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510(k) DEN220063

Caption Interpretation Automated Ejection Fraction Software by Caption Health, Inc. — Product Code QVD

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
February 24, 2023
Date Received
September 28, 2022
Clearance Type
Direct
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radiological Machine Learning Based Quantitative Imaging Software With Change Control Plan
Device Class
Class II
Regulation Number
892.2055
Review Panel
RA
Submission Type

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.

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