510(k) Report

Devices descending from K060867

134 later devices reach Spy Intraoperative Imaging System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K100371Spy Intra-Operative Imaging SystemNovadaq Technologies, Inc.201116—
+1K100468Zeiss Infrared 800 with Flow 800 OptionCarl Zeiss Surgical GmbH20104—
+1K073130Spy Fluorescent Imaging SystemNovadaq Technologies, Inc.200820—
+1K073088Spy Fluorescent Imaging SystemNovadaq Technologies, Inc.2008119—
+1K071619Spy Fluorescent Imaging SystemNovadaq Technologies, Inc.2007263
+1K072222Spy Fluorescent Imaging SystemNovadaq Technologies, Inc.20071291
+1K071037Spy Intra-Operative Imaging System, Model SP2000Novadaq Technologies, Inc.20071311
+1K063345Spy Imaging SystemNovadaq Technologies, Inc.20071311
+2K231986Modus IRSynaptive Medical, Inc.20240—
+2K231075Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option)Carl Zeiss Meditec, Inc.20230—
+2K202391DIR 800Aesculap, Inc.20211—
+2K182907SPY Elite Intraoperative Perfusion Assessment SystemNovadaq Technologies Ulc. (Now A Part of Stryker)201914—
+2K162885SPY Phi Open Field Handheld Fluorescence Imaging SystemNovadaq Technologies, Inc.2017101
+2K150018VS3-IR-MMS SystemVisionsense, Ltd.2015353
+2K130003Xiralite Flourescence Imaging System X4Mivenion GmbH20140—
+2K110480Pde Photodynamic EyeHamamatsu Photonics K.K.201213—
+2K091515Spy Scope Intra-Operative Operating SystemNovadaq Technologies, Inc.20091061
+2K080612Leica FL800Leica Microsystems (Schweiz) AG20089—
+3K243077Affirm 800Digital Surgery Systems, Inc. (D.B.A True Digital Surgery)20250—
+3K223020VS3-Iridium System (VS3-IR)Visionsense, Ltd.20220—
+3K214097Explorer Air IISurgvision GmbH20222—
+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—
+3K170239Leica FL560Leica Microsystems (Schweiz) AG20170—
+3K150956PINPOINT Endoscopic Fluorescence Imaging SystemNovadaq Technologies, Inc.2016701
+3K152204VS3-IR systemVisionsense, Ltd.201534—
+3K143474Artemis Hand Held Imaging SystemQuest Medical Imaging201501
+3K141136Leica FL800Leica Biosystems Richmond20143—
+3K133719Pde-NeoHamamatsu Photonics K.K.201411—
+3K101077DA Vinci Fluorescence Imaging Vision System, Model FF 100Intuitive Surgical, Inc.20111042
+4K243645IC-Flow™ Imaging System 2.0Diagnostic Green GmbH20250—
+4K230727SPY Portable Handheld Imaging (SPY-PHI) SystemNovadaq Technologies Ulc (A Part of Stryker)20234—
+4K222240Explorer Air® IISurgvision GmbH20231—
+4K202582Arthrex SynergyID Endoscopic Imaging SystemArthrex, Inc.20215—
+4K200737SPY Portable Handheld Imaging (SPY-PHI) SystemNovadaq Technologies Ulc. (Now A Part of Stryker)20208—
+4K192292L10 LED Light Source with AIM, L11 LED Light Source with AIM, AIM SafeLight CableStryker20191—
+4K190772SURGICAL MICROSCOPE SYSTEM ORBEYE with IROlympus Medical Systems Corp.20190—
+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
+4K181537GLOW800Leica Microsystems (Schweiz) AG20180—
+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—
+5K261037780 nm SPY Portable Handheld Imaging (SPY-PHI) SystemStryker Endoscopy20260—
+5K2603184K NIR/ICG Imaging SystemZhejiang Healnoc Technology Co., Ltd.20260—
+5K253181SURGIMAGE SIM 1000H Fluorescence Imaging PlatformSurgimage Corporation20260—
+5K254242KARL STORZ ICG Imaging System with RUBINA® LensKarl Storz SE & CO. KG20260—
+5K251994Arthrex Synergy Vision Imaging SystemArthrex, Inc.20250—
+5K243591OPTOVISION Endoscopic Light Source UnitOptosurgical, LLC20250—
+5K233840Endoscopic Fluorescence Camera System (DPM-ENDOCAM-03PF)Zhuhai Dipu Medical Technology Co., Ltd.20240—
+5K234090EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004)Surgvision GmbH20240—
+5K232610da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke…Intuitive Surgical, Inc.2024116
+5K2318541788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIMStryker20235—
+5K230407FloNavi Open Field Fluorescence Imaging SystemGuangdong Optomedic Technologies, Inc.20230—
+5K223759Arthrex SynergyID Endoscopic Imaging SystemArthex, Inc.20234—
+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—
+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—
+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—
+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—
+6K243641da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20241—
+6K233391cCeLL - In vivoVPIX Medical, Inc.20240—
+6K241530Stellar Imaging SystemGuangdong Optomedic Technologies, Inc.20241—
+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—
+6K233451Arthrex Synergy Vision Endoscopic Imaging SystemArthrex, Inc.20243—
+6K2333271788 4K Camera System with Advanced Imaging ModalityStryker Endoscopy20241—
+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—
+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—
+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—