510(k) Report

Devices descending from K063345

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K210265VS3 Iridium SytemVisionsense, Ltd.20215—
+6K2125111688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), AIM 4K…Stryker20210—
+6K2100881688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, AIM…Stryker202125—
+6K203550ActivSight Intraoperative Imaging SystemActiv Surgical, Inc.20212—
+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—
+7K261823da Vinci Surgical System, Model IS5000Intuitive Surgical, Inc.20260—
+7K261824da Vinci Surgical System, Model IS5000Intuitive Surgical, Inc.20260—
+7K254180PerfusiX-ImagingLIMIS Development B.V.20260—
+7K253986da Vinci Force Feedback InstrumentsIntuitive Surgical, Inc.20260—
+7K2601851688 4K Camera System with Advanced Imaging Modality; 1788 4K Camera System with…Stryker Endoscopy20260—
+7K253972IMAGE1 (TC400US); X-to-4U Adapter (TC040)Karl Storz SE & CO. KG20260—
+7K2526973D LaparoscopeGuangdong Optomedic Technologies, Inc.20250—
+7K250786SP Endoscope, 0° (430600)Intuitive Surgical, Inc.20251—
+7K243008Arthrex NanoScope SystemArthrex, Inc.20254—
+7K241361Arthrex Synergy Vision Endoscopic Imaging SystemArthrex, Inc.20242—
+7K231344ActivSight Intraoperative Imaging SystemActiv Surgical, Inc.20230—
+7K230754L12 LED Light Source with AIMStryker20236—
+7K2306051788 4K Camera System with Advanced Imaging ModalityStryker20236—
+7K2302161688 4K Camera Control Unit with Advanced Imaging Modality (1688010000)Stryker20238—
+7K221611780 nm L11 LED Light Source with AIMStryker202210—
+7K221217SPY LaparoscopeStryker20221—
+7K220477Cellvizio 100 series system with confocal MiniprobesMauna Kea Technologies20221—
+8K251852cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200)VPIX Medical, Inc.20260—
+8K252640VereSee Optical Veres Needle and Endoscopic CameraFreyja Healthcare, LLC20251—
+8K252350da Vinci SP Firefly Imaging SystemIntuitive Surgical, Inc.20250—
+8K252010SPY LaparoscopeStryker Endoscopy20250—
+8K250728Arthrex Synergy Vision Endoscopic Imaging SystemArthrex, Inc.20251—
+8K2401741688 4K Camera System with Advanced Imaging ModalityStryker Endoscopy20241—
+9K261139VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)Freyja Healthcare, LLC20260—