510(k) Predicate Finder
Find potential predicate devices for your 510(k) submission. Enter a K-number to find all clearances with the same product code, a three-letter product code to browse clearances directly, or search by device name.
Gastrointesinal Lesion Software Detection System
Gastroenterology, Urology
The Gastrointestinal Lesion Software Detection System is a computer-assisted detection device used in conjunction with endoscopy to detect abnormal lesions in the gastrointestinal tract, using advanced software algorithms to bring attention to endoscopic images to aid in lesion detection. The device may include hardware to support interfacing with an endoscope. This device is classified as FDA Class 2, requiring 510(k) clearance, under regulation 876.1520 in the Gastroenterology and Urology specialty. It carries product code QNP and is not an implant and not life-sustaining.
510(k) Clearances
15 matchesWhat is a Predicate Device?
A predicate device is a legally marketed device that a new 510(k) applicant uses to demonstrate substantial equivalence. The FDA's 510(k) pathway requires manufacturers to show that their device has the same intended use and similar technological characteristics as one or more predicate devices already cleared for commercial distribution.
Finding the right predicate is a critical step in 510(k) strategy. Manufacturers typically search for cleared devices with the same FDA product code, which groups devices by their intended use and regulatory classification. This tool helps you identify potential predicates by browsing all clearances within a product code.
Note that predicate devices must be legally marketed — they cannot be devices that were cleared but never commercialized, or devices subject to a mandatory recall. The determination of substantial equivalence considers intended use, technological characteristics, and performance data.