510(k) Report

Devices descending from K131953

10 later devices reach IMAGE1 Spies through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K221781Image Processing Unit, Model: OPTO-CAM104K, Camera Head, Model: OPTO-CHD104KHGuangdong Optomedic Technologies, Inc.20230—
+1K190648Pusen Eview Medical Video Endoscope Image ProcessorZhuhai Pusen Medical Technology Co., Ltd.20191—
+1K160044Image1 SPIES SystemKarl Storz Endoscopy America, Inc.20166—
+2K251734ProVee Video Processing Unit (PV-003)Proverum Limited20250—
+2K250204Endoscopic Camera SystemShenzhen Sophway Technology Co., Ltd.20250—
+2K201135Image1 S CCU, Image1 S 4U Camera HeadKARL STORZ Endoscopy-America, Inc.20204—
+3K250462UL UHD-Clear View 4K Camera System (UL-3Chip 4K)Univlabs Technologies Private Limited20250—
+3K233333KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control UnitKarl Storz SE & CO. KG20232—
+4K254242KARL STORZ ICG Imaging System with RUBINA® LensKarl Storz SE & CO. KG20260—
+4K253972IMAGE1 (TC400US); X-to-4U Adapter (TC040)Karl Storz SE & CO. KG20260—