510(k) · Radiology

Caption Guidance

by Caption Health

Caption Guidance is an AI-enabled medical device from Caption Health that the U.S. FDA cleared through 510(k) K200755 on April 16, 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 numberK200755
Pathway510(k)
Date of final decision
Company (FDA list)Caption Health
Lead review panelRadiology
Primary product codeQJU — Image Acquisition And/Or Optimization Guided By Artificial Intelligence
Applicant (openFDA)Caption Health
Applicant locationBrisbane, CA, US
Device classClass 2
Regulation number21 CFR 892.2100
Decision codeSESE
Submission typeTraditional

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

What this means

A 510(k) is a premarket submission showing the device is substantially equivalent to a legally marketed predicate device. A cleared 510(k) means FDA agreed with that equivalence. Caption Guidance went through this pathway (K200755).

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 #2 of 8 under that code. Caption Health has 4 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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