510(k) Report

Devices descending from K031098

124 later devices reach 3-CCD Digital Camera System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K071756Endohub- 1.0 Endoscopic Video Camera System with Video CapturePointe Conception Medical, Inc.200715—
+1K063457Truehd (1080P) Digital Camera SystemConmed Linvatec2006116—
+2K161017True HD 3MOS Camera SystemConmed Corporation20161—
+2K153218Arthrex Synergy UHD4 SystemArthrex, Inc.201614—
+2K091515Spy Scope Intra-Operative Operating SystemNovadaq Technologies, Inc.20091061
+2K0809773 CCD Endocam 5550Richard Wolf Medical Instruments Corp.20087—
+3K202582Arthrex SynergyID Endoscopic Imaging SystemArthrex, Inc.20215—
+3K201593Looking Glass 4K Integrated Visualization SystemConmed Corporation20200—
+3K190645Arthrex NanoScope SystemArthrex, Inc.201912—
+3K161204ENDOCAM Flex HD Camera System 5521Richard Wolf Medical Instruments Corporation20170—
+3K150956PINPOINT Endoscopic Fluorescence Imaging SystemNovadaq Technologies, Inc.2016701
+3K152204VS3-IR systemVisionsense, Ltd.201534—
+3K130423The Richard Wolf Endocam Logic HD Camera System 5525Richard Wolf Medical Instruments Corp.20136—
+3K101077DA Vinci Fluorescence Imaging Vision System, Model FF 100Intuitive Surgical, Inc.20111042
+4K223759Arthrex SynergyID Endoscopic Imaging SystemArthex, Inc.20234—
+4K223020VS3-Iridium System (VS3-IR)Visionsense, Ltd.20220—
+4K201134Arthrex NanoScope SystemArthrex, Inc.202011—
+4K192292L10 LED Light Source with AIM, L11 LED Light Source with AIM, AIM SafeLight CableStryker20191—
+4K182606PINPOINT Endoscopic Fluorescence Imaging SystemNovadaq Technologies Ulc. (Now A Part of Stryker)201844—
+4K1821601688 Camera Control Unit ; 1688 AIM 4K Camera Head, C-Mount ; 1688 AIM 4K Camera Head…Stryker2018331
+4K180583Logic 4K Camera Controller, Logic 4K Camera HeadRichard Wolf Medical Instruments Corporation20184—
+4K170641da Vinci S/Si Endoscopes, da Vinci Xi EndoscopesIntuitive Surgical, Inc.20170—
+4K162882KARL STORZ ICG Imaging SystemKARL STORZ Endoscopy-America, Inc.201732—
+4K161792PINPOINT Endoscopic Fluorescence Imaging SystemNovadaq Technologies, Inc.201668—
+4K141077DA Vinci Firefly Imaging SystemIntuitive Surgical, Inc.2014872
+4K124031DA Vinci Fluorescence Imaging Vision SystemIntuitive Surgical, Inc.2013103—
+5K260414“Tech-Image” Video Endoscope SystemTech-Image CO., LTD.20260—
+5K2603184K NIR/ICG Imaging SystemZhejiang Healnoc Technology Co., Ltd.20260—
+5K2528584K UHD Endoscopy Camera System (KMS-4K-2088, KMS-4K-2188, KMS-4K-2288)Kms Medical Technology Co., Ltd.20260—
+5K253217MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500)…Medimaging Integrated Solution, Inc (Miis)20250—
+5K241990SpineSite Endoscope SystemHydrocision, Inc.20250—
+5K243591OPTOVISION Endoscopic Light Source UnitOptosurgical, LLC20250—
+5K243008Arthrex NanoScope SystemArthrex, Inc.20254—
+5K233840Endoscopic Fluorescence Camera System (DPM-ENDOCAM-03PF)Zhuhai Dipu Medical Technology Co., Ltd.20240—
+5K232610da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke…Intuitive Surgical, Inc.2024116
+5K233451Arthrex Synergy Vision Endoscopic Imaging SystemArthrex, Inc.20243—
+5K2318541788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIMStryker20235—
+5K221591Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope)…Schoelly Fiberoptic GmbH20231—
+5K221861FloNavi Endoscopic Fluorescence Imaging SystemGuangdong Optomedic Technologies, Inc.20232—
+5K221252Scivita 4KINSIGHT ICG Imaging SystemScivita Medical Technology Co., Ltd.20230—
+5K213943SmartSurgN Visualization SystemSmartsurgn Incorporated20221—
+5K212808Logic Hd camera head green, System greenRichard Wolf Medical Instruments Corporation20220—
+5K213710da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging SystemIntuitive Surgical, Inc.20222—
+5K210918da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging SystemIntuitive Surgical, Inc.20216—
+5K202925KARL STORZ ICG Imaging SystemKarl Storz Endoscopy_America, Inc.20207—
+5K202592Adavanced Imaging Modality System (1688 4K Camera System With Advanced Imaging Modality…Stryker202026—
+5K200617Logic HD Camera Controller, Logic HD Lite Camera Controller, Logic 4K Camera Contoller…Richard Wolf Medical Instruments Corporation20202—
+5K200737SPY Portable Handheld Imaging (SPY-PHI) SystemNovadaq Technologies Ulc. (Now A Part of Stryker)20208—
+5K2003101688 Pendulum 4K Camera Head with Integrated Coupler, 1688 4K Camera Control Unit with…Stryker20200—
+5K191851VS3-IRMedtronic20196—
+5K191046L10 LED Light Source with AIM, L11 LED Light Source with AIMStryker20192—
+5K180146KARL STORZ ICG Imaging SystemKarl Storz Endoscopy America, Inc.201830—
+5K171238KARL STORZ ICG Imaging SystemKARL STORZ Endoscopy-America, Inc.201731—
+5K152583KARL STORZ Endoscopic ICG Imaging SystemKARL STORZ Endoscopy-America, Inc.201636—
+5K142310Stryker Infrared Fluorescence (IRF) Imaging SystemStryker Endoscopy201476—
+6K261037780 nm SPY Portable Handheld Imaging (SPY-PHI) SystemStryker Endoscopy20260—
+6K260695da Vinci Firefly Imaging SystemIntuitive Surgical20260—
+6K242163SmartSurgN Visualization SystemSmartsurgN, Inc.20260—
+6K260108L12 LED Light Source with AIMStryker Endoscopy20260—
+6K251739da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20262—
+6K251336VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700); VISERA ELITE III Light…Olympus Medical Systems Corp.20250—
+6K252640VereSee Optical Veres Needle and Endoscopic CameraFreyja Healthcare, LLC20251—
+6K251994Arthrex Synergy Vision Imaging SystemArthrex, Inc.20250—
+6K251227da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20250—
+6K250442da Vinci Surgical System, IS5000Intuitive Surgical, Inc.20250—
+6K251213Da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20250—
+6K251202da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20251—
+6K250728Arthrex Synergy Vision Endoscopic Imaging SystemArthrex, Inc.20251—
+6K243641da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20241—
+6K233391cCeLL - In vivoVPIX Medical, Inc.20240—
+6K241530Stellar Imaging SystemGuangdong Optomedic Technologies, Inc.20241—
+6K241361Arthrex Synergy Vision Endoscopic Imaging SystemArthrex, Inc.20242—
+6K241284da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20242—
+6K233225SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit, Camera Head…Schoelly Fiberoptic GmbH20240—
+6K2338923D Endoscopic Fluorescence Camera System (DPM-ENDOCAM-06PF)Zhuhai Dipu Medical Technology Co., Ltd.20240—
+6K2333271788 4K Camera System with Advanced Imaging ModalityStryker Endoscopy20241—
+6K230407FloNavi Open Field Fluorescence Imaging SystemGuangdong Optomedic Technologies, Inc.20230—
+6K230727SPY Portable Handheld Imaging (SPY-PHI) SystemNovadaq Technologies Ulc (A Part of Stryker)20234—
+6K222827da Vinci Firefly Imaging SystemIntuitive Surgical, Inc.20220—
+6K212101da Vinci SP Firefly Imaging SystemIntuitive Surgical, Inc.20212—
+6K210265VS3 Iridium SytemVisionsense, Ltd.20215—
+6K212695KARL STORZ ICG Imaging SystemKarl Storz Endoscopy America20215—
+6K211332D Camera ControllerRichard Wolf Medical Instruments Corporation20210—
+6K2112021688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, Precision S…Stryker202119—
+6K2100881688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, AIM…Stryker202125—
+6K203550ActivSight Intraoperative Imaging SystemActiv Surgical, Inc.20212—
+6K202244SPY-PHI System with SPY-PHI Fluorescence Assessment SoftwareNovadaq Technologies Ulc. (Now A Part of Stryker)20205—
+6K201399HOPKINS ICG/NIR 10mm Ridgid Endoscope (modified) 0°, 30°, 45°, HOPKIN ICG/NIR 5mm Ridgid…Karl Storz-Endoscopy-America, Inc.20208—
+6K200542Visera Elite II Xenon Light Source, Telescope IR/Telescope Ultra, Visera Elite II Video…Olympus Medical Systems Corp.20200—
+6K173866Stryker AIM Light Source and SafeLight cableStryker201834—
+6K151243STRYKER INFRARED ILLUMINATION SYSTEM (IRIS) [AIM Light Source and IRIS Ureteral Kit]Stryker Endoscopy201534—
+7K262547KARL STORZ TIPCAM1 RubinaKALR STORZ SE & Co. KG20260—
+7K261823da Vinci Surgical System, Model IS5000Intuitive Surgical, Inc.20260—
+7K261139VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)Freyja Healthcare, LLC20260—
+7K261824da Vinci Surgical System, Model IS5000Intuitive Surgical, Inc.20260—
+7K254180PerfusiX-ImagingLIMIS Development B.V.20260—
+7K253602Precision S 4K SinuscopeStryker Endoscopy20260—
+7K253181SURGIMAGE SIM 1000H Fluorescence Imaging PlatformSurgimage Corporation20260—
+7K253986da Vinci Force Feedback InstrumentsIntuitive Surgical, Inc.20260—
+7K254242KARL STORZ ICG Imaging System with RUBINA® LensKarl Storz SE & CO. KG20260—