510(k) Report

Devices descending from K233964

3 later devices reach GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US)… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252853CAD - Lower GI (EC07-01)Xiamen Inno Medical Technology Co., Ltd.20260—
+1K241887GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US); ColonPRO™ 4.0…Cosmo Artificial Intelligence - Ai, Ltd.20241—
+2K261369GI Genius™ Module 300 (GGM300-US);ColonPRO™ US (CPRO403S-US)Cosmo Artificial Intelligence - Ai, Ltd.20260—