Devices · Caption Health, Inc

Caption Interpretation Automated Ejection Fraction Software

Caption Health, Inc is listed for Caption Interpretation Automated Ejection Fraction Software (DEN220063). The FDA list gives February 24, 2023 as the date of the final decision. The lead panel is Radiology, and the database link on the FDA list is the De Novo pathway. openFDA describes product code QVD as “Radiological Machine Learning Based Quantitative Imaging Software With Change Control Plan”: A radiological machine learning quantitative imaging software with predetermined change control plan is a software-only device which employs machine learning algorithms on radiological images to provide quantitative imaging outputs. The device includes functions to support outputs such as view selection, segmentation and landmarking. The design specifications include planned modifications that may be made to the device consistent with an established predetermined change control plan. openFDA records this submission’s decision description as “Unknown.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN220063

Official FDA database record

Date of final decision

February 24, 2023

Company on the FDA list

Caption Health, Inc

Lead panel

Radiology

Primary product code

QVD

openFDA device name for the code

Radiological Machine Learning Based Quantitative Imaging Software With Change Control Plan

Device class

2

Regulation number

892.2055

openFDA decision description

Unknown

openFDA decision code

DENG

Statement or summary label

Not returned