FDA product code QJU

Image Acquisition And/Or Optimization Guided By Artificial Intelligence

Radiology·Class 2·21 CFR 892.2100
US regulatory classifications
US Product Code (FDA)
QJU
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 892.2100
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Medical specialty
Radiology
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
Definition

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.

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About this record

Image Acquisition And/Or Optimization Guided By Artificial Intelligence is a medical device type in the Radiology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.