510(k) Report

Devices descending from K032280

83 later devices reach Siremobil Iso-C 3D through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K081672C-InsightMazor Surgical Technologies, Ltd.200833—
+1K061310Ziehm Vario 3D Digital Mobile Imaging SystemZiehm Imaging, Inc.200629—
+1K050996O-Arm Imaging SystemBreakaway Imaging, LLC2005524
+2K2538993D-AnywhereProvect.AI20260—
+2K102130Tenzing SystemMazor Surgical Technologies, Ltd.201031—
+2K092564O-Arm Imaging SystemMedtronic Navigation, Inc. (Littleton)20101618
+2K073346Ziehm Vision 2Ziehm Imaging, Inc.2008285
+2K060344O-Arm Imaging SystemBreakaway Imaging, LLC2006511
+3K210912Excelsius3DGlobus Medical, Inc.202110—
+3K161976Ziehm Solo FDZiehm Imaging GmbH201681
+3K151000O-Arm O2 Imaging SystemMedtronic, Inc.2015157
+3K142740Ziehm Vision RFD 3DZiehm Imaging GmbH2015101
+3K110911Renaissance SystemMazor Robotics, Ltd.201124—
+3K103400Fluoromap Software, 9 Fluorodisc (Belt), 12 Fluoro Disc (Belt), Close Tube ClipStryker Corporation20115—
+3K092438Ziehm SoloZiehm Imaging, Inc.200994
+3K083545Ziehm Vision RFDZiehm Imaging, Inc.2009173
+4K231669Ziehm Solo FDZiehm Imaging GmbH20232—
+4K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+4K203281Mobile ImagingRing System, IRm, Loop-X Mobile Imaging Robot, Loop-XMedphoton GmbH20201—
+4K202360Ziehm Vision RFD 3DZiehm Imaging GmbH20204—
+4K190064nView system 1Nview Medical, Inc.20192—
+4K183220OrthoScan TAU Mini C-ArmOrthoscan, Inc.20194—
+4K182359HipCheckStryker Corp.20181—
+4K173946ADAPT for Gamma3Stryker GmbH20182—
+4K173664Medtronic O-arm O2 Imaging SystemMedtronic, Inc.2017142
+4K132904Ziehm Vision RFDZiehm Imaging GmbH2013161
+4K120812RenaissanceMazor Robotics, Ltd.2012211
+4K113228Renaissance SystemMazor Robotics, Ltd.201123—
+5K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+5K241525ExcelsiusXR™Globus Medical, Inc.20250—
+5K234067ImagingRing m (Version 2.0); Loop-X (Version 2.0); Loop-X Mobile Imaging Robot (Version…Medphoton GmbH20250—
+5K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+5K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+5K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+5K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+5K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+5K234109Ziehm Solo FDZiehm Imaging GmbH202411
+5K230045HipCheckStryker Corp.20230—
+5K231701Ziehm Vision RFD 3DZiehm Imaging GmbH202331
+5K211064nView s1 with nav optionNview Medical20211—
+5K213113Orthoscan Tau Mini C-ArmOrthoscan, Inc.20213—
+5K203428Ziehm Vision RFDZiehm Imaging GmbH20213—
+5K200218Digiscan FDXAllengers Medical Systems Limited20201—
+5K200074O-arm O2 Imaging SystemMedtronic, Inc.202013—
+5K181848ADAPT for Gamma3, Gamma3Stryker GmbH20181—
+5K152041Renaissance X SystemMazor Robotics, Ltd.201520—
+5K140167Renaissance X SystemMazor Robotics, Ltd.201421—
+6K253296Digital C-ARM with 3DAllengers Medical Systems Limited20260—
+6K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+6K250587Orthoscan TAU Mini C-ArmZiehm-Orthoscan, Inc.20251—
+6K243646Ziehm Solo FDZiehm Imaging GmbH20250—
+6K243303Ziehm Vision RFD 3DZiehm Imaging GmbH20252—
+6K243452Orthoscan VERSA Mini C-ArmZiehm-Orthoscan, Inc.202521
+6K240465O-arm O2 Imaging SystemMedtronic Navigation, Inc.202402
+6K231692Ziehm Vision RFDZiehm Imaging GmbH20232—
+6K221344nView s1 with nav optionNview Medical20220—
+6K221230TRONXoran Technologies, LLC20220—
+6K202749ADAPT for Gamma3Stryker GmbH20200—
+6K163221Mazor XMazor Robotics, Ltd.201719—
+7K252735C-beamPulmera, Inc.20260—
+7K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+7K252579Orthoscan TAU MVP Mini C-Arm SystemZiehm-Orthoscan, Inc.20260—
+7K240099Ziehm Vision RFDZiehm Imaging GmbH202411
+7K180307Mazor XMazor Robotics, Ltd.201817—
+7K172522Mazor XMazor Robotics, Ltd.20170—
+8K243328Ziehm Vision RFDZiehm Imaging GmbH20250—
+8K182077Mazor X System (Mazor X Stealth Edition)Mazor Robotics, Ltd.2018162
+9K200935Mazor XMazor Robotics, Ltd.202015—
+10K203005Mazor XMazor Robotics, Ltd.2020141
+11K230064Mazor X System (Mazor X Stealth Edition)Mazor Robotics, Ltd.202332
+11K211441Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.20219—
+12K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+12K251316Mazor X System / Mazor X Stealth EditionMazor Robotics, Ltd.20251—
+12K240625CORUS Navigation Access SystemProvidence Medical Technology, Inc.20244—
+12K232345ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc.20232—
+12K230716Robotic Graft Delivery InstrumentsMedtronic Sofamor Danek, Inc.20230—
+13K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+13K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+13K253381Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical applicationMedtronic Navigation, Inc.20260—
+13K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+13K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—
+14K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+14K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—