multiscan SystemBeijing East Whale Imaging Technology Co., Ltd.20135—
+2K123603Oec Brivo 865 Advance, Oec Brivo 785 Essential, and Oec Brivo 715 PrimeGe Healthcare Surgery GE Oec Medical Systems, Inc.201345
+2K122234Oec 9900 EliteGe Healthcare Surgery GE Oec Medical Systems, Inc.2012106
+3K251650Insight Enhanced™ DRF (EN-1002-01)Imaging Engineering, LLC20250—
+3K250010Extron 3; Extron 5; Extron 7DRTECH Corporation20251—
+3K230787Oscar 15 & Oscar 15iGenoray Co., Ltd.20230—
+3K183109ControlRad Trace Model 8Controlrad, Inc.20194—
+3K172700OEC OneGe Hualun Medical Systems Co., Ltd.20173—
+3K170752OEC EliteOec Medical Systems, Inc.201774
+3K151280MultiScan G-Arm SystemBeijing East Whale Imaging Technology Co., Ltd.20153—
+3K141672Digiarc 100AU+Beijing East Whale Imaging Technology Co., Ltd.20144—
+4K261413Extron 3;Extron 6DRTECH Corporation20260—
+4K251004Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M)Hefei Chimed Intelligent Machine Co., Ltd.20250—
+4K211782ControlRad Select Model Z, ControlRad Trace Model 8, ControlRad Trace Model 9Controlrad, Inc.20210—
+4K200663ControlRad Trace Model 9Controlrad, Inc.20203—
+4K182626OEC OneGe Hualun Medical Systems Co., Ltd.20182—
+4K171565OEC EliteGe Oec Medical Systems, Inc.201764
+4K160984MultiScan G-Arm SystemBeijing East Whale Imaging Technology Co., Ltd.20161—
+5K240828OEC One ASDGe Hualun Medical Systems Co., Ltd.20241—
+5K202431ControlRad Select Model ZControlrad, Inc.20202—
+5K172550OEC EliteGe Oec Medical Systems, Inc.201754
+5K163429B6Beijing East Whale Imaging Technology Co., Ltd.20170—
+6K253269OEC One CFDGe Hualun Medical Systems Co., Ltd.20250—
+6K213455ControlRad Select Model ZControlrad, Inc.20210—
+6K200218Digiscan FDXAllengers Medical Systems Limited20201—
+6K192819OEC EliteGe Oec Medical Systems, Inc.201924
+7K253296Digital C-ARM with 3DAllengers Medical Systems Limited20260—
+7K203346OEC 3DGe Oec Medical Systems, Inc.202113
+8K233669OEC 3DGe Oec Medical Systems, Inc.202402