510(k) Report

Devices descending from K961182

44 later devices reach 3D Scope through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K9702143 Dimensional Video EndoscopeOktas199742—
+1K970369Vista Mini Camera SystemOktas19970—
+2K990635Vista Stereoscope SystemVista Medical Technologies, Inc.199941—
+3K082355Visionsense Stereoscopic Vision SystemVisionsense, Ltd.200837—
+3K020301Modification to Vista Stereoscope SystemVista Medical Technologies, Inc.20022—
+4K141002VS3 Stereoscopic High Definition Vision SystemVisionsense, Ltd.201436—
+4K021290Vista Visualization System, Model 9000, Vista Visualization System with Voice Activation…Vista Medical Technologies, Inc.20021—
+5K153548VS3 Stereoscopic High Definition Vision SystemVisionsense, Ltd.20160—
+5K152204VS3-IR systemVisionsense, Ltd.201534—
+5K1018103DHJD Camera System ModelVision Systems Group, A Division of Viking Systems20100—
+6K223020VS3-Iridium System (VS3-IR)Visionsense, Ltd.20220—
+6K162882KARL STORZ ICG Imaging SystemKARL STORZ Endoscopy-America, Inc.201732—
+7K180146KARL STORZ ICG Imaging SystemKarl Storz Endoscopy America, Inc.201830—
+7K171238KARL STORZ ICG Imaging SystemKARL STORZ Endoscopy-America, Inc.201731—
+8K233391cCeLL - In vivoVPIX Medical, Inc.20240—
+8K212695KARL STORZ ICG Imaging SystemKarl Storz Endoscopy America20215—
+8K2112021688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, Precision S…Stryker202119—
+8K201399HOPKINS ICG/NIR 10mm Ridgid Endoscope (modified) 0°, 30°, 45°, HOPKIN ICG/NIR 5mm Ridgid…Karl Storz-Endoscopy-America, Inc.20208—
+9K262547KARL STORZ TIPCAM1 RubinaKALR STORZ SE & Co. KG20260—
+9K253602Precision S 4K SinuscopeStryker Endoscopy20260—
+9K233333KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control UnitKarl Storz SE & CO. KG20232—
+9K232857KARL STORZ ICG Imaging SystemKarl Storz SE & CO. KG20230—
+9K2221301688 4K Camera System with Advanced Imaging ModalityStryker20220—
+9K214046780 nm 1688 4K Camera System, 780 nm L11 LED Light Source with AIM and Safelight CableStryker202214—
+9K2208951688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), 1688 4K…Stryker20220—
+9K2125111688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), AIM 4K…Stryker20210—
+9K202925KARL STORZ ICG Imaging SystemKarl Storz Endoscopy_America, Inc.20207—
+10K254242KARL STORZ ICG Imaging System with RUBINA® LensKarl Storz SE & CO. KG20260—
+10K253972IMAGE1 (TC400US); X-to-4U Adapter (TC040)Karl Storz SE & CO. KG20260—
+10K251336VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700); VISERA ELITE III Light…Olympus Medical Systems Corp.20250—
+10K230754L12 LED Light Source with AIMStryker20236—
+10K2306051788 4K Camera System with Advanced Imaging ModalityStryker20236—
+10K2302161688 4K Camera Control Unit with Advanced Imaging Modality (1688010000)Stryker20238—
+10K221611780 nm L11 LED Light Source with AIMStryker202210—
+11K241361Arthrex Synergy Vision Endoscopic Imaging SystemArthrex, Inc.20242—
+11K2401741688 4K Camera System with Advanced Imaging ModalityStryker Endoscopy20241—
+11K2318541788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIMStryker20235—
+12K261037780 nm SPY Portable Handheld Imaging (SPY-PHI) SystemStryker Endoscopy20260—
+12K260695da Vinci Firefly Imaging SystemIntuitive Surgical20260—
+12K2601851688 4K Camera System with Advanced Imaging Modality; 1788 4K Camera System with…Stryker Endoscopy20260—
+12K260108L12 LED Light Source with AIMStryker Endoscopy20260—
+12K250728Arthrex Synergy Vision Endoscopic Imaging SystemArthrex, Inc.20251—
+12K2333271788 4K Camera System with Advanced Imaging ModalityStryker Endoscopy20241—
+13K251994Arthrex Synergy Vision Imaging SystemArthrex, Inc.20250—