Caption AI (Caption Guidance + Caption Interpretation) 511-00003

GUDID 00860003586303

The Caption Guidance software is indicated for use in two-dimensional transthoracic echocardiography (2DTTE) for adult patients, specifically in the acquisition of the following standard views: Parasternal Long-Axis (PLAX), Parasternal Short-Axis at the Aortic Valve (PSAX-AV), Parasternal Short-Axis at the Mitral Valve (PSAX-MV), Parasternal Short-Axis at the Papillary Muscle (PSAX-PM), Apical 4-Chamber (AP4), Apical 5- Chamber (AP5), Apical 2-Chamber (AP2), Apical 3-Chamber (AP3), Subcostal 4-Chamber (SubC4), and Subcostal Inferior Vena Cava (SC-IVC). The Caption Interpretation Automated Ejection Fraction software is used to process previously acquired transthoracic cardiac ultrasound images, to store images, and to manipulate and make measurements on images using an ultrasound device, personal computer, or a compatible DICOM-compliant PACS system in order to provide automated estimation of left ventricular ejection fraction. This measurement can be used to assist the clinician in a cardiac evaluation. The Caption Interpretation Automated Ejection Fraction Software is indicated for use in adult patients.

CAPTION HEALTH, INC.

Ultrasound imaging system application software

• Primary Device ID: 00860003586303
• NIH Device Record Key: 21d60619-0779-4423-b0f4-1cfdc2206f14
• Commercial Distribution Discontinuation: 2021-09-30
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Caption AI (Caption Guidance + Caption Interpretation)
• Version Model Number: 0.10, 0.11, 1.1, 1.2, 1.3, 1.4
• Catalog Number: 511-00003
• Company DUNS: 079192179
• Company Name: CAPTION HEALTH, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (855) 506-4357
• Email: support@captionhealth.com
• Phone: (855) 506-4357
• Email: support@captionhealth.com
• Phone: (855) 506-4357
• Email: support@captionhealth.com
• Phone: (855) 506-4357
• Email: support@captionhealth.com
• Phone: (855) 506-4357
• Email: support@captionhealth.com
• Phone: (855) 506-4357
• Email: support@captionhealth.com
• Phone: (855) 506-4357
• Email: support@captionhealth.com
• Phone: (855) 506-4357
• Email: support@captionhealth.com
• Phone: (855) 506-4357
• Email: support@captionhealth.com
• Phone: (855) 506-4357
• Email: support@captionhealth.com
• Phone: (855) 506-4357
• Email: support@captionhealth.com
• Phone: (855) 506-4357
• Email: support@captionhealth.com
• Phone: (855) 506-4357
• Email: support@captionhealth.com
• Phone: (855) 506-4357
• Email: support@captionhealth.com
• Phone: (855) 506-4357
• Email: support@captionhealth.com
• Phone: (855) 506-4357
• Email: support@captionhealth.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860003586303 [Primary]

FDA Product Code

• QJU: Image Acquisition And/Or Optimization Guided By Artificial Intelligence

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2022-01-25
• Device Publish Date: 2020-06-05

On-Brand Devices [Caption AI (Caption Guidance + Caption Interpretation)]

• 00860003586303: The Caption Guidance software is indicated for use in two-dimensional transthoracic echocardiogr
• 00860003586310: Caption AI (Caption Guidance + Caption Interpretation) on portable handheld ultrasound. The Capt
• 00860003586341: Alastor