510(k) Report

Devices descending from K151011

3 later devices reach Visera 4K Uhd System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K2505514K Endoscopic Camera System (SV-800, SV-800I, SV-800R, SV-800N)Shenzhen Sophway Technology Co., Ltd.20250—
+1K2002164K UHD Camera SystemScivita Medical Technology Co., Ltd.20200—
+1K1728174K Camera Head Olympus CH-S400-XZ-EB, 4K Autoclavable Camera Head Olympus CH-S400-XZ-EAOlympus Medical Systems Corp.20170—