510(k) Report

Devices descending from DEN200055

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252853CAD - Lower GI (EC07-01)Xiamen Inno Medical Technology Co., Ltd.20260—
+1K240044CaddieOdin Medical Limited20242—
+1K213686SKOUT SoftwareIterative Scopes, Inc.20225—
+1K211326EndoScreenerChengdu Wision Medical Device Co., Ltd.20210—
+1K211951GI GeniusCosmo Artificial Intelligence - Ai, Ltd.202111—
+2K252586CaddieOdin Medical Limited20251—
+2K230751EW10-EC02 Endoscopy Support ProgramFujifilm Corporation20231—
+2K223473ME-Apds™; Magentiq-Colo™Magentiq Eye, Ltd.20233—
+2K231143GI Genius System 100 and GI Genius System 200Cosmo Artificial Intelligence - Ai, Ltd.20234—
+2K230658SKOUT® systemIterative Scopes, Inc.20234—
+3K260133CaddieOdin Medical Limited20260—
+3K260567EW10-EC02 Endoscopy Support ProgramFujifilm Corporation20260—
+3K244023Magentiq-Colo (ME-Apds)Magentiq Eye, Ltd.20252—
+3K240781SKOUT® systemIterative Scopes, Inc.20243—
+3K233964GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US); ColonPRO™ 4.0…Cosmo Artificial Intelligence - Ai, Ltd.20243—
+4K252178Magentiq-Colo (ME-Apds)Magentiq Eye, Ltd.20251—
+4K251126SKOUT systemIterative Health20251—
+4K241887GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US); ColonPRO™ 4.0…Cosmo Artificial Intelligence - Ai, Ltd.20241—
+4K241508SKOUT® systemIterative Scopes, Inc.20242—
+5K261369GI Genius™ Module 300 (GGM300-US);ColonPRO™ US (CPRO403S-US)Cosmo Artificial Intelligence - Ai, Ltd.20260—
+5K260724Magentiq-Colo (ME-Apds)Magentiq Eye, Ltd.20260—
+5K253664SKOUT systemIterative Health20250—