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.
Colon Computed Tomography System, Computer Aided Detection
Radiology
The Computer-Aided Detection Colon CT System is a radiology software device designed to assist radiologists in the review of multi-slice computed tomography (MSCT) examinations of the colon by highlighting potential polyps that the radiologist should review, serving as a second reader in virtual colonoscopy interpretation. It is an FDA Class 2 device regulated under 21 CFR 892.2050 in the Radiology specialty, with product code NWE, requiring 510(k) clearance. It is not an implant and does not carry life-sustaining support designation.
510(k) Clearances
4 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.