Caption Interpretation Automated Ejection Fraction Software is an AI-enabled medical device from Caption Health, Inc that the U.S. FDA granted through De Novo DEN220063 on February 24, 2023. Its lead review panel is Radiology and its primary product code is QVD (Radiological Machine Learning Based Quantitative Imaging Software With Change Control Plan).
See also FDA-cleared AI radiology devices in 2023, all FDA AI clearances in 2023, top radiology AI devices.
Key facts
| Submission number | DEN220063 |
|---|---|
| Pathway | De Novo |
| Date of final decision | |
| Company (FDA list) | Caption Health, Inc |
| Lead review panel | Radiology |
| Primary product code | QVD — Radiological Machine Learning Based Quantitative Imaging Software With Change Control Plan |
| Applicant (openFDA) | Caption Health, Inc. |
| Applicant location | Brisbane, CA, US |
| Device class | Class 2 |
| Regulation number | 21 CFR 892.2055 |
| Decision code | DENG |
| Submission type | Direct |
Source: FDA AI-Enabled Medical Devices list and openFDA.
What this means
De Novo is the pathway for novel low-to-moderate-risk devices with no predicate. A granted De Novo creates a new device classification that later devices can use as a predicate. Caption Interpretation Automated Ejection Fraction Software went through this pathway (DEN220063).
openFDA lists it as a Class 2 device under 21 CFR 892.2055. Class II devices are moderate risk and are subject to general and special controls.
Product code QVD covers 1 device on the FDA AI list. By decision date, this device is #1 of 1 under that code. Caption Health, Inc has 2 AI-enabled devices on the list, and the Radiology panel accounts for 1,230 in total.
Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.