510(k) · Radiology

Cardiac Guidance

by Caption Health, Inc.

Cardiac Guidance is an AI-enabled medical device from Caption Health, Inc. that the U.S. FDA cleared through 510(k) K243065 on January 15, 2025. 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 2025, all FDA AI clearances in 2025, top radiology AI devices.

Key facts

Submission numberK243065
Pathway510(k)
Date of final decision
Company (FDA list)Caption Health, Inc.
Lead review panelRadiology
Primary product codeQJU — Image Acquisition And/Or Optimization Guided By Artificial Intelligence
Applicant (openFDA)Caption Health, Inc.
Applicant locationSan Mateo, 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. Cardiac Guidance went through this pathway (K243065).

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 #5 of 8 under that code. Caption Health, 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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