GI Genius System 100 and GI Genius System 200 (K231143)
Description
GI Genius System 100 and GI Genius System 200 by Cosmo Artificial Intelligence - Ai, Ltd., an FDA 510(k) cleared gastroenterology, urology device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K231143
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. GI Genius System 100 and GI Genius System 200 (K231143) cites 1 predicate device and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K211951 | GI Genius | Cosmo Artificial Intelligence - Ai,... | 2021 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K233964 | GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (G... | Cosmo Artificial Intelligence - Ai,... | 2024 |
Trace the full predicate network for K231143
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.