Name: Predicase
Price: 199 USD

K-number	K241887
Device name	GI Genius Module 100 (GGM100.US); GI Genius Module 200 (GGM200.US); ColonPRO 4.0 (CPRO40.US); GI Genius Module 300 (GGM300-US); ColonPRO 4.0 (CPRO40S-US)
Applicant	Cosmo Artificial Intelligence - Ai, Ltd.
Product code	QNP
Device class	Class II
Decision date	Jul 25, 2024
Decision	Substantially Equivalent
Regulation	876.1520

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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GI Genius Module 100 (GGM100.US); GI Genius Module 200 (GGM200.US); ColonPRO 4.0 (CPRO40.US); GI Genius Module 300 (GGM300-US); ColonPRO 4.0 (CPRO40S-US)

Everything you need for a 510(k) submission. Nothing you don't.

GI Genius Module 100 (GGM100.US); GI Genius Module 200 (GGM200.US); ColonPRO 4.0 (CPRO40.US); GI Genius Module 300 (GGM300-US); ColonPRO 4.0 (CPRO40S-US)