Devices · Caption Health, Inc.

Cardiac Guidance

Caption Health, Inc. is listed for Cardiac Guidance (K243065). The FDA list gives January 15, 2025 as the date of the final decision. The lead panel is Radiology, and the database link on the FDA list is the 510(k) pathway. openFDA describes product code QJU as “Image Acquisition And/Or Optimization Guided By Artificial Intelligence”: 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. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K243065

Official FDA database record

Date of final decision

January 15, 2025

Company on the FDA list

Caption Health, Inc.

Lead panel

Radiology

Primary product code

QJU

openFDA device name for the code

Image Acquisition And/Or Optimization Guided By Artificial Intelligence

Device class

2

Regulation number

892.2100

openFDA decision description

Substantially Equivalent

openFDA decision code

SESE

Statement or summary label

Summary