Image Acquisition And/Or Optimization Guided By Artificial Intelligence

QJU · Class II — Moderate Risk (510(k) clearance required) · Radiology · 21 CFR 892.2100

Classification

FDA Product Code: QJU
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 892.2100
Review panel: RA
Medical specialty: Radiology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 7
Registered establishments: 3

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown