510(k) K252853
K252853 is an FDA 510(k) premarket notification submitted by Xiamen Inno Medical Technology Co., Ltd. for the device "CAD - Lower GI (EC07-01)". The FDA issued a decision of Substantially Equivalent on August 5, 2026. The device falls under product code QNP (Gastrointesinal Lesion Software Detection System), a Class II device regulated under 21 CFR 876.1520.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 5, 2026
- Date Received
- September 8, 2025
- Clearance Type
- Traditional
- 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.