510(k) Report

Devices descending from K040347

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K081672C-InsightMazor Surgical Technologies, Ltd.200833—
+1K060226Oncor ExpressionSiemens Medical Solutions USA, Inc.20061372
+1K042793Arcadis Ordic (Available with Options 3D and 3D Navigation Interface)Siemens Medi Cal Solutions, Inc.2004212
+2K2538993D-AnywhereProvect.AI20260—
+2K202547Surgivisio systemSurgivisio20219—
+2K181550Cios SpinSiemens Medical Solutions USA, Inc.2018104
+2K123812Coherence RT Therapist Connect Workspace, V2.3, Aria Connectivity Option for Siemens…Siemens Medical Solutions USA, Inc.201339
+2K102671Syngo RT Therapist Connect Workspace, V4.2Siemens Medical Solutions USA, Inc.20105—
+2K102130Tenzing SystemMazor Surgical Technologies, Ltd.201031—
+2K092145160MLC OptionSiemens Medical Solutions USA, Inc.2009411
+2K090683Syngo RT Therapist ConnectSiemens Medical Solutions USA, Inc.200974
+2K083502Panther Realart, Model 4.7Prowess, Inc.20090—
+2K082775Prescision OptionSiemens Medical Solutions USA, Inc.20099—
+2K072485Artiste MV SASiemens Medical Solutions USA, Inc.20071124
+3K231886SURGIVISIO DeviceEcential Robotics20236—
+3K220946SURGIVISIO DeviceEcential Robotics20227—
+3K220627SURGIVISIO DeviceEcential Robotics20228—
+3K210309Cios Select (VA21) Flat PanelSiemens Medical Solutions USA, Inc.202121
+3K210054Cios SpinSiemens Medical Systems USA, Inc.202131
+3K203504Cios FlowSiemens Medical Solutions USA, Inc.202091
+3K132935Artiste Solution with Sys_VC10C and Syngo RT Therapist Workspace, V4.3.1 Upgrade Kit…Siemens Medical Solutions USA, Inc.20142—
+3K110911Renaissance SystemMazor Robotics, Ltd.201124—
+3K103606Artiste Solution with Sys_VB50 UpdateSiemens Medical Solutions USA, Inc.201147
+3K103400Fluoromap Software, 9 Fluorodisc (Belt), 12 Fluoro Disc (Belt), Close Tube ClipStryker Corporation20115—
+3K100096Linac Collimator Assembly Housing (Lcah) Model LcahartIntegra Radionics, Inc.20100—
+4K253296Digital C-ARM with 3DAllengers Medical Systems Limited20260—
+4K251523Cios SpinSiemens Medical Solutions USA, Inc.20250—
+4K251520Cios Alpha; Cios FlowSiemens Medical Solutions USA, Inc.20250—
+4K242890SPINEART Navigation Instrument SystemSpineart SA20253—
+4K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+4K233748CIARTIC Move (VB10)Siemens Medical Solutions USA, Inc.20240—
+4K223410Cios Select (VA21) Flat PanelSiemens Medical Solutions USA, Inc.20221—
+4K210055Cios AlphaSiemens Medical Solutions USA, Inc.202111
+4K182359HipCheckStryker Corp.20181—
+4K173946ADAPT for Gamma3Stryker GmbH20182—
+4K142434Artiste Solution, Sys_VC10C, Phase 2 Update with the Syngo RT Therapist & RT Oncologist…Siemens Medical Solutions USA, Inc.201415
+4K120812RenaissanceMazor Robotics, Ltd.2012211
+4K121295Artistetm Solution with Sys VcioSiemens Medical Solutions USA, Inc.201235
+4K113228Renaissance SystemMazor Robotics, Ltd.201123—
+5K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+5K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+5K250241Cios SelectSiemens Medical Solutions USA, Inc.20250—
+5K242933SPINEART Navigation Instrument SystemSpineart SA20252—
+5K230045HipCheckStryker Corp.20230—
+5K181848ADAPT for Gamma3, Gamma3Stryker GmbH20181—
+5K182050Linear Accelerator Control Console Software v13.1.010 Update, syngo Radiation Therapy…Siemens Medical Solutions USA, Inc.20180—
+5K152041Renaissance X SystemMazor Robotics, Ltd.201520—
+5K140167Renaissance X SystemMazor Robotics, Ltd.201421—
+6K254158SPINEART Navigation Instrument SystemSpineart SA20261—
+6K202749ADAPT for Gamma3Stryker GmbH20200—
+6K163221Mazor XMazor Robotics, Ltd.201719—
+7K180307Mazor XMazor Robotics, Ltd.201817—
+7K172522Mazor XMazor Robotics, Ltd.20170—
+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—