510(k) Report

Devices descending from K040675

49 later devices reach Axiom Artis U through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K100371Spy Intra-Operative Imaging SystemNovadaq Technologies, Inc.201116—
+1K070834CS-Series Fluoroscopy System, CS-10 Through CS-65 (11 Configurations)Omega Medical Imaging, Inc.20079—
+1K062647E-View Fluoroscopy System, Model CS-50Omega Medical Imaging, Inc.200610—
+1K051133Arcadis AvanticSiemens Medical Solutions USA, Inc.200520—
+2K182907SPY Elite Intraoperative Perfusion Assessment SystemNovadaq Technologies Ulc. (Now A Part of Stryker)201914—
+2K181550Cios SpinSiemens Medical Solutions USA, Inc.2018104
+2K181560Cios AlphaSiemens Medical Systems USA, Inc.2018107
+2K162885SPY Phi Open Field Handheld Fluorescence Imaging SystemNovadaq Technologies, Inc.2017101
+2K132094Cios AlphaSiemens Medi Cal Solutions, Inc.2014198
+2K100102CS-Series-FPOmega Medical Imaging, Inc.20108—
+3K251520Cios Alpha; Cios FlowSiemens Medical Solutions USA, Inc.20250—
+3K214097Explorer Air IISurgvision GmbH20222—
+3K210309Cios Select (VA21) Flat PanelSiemens Medical Solutions USA, Inc.202121
+3K210054Cios SpinSiemens Medical Systems USA, Inc.202131
+3K210055Cios AlphaSiemens Medical Solutions USA, Inc.202111
+3K203504Cios FlowSiemens Medical Solutions USA, Inc.202091
+3K202244SPY-PHI System with SPY-PHI Fluorescence Assessment SoftwareNovadaq Technologies Ulc. (Now A Part of Stryker)20205—
+3K192761Asimov-MKS Imaging SystemOnlume, Inc.20200—
+3K192174SPY Portable Handheld Imaging (SPY-PHI) SystemNovadaq Technologies Ulc. (Now A Part of Stryker)20199—
+3K153244Cios FusionSiemens Medical Solutions USA, Inc.2016151
+3K153147Cios ConnectSiemens Medical Solutions USA, Inc.20160—
+3K121293CS-Series-FP with 3030+OptionOmega Medical Imaging, LLC20127—
+4K253296Digital C-ARM with 3DAllengers Medical Systems Limited20260—
+4K251523Cios SpinSiemens Medical Solutions USA, Inc.20250—
+4K233748CIARTIC Move (VB10)Siemens Medical Solutions USA, Inc.20240—
+4K230727SPY Portable Handheld Imaging (SPY-PHI) SystemNovadaq Technologies Ulc (A Part of Stryker)20234—
+4K222240Explorer Air® IISurgvision GmbH20231—
+4K223410Cios Select (VA21) Flat PanelSiemens Medical Solutions USA, Inc.20221—
+4K200218Digiscan FDXAllengers Medical Systems Limited20201—
+4K200737SPY Portable Handheld Imaging (SPY-PHI) SystemNovadaq Technologies Ulc. (Now A Part of Stryker)20208—
+4K183144uMC 560iShanghai United Imaging Healthcare Co., Ltd.20190—
+4K182834CS-series-FP with Optional ROI Accessory CA-100SOmega Medical Imaging, LLC20194—
+4K181767Cios SelectSiemens Medical Solutions USA, Inc.20185—
+4K171755CS-series-FP with MX CFP 3131 or MX CFP 2222 Option Radiographic/Fluoroscopy SystemOmega Medical Imaging, LLC20181—
+5K261037780 nm SPY Portable Handheld Imaging (SPY-PHI) SystemStryker Endoscopy20260—
+5K253181SURGIMAGE SIM 1000H Fluorescence Imaging PlatformSurgimage Corporation20260—
+5K254242KARL STORZ ICG Imaging System with RUBINA® LensKarl Storz SE & CO. KG20260—
+5K250241Cios SelectSiemens Medical Solutions USA, Inc.20250—
+5K251994Arthrex Synergy Vision Imaging SystemArthrex, Inc.20250—
+5K243645IC-Flow™ Imaging System 2.0Diagnostic Green GmbH20250—
+5K234090EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004)Surgvision GmbH20240—
+5K230407FloNavi Open Field Fluorescence Imaging SystemGuangdong Optomedic Technologies, Inc.20230—
+5K212890Nyquist.IQOmega Medical Imaging, LLC20210—
+5K212336Soteria.AIOmega Medical Imaging, LLC20211—
+5K210307Cios Select (VA21) Image IntensifierSiemens Medical Solutions USA, Inc.20211—
+5K201172CFP-3131, CFP-2222Mx Imaging, Inc.20200—
+5K191713CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield™…Omega Medical Imaging, LLC20190—
+6K242488Soteria E-ViewOmega Medical Imaging, LLC20250—
+6K223409Cios Select (VA21) Image IntensifierSiemens Medical Solutions USA, Inc.20220—