510(k) Report

Devices descending from K984545

266 later devices reach Release 2 of Philips Integris Series (V5000, BV5000, H5000, BH5000, HM2000)… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K232189OrionXRHoth Intelligence, Inc.20230—
+6K230407FloNavi Open Field Fluorescence Imaging SystemGuangdong Optomedic Technologies, Inc.20230—
+6K223759Arthrex SynergyID Endoscopic Imaging SystemArthex, Inc.20234—
+6K221591Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope)…Schoelly Fiberoptic GmbH20231—
+6K221861FloNavi Endoscopic Fluorescence Imaging SystemGuangdong Optomedic Technologies, Inc.20232—
+6K221252Scivita 4KINSIGHT ICG Imaging SystemScivita Medical Technology Co., Ltd.20230—
+6K213943SmartSurgN Visualization SystemSmartsurgn Incorporated20221—
+6K212808Logic Hd camera head green, System greenRichard Wolf Medical Instruments Corporation20220—
+6K213710da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging SystemIntuitive Surgical, Inc.20222—
+6K210918da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging SystemIntuitive Surgical, Inc.20216—
+6K202925KARL STORZ ICG Imaging SystemKarl Storz Endoscopy_America, Inc.20207—
+6K202592Adavanced Imaging Modality System (1688 4K Camera System With Advanced Imaging Modality…Stryker202026—
+6K200713EchoNavigatorPhilips Medical Systems Nederland B.V.20202—
+6K2003101688 Pendulum 4K Camera Head with Integrated Coupler, 1688 4K Camera Control Unit with…Stryker20200—
+6K191851VS3-IRMedtronic20196—
+6K191046L10 LED Light Source with AIM, L11 LED Light Source with AIMStryker20192—
+6K180146KARL STORZ ICG Imaging SystemKarl Storz Endoscopy America, Inc.201830—
+6K172607Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System…Philips Health Care20172831
+6K171238KARL STORZ ICG Imaging SystemKARL STORZ Endoscopy-America, Inc.201731—
+6K152583KARL STORZ Endoscopic ICG Imaging SystemKARL STORZ Endoscopy-America, Inc.201636—
+6K142310Stryker Infrared Fluorescence (IRF) Imaging SystemStryker Endoscopy201476—
+6K133292Allura Xper FD; or TablePhilips Medical Systems Nederland B.V.20141545
+6K1321472D PerfusionPhilips Medical Systems Nederland B.V.201321
+6K131263XperguidePhilips Medical Systems Nederland B.V.20131—
+6K100849Sync-RX System, Model AS00010Sync-Rx, Ltd.20104—
+6K083745The IC-Pro System, Model Version 3.2Paieon, Inc.200930—
+7K260695da Vinci Firefly Imaging SystemIntuitive Surgical20260—
+7K242163SmartSurgN Visualization SystemSmartsurgN, Inc.20260—
+7K260108L12 LED Light Source with AIMStryker Endoscopy20260—
+7K251739da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20262—
+7K251336VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700); VISERA ELITE III Light…Olympus Medical Systems Corp.20250—
+7K251227da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20250—
+7K250442da Vinci Surgical System, IS5000Intuitive Surgical, Inc.20250—
+7K251213Da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20250—
+7K251202da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20251—
+7K243641da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20241—
+7K233391cCeLL - In vivoVPIX Medical, Inc.20240—
+7K241530Stellar Imaging SystemGuangdong Optomedic Technologies, Inc.20241—
+7K241284da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20242—
+7K233225SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit, Camera Head…Schoelly Fiberoptic GmbH20240—
+7K2338923D Endoscopic Fluorescence Camera System (DPM-ENDOCAM-06PF)Zhuhai Dipu Medical Technology Co., Ltd.20240—
+7K233451Arthrex Synergy Vision Endoscopic Imaging SystemArthrex, Inc.20243—
+7K2333271788 4K Camera System with Advanced Imaging ModalityStryker Endoscopy20241—
+7K222827da Vinci Firefly Imaging SystemIntuitive Surgical, Inc.20220—
+7K221270EchoNavigator R4.0Philips Medical Systems Nederland B.V.20221—
+7K212101da Vinci SP Firefly Imaging SystemIntuitive Surgical, Inc.20212—
+7K210265VS3 Iridium SytemVisionsense, Ltd.20215—
+7K212695KARL STORZ ICG Imaging SystemKarl Storz Endoscopy America20215—
+7K2112021688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, Precision S…Stryker202119—
+7K2100881688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, AIM…Stryker202125—
+7K203550ActivSight Intraoperative Imaging SystemActiv Surgical, Inc.20212—
+7K201743ClarifEye R1.0, ClarifEye NeedlePhilips Medical Systems Nederlands B.V.20210—
+7K201399HOPKINS ICG/NIR 10mm Ridgid Endoscope (modified) 0°, 30°, 45°, HOPKIN ICG/NIR 5mm Ridgid…Karl Storz-Endoscopy-America, Inc.20208—
+7K200542Visera Elite II Xenon Light Source, Telescope IR/Telescope Ultra, Visera Elite II Video…Olympus Medical Systems Corp.20200—
+7K181966SmartPerfusionPhilips Medical Systems Nederlands B.V.201801
+7K181485EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound…Philips Ultrasound, Inc.20182724
+7K173866Stryker AIM Light Source and SafeLight cableStryker201834—
+7K160455AneurysmFlowPhilips Medical Systems Nederland B.V.201601
+7K151243STRYKER INFRARED ILLUMINATION SYSTEM (IRIS) [AIM Light Source and IRIS Ureteral Kit]Stryker Endoscopy201534—
+7K141979Allura Xper FD Series / Allura Xper or Table SeriesPhilips Medical Systems Netherland BV20141381
+7K132558Sync-RX SystemVolcano Corporation201331
+7K110256The IC-Pro SystemPaieon, Inc.201115—
+7K100292Caas Qva 3D, Caas Qca 3DPie Medical Imaging BV201013—
+7K091781Guided Medical Positioning System (GMPS)Mediguide, Ltd.200911—
+8K262547KARL STORZ TIPCAM1 RubinaKALR STORZ SE & Co. KG20260—
+8K261823da Vinci Surgical System, Model IS5000Intuitive Surgical, Inc.20260—
+8K261824da Vinci Surgical System, Model IS5000Intuitive Surgical, Inc.20260—
+8K254180PerfusiX-ImagingLIMIS Development B.V.20260—
+8K253602Precision S 4K SinuscopeStryker Endoscopy20260—
+8K253614EchoNavigator R5.0Philips Medical Systems Nederland B.V.20260—
+8K253986da Vinci Force Feedback InstrumentsIntuitive Surgical, Inc.20260—
+8K2601851688 4K Camera System with Advanced Imaging Modality; 1788 4K Camera System with…Stryker Endoscopy20260—
+8K2526973D LaparoscopeGuangdong Optomedic Technologies, Inc.20250—
+8K250786SP Endoscope, 0° (430600)Intuitive Surgical, Inc.20251—
+8K243008Arthrex NanoScope SystemArthrex, Inc.20254—
+8K241361Arthrex Synergy Vision Endoscopic Imaging SystemArthrex, Inc.20242—
+8K233333KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control UnitKarl Storz SE & CO. KG20232—
+8K232857KARL STORZ ICG Imaging SystemKarl Storz SE & CO. KG20230—
+8K231344ActivSight Intraoperative Imaging SystemActiv Surgical, Inc.20230—
+8K2221301688 4K Camera System with Advanced Imaging ModalityStryker20220—
+8K221217SPY LaparoscopeStryker20221—
+8K214046780 nm 1688 4K Camera System, 780 nm L11 LED Light Source with AIM and Safelight CableStryker202214—
+8K2208951688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), 1688 4K…Stryker20220—
+8K220477Cellvizio 100 series system with confocal MiniprobesMauna Kea Technologies20221—
+8K2125111688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), AIM 4K…Stryker20210—
+8K200304EPIQ Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.2020243
+8K182857EPIQ Diagnostic Ultrasound System, EPIQ 5 Diagnostic Ultrasound System, EPIQ 7…Philips Ultrasound, Inc.20181923
+8K162148Allura Xper R9Philips Medical Systems Nethrlands BV201683
+8K161563Allura Xper FD series and Allura Xper OR Table seriesPhilips Medical Systems Nederland B.V.2016245
+8K1618392D Quantitative AnalysisPhilips Medical Systems Nederland B.V.20160—
+8K151904SyncVision SystemVolcano Corporation201521
+8K133993Caas WorkstationPie Medical Imaging201410—
+8K120282CardnavPaieon, Inc.20120—
+8K120296CPS Direct Mediguide Enabled Outer CatheterSt. Jude Medical, Cardiac Rhythm Management Divisi20121—
+8K120298CPS Excel Mediguide Enabled GuidewireSt. Jude Medical, Cardiac Rhythm Management Divisi20128—
+8K113594C-THV SystemPaieon, Inc.20120—
+8K113076Caas a-ValvePie Medical Imaging BV20121—
+9K251852cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200)VPIX Medical, Inc.20260—
+9K253972IMAGE1 (TC400US); X-to-4U Adapter (TC040)Karl Storz SE & CO. KG20260—
+9K252640VereSee Optical Veres Needle and Endoscopic CameraFreyja Healthcare, LLC20251—