510(k) Report

Devices descending from K021049

76 later devices reach Oec 9800 Plus Digital Mobile Imaging System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K121303Mobile C-ArmCanon Inc. -Medical Equipment Group20120—
+1K103425Zen-7000, Fluoroscopic X-Ray SystemGenoray America, Inc.20113—
+1K061203Ziehm Vision R Digital Mobile Imaging SystemZiehm Imaging, Inc.2006184
+1K041932Oec Olympus Fluoroscopic Imaging SystemGe Oec Medical Systems, Inc.2004407
+1K032761KMC-950 C-Arm Mobile SystemUnited Radiology Systems, Inc.200414—
+1K022114ImperiumElmstech, Inc.200215—
+2K200022FLUSION-9001, Fluoroscopic C-arm Mobile X-ray SystemLivermoretech, Inc.20200—
+2K163140SPINEL 12HD Interventional Fluoroscopic Mobile X-ray SystemGemss Medical Systems Co., Ltd.20170—
+2K160279ANYVIEW-500R Fluoroscopic Mobile X-Ray SystemEcotron Co., Ltd.20169—
+2K160065GEMSS Medical System Surgical Mobile Fluoroscopic X-ray SystemGemss Medical Systems Co., Ltd.20160—
+2K140041Zen-7000,System,Fluroscopic X-Ray SystemGenoray Co., Ltd.20142—
+2K132289Gemss Medical Systems Surgical Mobile Fluoroscopic X-Ray SystemGemss Medical Systems Co., Ltd.20140—
+2K083545Ziehm Vision RFDZiehm Imaging, Inc.2009173
+2K082781Oec 9900 EliteGe Healthcare Surgery2009354
+2K073543Oec 9900 EliteGe Oec Medical Systems2008385
+2K0619539900 Plus Mobile Fluoroscopy System with 3D and Navigation OptionsGe Oec Medical Systems200601
+3K191503MobileRay Pulse SE Digital Imaging SystemPortavision Medical, LLC20197—
+3K180473ANYVIEW DR SERIES FPD Fluoroscopic Mobile C-arm ANYVIEW-240DR, ANYVIEW-320DR…Ecotron Co., Ltd.20180—
+3K172180OSCAR 15Genoray Co., Ltd.20181—
+3K132904Ziehm Vision RFDZiehm Imaging GmbH2013161
+3K120613Oec 9900 EliteGe Healthcare Surgery GE Oec Medical Systems, Inc.2012187
+3K111551Oec (R) 9800, Oec (R) 9800 PlusGe Oec Medical Systems, Inc.2011129
+3K092713Spectre Wireless Encrypted Footswitch and Hand Switch SystemTransamerican Medical Imaging201001
+3K083725Radpro IonVirtual Imaging, Inc.20090—
+4K233380TRIDENT Mobile Fluoroscopy SystemDornier Medtech America20240—
+4K230787Oscar 15 & Oscar 15iGenoray Co., Ltd.20230—
+4K210469Insight Agile DRFImaging Engineering, LLC20211—
+4K211191Virtual C DRF Digital Imaging SystemPortavision Medical, LLC20215—
+4K203428Ziehm Vision RFDZiehm Imaging GmbH20213—
+4K200218Digiscan FDXAllengers Medical Systems Limited20201—
+4K142740Ziehm Vision RFD 3DZiehm Imaging GmbH2015101
+4K132027Oec 9800 PlusGe Oec Medical Systems, Inc.201468
+4K131423G-Arm Multiscan SystemBeijing East Whale Imaging Technology Co., Ltd.20135—
+4K123603Oec Brivo 865 Advance, Oec Brivo 785 Essential, and Oec Brivo 715 PrimeGe Healthcare Surgery GE Oec Medical Systems, Inc.201345
+4K122234Oec 9900 EliteGe Healthcare Surgery GE Oec Medical Systems, Inc.2012106
+5K253296Digital C-ARM with 3DAllengers Medical Systems Limited20260—
+5K251650Insight Enhanced™ DRF (EN-1002-01)Imaging Engineering, LLC20250—
+5K250010Extron 3; Extron 5; Extron 7DRTECH Corporation20251—
+5K242731MasteRad MiniX Mobile Digital Imaging System (Mini-X)Medicatech USA, Inc.20250—
+5K241567MC2 Portable X-ray SystemOxos Medical20241—
+5K231692Ziehm Vision RFDZiehm Imaging GmbH20232—
+5K212523VFSS Pro Mobile Digital Imaging SystemImagexray, LLC20211—
+5K212557Virtual C DRF-NEO Digital Imaging SystemPortavision Medical, LLC20211—
+5K203281Mobile ImagingRing System, IRm, Loop-X Mobile Imaging Robot, Loop-XMedphoton GmbH20201—
+5K202360Ziehm Vision RFD 3DZiehm Imaging GmbH20204—
+5K190064nView system 1Nview Medical, Inc.20192—
+5K183109ControlRad Trace Model 8Controlrad, Inc.20194—
+5K172700OEC OneGe Hualun Medical Systems Co., Ltd.20173—
+5K170752OEC EliteOec Medical Systems, Inc.201774
+5K151280MultiScan G-Arm SystemBeijing East Whale Imaging Technology Co., Ltd.20153—
+5K141672Digiarc 100AU+Beijing East Whale Imaging Technology Co., Ltd.20144—
+6K261413Extron 3;Extron 6DRTECH Corporation20260—
+6K252068MC2 Portable X-ray SystemOxos Medical202501
+6K251004Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M)Hefei Chimed Intelligent Machine Co., Ltd.20250—
+6K234067ImagingRing m (Version 2.0); Loop-X (Version 2.0); Loop-X Mobile Imaging Robot (Version…Medphoton GmbH20250—
+6K240099Ziehm Vision RFDZiehm Imaging GmbH202411
+6K231701Ziehm Vision RFD 3DZiehm Imaging GmbH202331
+6K211064nView s1 with nav optionNview Medical20211—
+6K211782ControlRad Select Model Z, ControlRad Trace Model 8, ControlRad Trace Model 9Controlrad, Inc.20210—
+6K200663ControlRad Trace Model 9Controlrad, Inc.20203—
+6K182626OEC OneGe Hualun Medical Systems Co., Ltd.20182—
+6K171565OEC EliteGe Oec Medical Systems, Inc.201764
+6K160984MultiScan G-Arm SystemBeijing East Whale Imaging Technology Co., Ltd.20161—
+7K243303Ziehm Vision RFD 3DZiehm Imaging GmbH20252—
+7K243328Ziehm Vision RFDZiehm Imaging GmbH20250—
+7K240828OEC One ASDGe Hualun Medical Systems Co., Ltd.20241—
+7K221344nView s1 with nav optionNview Medical20220—
+7K202431ControlRad Select Model ZControlrad, Inc.20202—
+7K172550OEC EliteGe Oec Medical Systems, Inc.201754
+7K163429B6Beijing East Whale Imaging Technology Co., Ltd.20170—
+8K252735C-beamPulmera, Inc.20260—
+8K253269OEC One CFDGe Hualun Medical Systems Co., Ltd.20250—
+8K213455ControlRad Select Model ZControlrad, Inc.20210—
+8K192819OEC EliteGe Oec Medical Systems, Inc.201924
+9K203346OEC 3DGe Oec Medical Systems, Inc.202113
+10K233669OEC 3DGe Oec Medical Systems, Inc.202402