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Image Acquisition And/Or Optimization Guided By Artificial Intelligence

FDA product code QJU · 8 cleared devices

Class 2 Radiology
Regulation
21 CFR 892.2100
Review panel
RA
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2020-04-16 – 2026-07-15

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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