Caption Guidance
Caption HealthCaption Guidance is an AI-powered software accessory designed to assist medical professionals in acquiring high-quality cardiac ultrasound images. It provides real-time feedback and guidance to help users obtain standard echocardiographic views, improving image quality and diagnostic accuracy.
Intended Use
The Caption Guidance software is intended to assist medical professionals in the acquisition of cardiac ultrasound images. It is indicated for use in 2D transthoracic echocardiography for adult patients to acquire standard cardiac views including parasternal, apical, and subcostal echocardiographic views.
Technology
Caption Guidance is a software-only AI device that provides real-time user guidance during echocardiography image acquisition by emulating sonographer expertise with features like Quality Meter feedback, Prescriptive Guidance for transducer manipulation, Auto-Capture of diagnostic quality images, and Save Best Clip functionality.
Performance
The device has partially updated algorithm changes according to a predetermined change control plan (PCCP) with all modifications trained, tuned, and locked prior to release. The software's safety and effectiveness remain substantially equivalent to the predicate device.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
7/17/2020
2 months - 2
FDA Approval
9/18/2020
Other devices from Caption Health
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