510(k) Report

Devices descending from K211951

11 later devices reach GI Genius through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K230751EW10-EC02 Endoscopy Support ProgramFujifilm Corporation20231—
+1K223473ME-Apds™; Magentiq-Colo™Magentiq Eye, Ltd.20233—
+1K231143GI Genius System 100 and GI Genius System 200Cosmo Artificial Intelligence - Ai, Ltd.20234—
+2K260567EW10-EC02 Endoscopy Support ProgramFujifilm Corporation20260—
+2K244023Magentiq-Colo (ME-Apds)Magentiq Eye, Ltd.20252—
+2K233964GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US); ColonPRO™ 4.0…Cosmo Artificial Intelligence - Ai, Ltd.20243—
+3K252853CAD - Lower GI (EC07-01)Xiamen Inno Medical Technology Co., Ltd.20260—
+3K252178Magentiq-Colo (ME-Apds)Magentiq Eye, Ltd.20251—
+3K241887GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US); ColonPRO™ 4.0…Cosmo Artificial Intelligence - Ai, Ltd.20241—
+4K261369GI Genius™ Module 300 (GGM300-US);ColonPRO™ US (CPRO403S-US)Cosmo Artificial Intelligence - Ai, Ltd.20260—
+4K260724Magentiq-Colo (ME-Apds)Magentiq Eye, Ltd.20260—