Caption AI (Caption Guidance + Caption Interpretation)

Basic Information

• Brand Name: Caption AI (Caption Guidance + Caption Interpretation)
• Primary DI: 00860003586303
• Version / Model: 0.10, 0.11, 1.1, 1.2, 1.3, 1.4
• Catalog Number: 511-00003
• Company Name: CAPTION HEALTH, INC.
• Labeler DUNS: 079192179
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-06-05
• Public Version: 2
• Public Version Date: 2022-01-25
• Public Version Status: Update
• Public Device Record Key: 21d60619-0779-4423-b0f4-1cfdc2206f14
• Distribution End Date: 2021-09-30

Device Description

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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QJU	Image Acquisition And/Or Optimization Guided By Artificial Intelligence	Radiology	892.2100	2
QIH	Automated Radiological Image Processing Software	Radiology	892.2050	2

GMDN Terms

Code	Name	Definition	Implantable	Status
40873	Ultrasound imaging system application software	An individual software program or group of programs, routines or algorithms that add specific image processing and/or analysis capabilities to a diagnostic ultrasound system configuration. A basic set of applications programs and routines are included with such computer-controlled imaging systems and they can be upgraded to correct programming errors or to add new system capabilities. Some applications software programs or program packages must be combined with specific hardware or firmware configurations in order to function as intended. Applications program packages are typically identified by a proprietary name and "version" or "upgrade" number.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860003586303	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]