De Novo · Radiology

Caption Guidance

by Bay Labs, Inc.

Caption Guidance is an AI-enabled medical device from Bay Labs, Inc. that the U.S. FDA granted through De Novo DEN190040 on February 7, 2020. Its lead review panel is Radiology and its primary product code is QJU (Image Acquisition And/Or Optimization Guided By Artificial Intelligence).

See also FDA-cleared AI radiology devices in 2020, all FDA AI clearances in 2020, top radiology AI devices.

Key facts

Submission numberDEN190040
PathwayDe Novo
Date of final decision
Company (FDA list)Bay Labs, Inc.
Lead review panelRadiology
Primary product codeQJU — Image Acquisition And/Or Optimization Guided By Artificial Intelligence
Applicant (openFDA)Bay Labs, Inc.
Applicant locationSan Francisco, CA, US
Device classClass 2
Regulation number21 CFR 892.2100
Decision codeDENG
Submission typeDirect

Source: FDA AI-Enabled Medical Devices list and openFDA.

What this means

De Novo is the pathway for novel low-to-moderate-risk devices with no predicate. A granted De Novo creates a new device classification that later devices can use as a predicate. Caption Guidance went through this pathway (DEN190040).

openFDA lists it as a Class 2 device under 21 CFR 892.2100. Class II devices are moderate risk and are subject to general and special controls.

Product code QJU covers 8 devices on the FDA AI list. By decision date, this device is #1 of 8 under that code. Bay Labs, Inc. has 2 AI-enabled devices on the list, and the Radiology panel accounts for 1,230 in total.

Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.

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