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.
Image Acquisition And/Or Optimization Guided By Artificial Intelligence
Radiology
The Image Acquisition And/Or Optimization Guided By Artificial Intelligence is a Class 2 radiology device intended to aid in the acquisition and/or optimization of radiological images and diagnostic signals by analyzing system output and providing guidance or feedback to the operator for improving image quality. It requires 510(k) clearance and is regulated under 21 CFR 892.2100 within the Radiology medical specialty. The product code is QJU. The device is not an implant and is not flagged as life-sustaining.
510(k) Clearances
6 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.