510(k) Report

Devices descending from K160044

6 later devices reach Image1 SPIES System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250204Endoscopic Camera SystemShenzhen Sophway Technology Co., Ltd.20250—
+1K201135Image1 S CCU, Image1 S 4U Camera HeadKARL STORZ Endoscopy-America, Inc.20204—
+2K250462UL UHD-Clear View 4K Camera System (UL-3Chip 4K)Univlabs Technologies Private Limited20250—
+2K233333KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control UnitKarl Storz SE & CO. KG20232—
+3K254242KARL STORZ ICG Imaging System with RUBINA® LensKarl Storz SE & CO. KG20260—
+3K253972IMAGE1 (TC400US); X-to-4U Adapter (TC040)Karl Storz SE & CO. KG20260—