QNP
22 FDA 510(k) clearances · Product code
32 daysmedian time to decision
263 days90th percentile
22clearances measured
FDA profile
- Official device name
- Gastrointesinal Lesion Software Detection System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1520
- Medical specialty
- Gastroenterology, Urology
- FDA definition
- 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.
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Every clearance here is in the API, with alerts when new ones post.