Argus Cognitive ReVISION Software
510(k) K223322
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK223322 | Date24 Jul 2023 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- LLZ
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.2050
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Argus Cognitive ReVISION Software is a medical imaging analysis tool designed for the quantification and assessment of right ventricular (RV) structures and function. It leverages 3D echocardiographic data to provide detailed analysis of RV mechanics, including longitudinal shortening, radial shortening, and anteroposterior motion, contributing to the evaluation of right ventricle ejection fraction (RVEF). This software aids in the diagnostic process for adult patients with suspected cardiopulmonary conditions by offering objective measurements to support clinical decision-making.
This software is intended for use in clinical settings where cardiac imaging is performed, such as hospitals and specialized cardiology centers. It is supplied as a digital solution requiring compatible imaging systems for data input and analysis. The device is not described as single-use or reusable, nor is there mention of sterility or MRI safety considerations. Authorized for use in the United States under an FDA 510(k) clearance (K223322), the software falls under the product code LLZ and was reviewed by the Radiology Advisory Committee.
Other devices from Argus Cognitive, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Argus Cognitive ReVISION Software used for?
The Argus Cognitive ReVISION Software is designed to analyze and quantify right ventricular (RV) structures and function using 3D echocardiographic data. It provides detailed measurements of RV mechanics, including longitudinal shortening, radial shortening, and anteroposterior motion, which help clinicians evaluate right ventricle ejection fraction (RVEF). This aids in diagnosing and assessing adult patients with suspected cardiopulmonary conditions by offering objective, data-driven insights to support clinical decision-making.
How is the Argus Cognitive ReVISION Software supplied and used?
The software is supplied as a digital solution that requires compatible imaging systems to input and analyze 3D echocardiographic data. It is intended for use in clinical settings such as hospitals and specialized cardiology centers, where cardiac imaging is performed. The software does not require physical hardware beyond the necessary imaging infrastructure, making it a flexible tool for existing echocardiographic workflows.
Is the Argus Cognitive ReVISION Software single-use or reusable?
The Argus Cognitive ReVISION Software is not described as single-use or reusable. As a digital tool, it is designed for repeated use within compatible imaging systems, provided the software remains updated and the underlying hardware meets operational requirements. There are no sterility considerations or physical disposal requirements associated with its use.
What regulatory approval does the Argus Cognitive ReVISION Software hold?
The Argus Cognitive ReVISION Software holds FDA 510(k) clearance (K223322) in the United States, indicating it has been deemed substantially equivalent to a legally marketed predicate device. The software was reviewed by the Radiology Advisory Committee and falls under product code LLZ, ensuring it meets regulatory standards for medical imaging analysis tools.
Can the Argus Cognitive ReVISION Software be used with any echocardiographic imaging system?
The software is intended for use with compatible imaging systems capable of generating 3D echocardiographic data. While the exact compatibility requirements are not detailed in the specifications, the manufacturer specifies it as a digital solution designed to integrate with existing clinical imaging workflows. Clinicians should verify system compatibility with the manufacturer’s guidelines before implementation.