Product code QVD

Device name

Radiological Machine Learning Based Quantitative Imaging Software With Change Control Plan

Medical specialty

Radiology

Device class

2

Regulation number

892.2055

Review panel

RA

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

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.

Source

FDA openFDA device classification dataset