510(k) Report

Devices descending from K152583

36 later devices reach KARL STORZ Endoscopic ICG Imaging System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K213943SmartSurgN Visualization SystemSmartsurgn Incorporated20221—
+1K200542Visera Elite II Xenon Light Source, Telescope IR/Telescope Ultra, Visera Elite II Video…Olympus Medical Systems Corp.20200—
+1K162882KARL STORZ ICG Imaging SystemKARL STORZ Endoscopy-America, Inc.201732—
+2K242163SmartSurgN Visualization SystemSmartsurgN, Inc.20260—
+2K180146KARL STORZ ICG Imaging SystemKarl Storz Endoscopy America, Inc.201830—
+2K171238KARL STORZ ICG Imaging SystemKARL STORZ Endoscopy-America, Inc.201731—
+3K233391cCeLL - In vivoVPIX Medical, Inc.20240—
+3K212695KARL STORZ ICG Imaging SystemKarl Storz Endoscopy America20215—
+3K2112021688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, Precision S…Stryker202119—
+3K201399HOPKINS ICG/NIR 10mm Ridgid Endoscope (modified) 0°, 30°, 45°, HOPKIN ICG/NIR 5mm Ridgid…Karl Storz-Endoscopy-America, Inc.20208—
+4K262547KARL STORZ TIPCAM1 RubinaKALR STORZ SE & Co. KG20260—
+4K253602Precision S 4K SinuscopeStryker Endoscopy20260—
+4K233333KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control UnitKarl Storz SE & CO. KG20232—
+4K232857KARL STORZ ICG Imaging SystemKarl Storz SE & CO. KG20230—
+4K2221301688 4K Camera System with Advanced Imaging ModalityStryker20220—
+4K214046780 nm 1688 4K Camera System, 780 nm L11 LED Light Source with AIM and Safelight CableStryker202214—
+4K2208951688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), 1688 4K…Stryker20220—
+4K2125111688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), AIM 4K…Stryker20210—
+4K202925KARL STORZ ICG Imaging SystemKarl Storz Endoscopy_America, Inc.20207—
+5K254242KARL STORZ ICG Imaging System with RUBINA® LensKarl Storz SE & CO. KG20260—
+5K253972IMAGE1 (TC400US); X-to-4U Adapter (TC040)Karl Storz SE & CO. KG20260—
+5K251336VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700); VISERA ELITE III Light…Olympus Medical Systems Corp.20250—
+5K230754L12 LED Light Source with AIMStryker20236—
+5K2306051788 4K Camera System with Advanced Imaging ModalityStryker20236—
+5K2302161688 4K Camera Control Unit with Advanced Imaging Modality (1688010000)Stryker20238—
+5K221611780 nm L11 LED Light Source with AIMStryker202210—
+6K241361Arthrex Synergy Vision Endoscopic Imaging SystemArthrex, Inc.20242—
+6K2401741688 4K Camera System with Advanced Imaging ModalityStryker Endoscopy20241—
+6K2318541788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIMStryker20235—
+7K261037780 nm SPY Portable Handheld Imaging (SPY-PHI) SystemStryker Endoscopy20260—
+7K260695da Vinci Firefly Imaging SystemIntuitive Surgical20260—
+7K2601851688 4K Camera System with Advanced Imaging Modality; 1788 4K Camera System with…Stryker Endoscopy20260—
+7K260108L12 LED Light Source with AIMStryker Endoscopy20260—
+7K250728Arthrex Synergy Vision Endoscopic Imaging SystemArthrex, Inc.20251—
+7K2333271788 4K Camera System with Advanced Imaging ModalityStryker Endoscopy20241—
+8K251994Arthrex Synergy Vision Imaging SystemArthrex, Inc.20250—