510(k) Report

Devices descending from K091515

106 later devices reach Spy Scope Intra-Operative Operating System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K150956PINPOINT Endoscopic Fluorescence Imaging SystemNovadaq Technologies, Inc.2016701
+1K152204VS3-IR systemVisionsense, Ltd.201534—
+1K101077DA Vinci Fluorescence Imaging Vision System, Model FF 100Intuitive Surgical, Inc.20111042
+2K223020VS3-Iridium System (VS3-IR)Visionsense, Ltd.20220—
+2K202582Arthrex SynergyID Endoscopic Imaging SystemArthrex, Inc.20215—
+2K192292L10 LED Light Source with AIM, L11 LED Light Source with AIM, AIM SafeLight CableStryker20191—
+2K182606PINPOINT Endoscopic Fluorescence Imaging SystemNovadaq Technologies Ulc. (Now A Part of Stryker)201844—
+2K1821601688 Camera Control Unit ; 1688 AIM 4K Camera Head, C-Mount ; 1688 AIM 4K Camera Head…Stryker2018331
+2K170641da Vinci S/Si Endoscopes, da Vinci Xi EndoscopesIntuitive Surgical, Inc.20170—
+2K162882KARL STORZ ICG Imaging SystemKARL STORZ Endoscopy-America, Inc.201732—
+2K161792PINPOINT Endoscopic Fluorescence Imaging SystemNovadaq Technologies, Inc.201668—
+2K141077DA Vinci Firefly Imaging SystemIntuitive Surgical, Inc.2014872
+2K124031DA Vinci Fluorescence Imaging Vision SystemIntuitive Surgical, Inc.2013103—
+3K2603184K NIR/ICG Imaging SystemZhejiang Healnoc Technology Co., Ltd.20260—
+3K243591OPTOVISION Endoscopic Light Source UnitOptosurgical, LLC20250—
+3K233840Endoscopic Fluorescence Camera System (DPM-ENDOCAM-03PF)Zhuhai Dipu Medical Technology Co., Ltd.20240—
+3K232610da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke…Intuitive Surgical, Inc.2024116
+3K2318541788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIMStryker20235—
+3K223759Arthrex SynergyID Endoscopic Imaging SystemArthex, Inc.20234—
+3K221591Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope)…Schoelly Fiberoptic GmbH20231—
+3K221861FloNavi Endoscopic Fluorescence Imaging SystemGuangdong Optomedic Technologies, Inc.20232—
+3K221252Scivita 4KINSIGHT ICG Imaging SystemScivita Medical Technology Co., Ltd.20230—
+3K213943SmartSurgN Visualization SystemSmartsurgn Incorporated20221—
+3K212808Logic Hd camera head green, System greenRichard Wolf Medical Instruments Corporation20220—
+3K213710da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging SystemIntuitive Surgical, Inc.20222—
+3K210918da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging SystemIntuitive Surgical, Inc.20216—
+3K202925KARL STORZ ICG Imaging SystemKarl Storz Endoscopy_America, Inc.20207—
+3K202592Adavanced Imaging Modality System (1688 4K Camera System With Advanced Imaging Modality…Stryker202026—
+3K200737SPY Portable Handheld Imaging (SPY-PHI) SystemNovadaq Technologies Ulc. (Now A Part of Stryker)20208—
+3K2003101688 Pendulum 4K Camera Head with Integrated Coupler, 1688 4K Camera Control Unit with…Stryker20200—
+3K191851VS3-IRMedtronic20196—
+3K191046L10 LED Light Source with AIM, L11 LED Light Source with AIMStryker20192—
+3K180146KARL STORZ ICG Imaging SystemKarl Storz Endoscopy America, Inc.201830—
+3K171238KARL STORZ ICG Imaging SystemKARL STORZ Endoscopy-America, Inc.201731—
+3K152583KARL STORZ Endoscopic ICG Imaging SystemKARL STORZ Endoscopy-America, Inc.201636—
+3K142310Stryker Infrared Fluorescence (IRF) Imaging SystemStryker Endoscopy201476—
+4K261037780 nm SPY Portable Handheld Imaging (SPY-PHI) SystemStryker Endoscopy20260—
+4K260695da Vinci Firefly Imaging SystemIntuitive Surgical20260—
+4K242163SmartSurgN Visualization SystemSmartsurgN, Inc.20260—
+4K260108L12 LED Light Source with AIMStryker Endoscopy20260—
+4K251739da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20262—
+4K251336VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700); VISERA ELITE III Light…Olympus Medical Systems Corp.20250—
+4K251994Arthrex Synergy Vision Imaging SystemArthrex, Inc.20250—
+4K251227da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20250—
+4K250442da Vinci Surgical System, IS5000Intuitive Surgical, Inc.20250—
+4K251213Da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20250—
+4K251202da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20251—
+4K243641da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20241—
+4K233391cCeLL - In vivoVPIX Medical, Inc.20240—
+4K241530Stellar Imaging SystemGuangdong Optomedic Technologies, Inc.20241—
+4K241284da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20242—
+4K233225SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit, Camera Head…Schoelly Fiberoptic GmbH20240—
+4K2338923D Endoscopic Fluorescence Camera System (DPM-ENDOCAM-06PF)Zhuhai Dipu Medical Technology Co., Ltd.20240—
+4K233451Arthrex Synergy Vision Endoscopic Imaging SystemArthrex, Inc.20243—
+4K2333271788 4K Camera System with Advanced Imaging ModalityStryker Endoscopy20241—
+4K230407FloNavi Open Field Fluorescence Imaging SystemGuangdong Optomedic Technologies, Inc.20230—
+4K230727SPY Portable Handheld Imaging (SPY-PHI) SystemNovadaq Technologies Ulc (A Part of Stryker)20234—
+4K222827da Vinci Firefly Imaging SystemIntuitive Surgical, Inc.20220—
+4K212101da Vinci SP Firefly Imaging SystemIntuitive Surgical, Inc.20212—
+4K210265VS3 Iridium SytemVisionsense, Ltd.20215—
+4K212695KARL STORZ ICG Imaging SystemKarl Storz Endoscopy America20215—
+4K2112021688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, Precision S…Stryker202119—
+4K2100881688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, AIM…Stryker202125—
+4K203550ActivSight Intraoperative Imaging SystemActiv Surgical, Inc.20212—
+4K202244SPY-PHI System with SPY-PHI Fluorescence Assessment SoftwareNovadaq Technologies Ulc. (Now A Part of Stryker)20205—
+4K201399HOPKINS ICG/NIR 10mm Ridgid Endoscope (modified) 0°, 30°, 45°, HOPKIN ICG/NIR 5mm Ridgid…Karl Storz-Endoscopy-America, Inc.20208—
+4K200542Visera Elite II Xenon Light Source, Telescope IR/Telescope Ultra, Visera Elite II Video…Olympus Medical Systems Corp.20200—
+4K173866Stryker AIM Light Source and SafeLight cableStryker201834—
+4K151243STRYKER INFRARED ILLUMINATION SYSTEM (IRIS) [AIM Light Source and IRIS Ureteral Kit]Stryker Endoscopy201534—
+5K262547KARL STORZ TIPCAM1 RubinaKALR STORZ SE & Co. KG20260—
+5K261823da Vinci Surgical System, Model IS5000Intuitive Surgical, Inc.20260—
+5K261824da Vinci Surgical System, Model IS5000Intuitive Surgical, Inc.20260—
+5K254180PerfusiX-ImagingLIMIS Development B.V.20260—
+5K253602Precision S 4K SinuscopeStryker Endoscopy20260—
+5K253181SURGIMAGE SIM 1000H Fluorescence Imaging PlatformSurgimage Corporation20260—
+5K253986da Vinci Force Feedback InstrumentsIntuitive Surgical, Inc.20260—
+5K254242KARL STORZ ICG Imaging System with RUBINA® LensKarl Storz SE & CO. KG20260—
+5K2601851688 4K Camera System with Advanced Imaging Modality; 1788 4K Camera System with…Stryker Endoscopy20260—
+5K2526973D LaparoscopeGuangdong Optomedic Technologies, Inc.20250—
+5K243645IC-Flow™ Imaging System 2.0Diagnostic Green GmbH20250—
+5K250786SP Endoscope, 0° (430600)Intuitive Surgical, Inc.20251—
+5K243008Arthrex NanoScope SystemArthrex, Inc.20254—
+5K241361Arthrex Synergy Vision Endoscopic Imaging SystemArthrex, Inc.20242—
+5K233333KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control UnitKarl Storz SE & CO. KG20232—
+5K232857KARL STORZ ICG Imaging SystemKarl Storz SE & CO. KG20230—
+5K231344ActivSight Intraoperative Imaging SystemActiv Surgical, Inc.20230—
+5K222240Explorer Air® IISurgvision GmbH20231—
+5K2221301688 4K Camera System with Advanced Imaging ModalityStryker20220—
+5K221217SPY LaparoscopeStryker20221—
+5K214046780 nm 1688 4K Camera System, 780 nm L11 LED Light Source with AIM and Safelight CableStryker202214—
+5K2208951688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), 1688 4K…Stryker20220—
+5K220477Cellvizio 100 series system with confocal MiniprobesMauna Kea Technologies20221—
+5K2125111688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), AIM 4K…Stryker20210—
+6K251852cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200)VPIX Medical, Inc.20260—
+6K253972IMAGE1 (TC400US); X-to-4U Adapter (TC040)Karl Storz SE & CO. KG20260—
+6K252640VereSee Optical Veres Needle and Endoscopic CameraFreyja Healthcare, LLC20251—
+6K252350da Vinci SP Firefly Imaging SystemIntuitive Surgical, Inc.20250—
+6K252010SPY LaparoscopeStryker Endoscopy20250—
+6K250728Arthrex Synergy Vision Endoscopic Imaging SystemArthrex, Inc.20251—
+6K234090EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004)Surgvision GmbH20240—