510(k) K211951
K211951 is an FDA 510(k) premarket notification submitted by Cosmo Artificial Intelligence - Ai, Ltd. for the device "GI Genius". The FDA issued a decision of Substantially Equivalent on July 23, 2021. The device falls under product code QNP (Gastrointesinal Lesion Software Detection System), a Class II device regulated under 21 CFR 876.1520. Cosmo Artificial Intelligence - Ai, Ltd. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 23, 2021
- Date Received
- June 23, 2021
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Gastrointesinal Lesion Software Detection System
- Device Class
- Class II
- Regulation Number
- 876.1520
- Review Panel
- GU
- Submission Type
A gastrointestinal lesion software detection system is a computer-assisted detection device used in conjunction with endoscopy for the detection of abnormal lesions in the gastrointestinal tract. This device with advanced software algorithms brings attention to images to aid in the detection of lesions. The device may contain hardware to support interfacing with an endoscope.