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510(k) DEN190040

Caption Guidance by Bay Labs, Inc. — Product Code QJU

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
February 7, 2020
Date Received
August 27, 2019
Clearance Type
Direct
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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