FDA product code QVD: Radiological Machine Learning Based Quantitative Imaging Software With Change Control Plan

QVD is the FDA product code for radiological machine learning based quantitative imaging software with change control plan. It is a Class II device, regulated under 21 CFR 892.2055 and reviewed by the Radiology panel. Devices under QVD reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.

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.

Classification

Recalls for QVD devices

openFDA lists no recalls for product code QVD.

Frequently asked questions

What is FDA product code QVD?

QVD is the FDA product code for radiological machine learning based quantitative imaging software with change control plan. It is a Class II device, regulated under 21 CFR 892.2055 and reviewed by the Radiology panel.

What device class is QVD?

Class II, regulation 21 CFR 892.2055. Typical premarket route: 510(k).

Next steps

• Run an FDA pathway report with predicate devices for product code QVD
• Run a recall and safety report across every QVD manufacturer
• Watch product code QVD for new clearances and recalls

Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.

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