QVD

1 FDA 510(k) clearances · Product code

FDA profile

Official device name

Radiological Machine Learning Based Quantitative Imaging Software With Change Control Plan

Device class

Class II (moderate risk)

Regulation

21 CFR 892.2055

Medical specialty

Radiology

FDA definition

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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