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510(k) K200755

Caption Guidance by Caption Health — Product Code QJU

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 16, 2020
Date Received
March 23, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Image Acquisition And/Or Optimization Guided By Artificial Intelligence
Device Class
Class II
Regulation Number
892.2100
Review Panel
RA
Submission Type

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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