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Parker Quality & Compliance

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Device type

Image Acquisition And/Or Optimization Guided By Artificial Intelligence

Product code QJU · Class II · 21 CFR 892.2100 · Radiology

A radiological acquisition and/or optimization guidance system is a device that is intended to aid in the acquisition and/or optimization of images and/or diagnostic signals. The device interfaces with the acquisition system, analyzes its output, and provides guidance and/or feedback to the operator for improving image and/or signal quality.

FDA classification database

Recent 510(k)s

Oct 2, 2026

K261042

Lung Guidance

GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC

Recent recalls

No recalls in the archive for QJU.