Radiology

Quantitative Imaging AI With a Change Control Plan

Measures something on a scan, and comes with an agreed plan letting the maker update the model without starting over.

1 products cleared under FDA code QVD, from February 24, 2023 to February 24, 2023. Checked September 25, 2026.

This device type is short on products and long on significance, so it is worth the two minutes.

Every other clearance on this list is a snapshot. The FDA reviewed the model as it was that day. If the company wants to retrain it, that is a new conversation.

A change control plan flips that. The company agrees up front how the model may be updated, what it must prove each time, and what would stop it. The FDA clears the plan alongside the product.

That is the regulator admitting out loud that this software is not a scalpel. It changes. Expect more clearances to look like this, and treat the presence of such a plan as a maturity signal when you are comparing vendors.

Clearances per Year

What the FDA Actually Signed Off On

FDA product code
QVD
FDA name for it
Radiological Machine Learning Based Quantitative Imaging Software With Change Control Plan
Rule number
21 CFR 892.2055
Risk class
Class 2
Medical field
Radiology
The FDA's own wording: 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.

Before You Sign Anything

  • Ask to see the change control plan. It tells you what the vendor is allowed to change without telling you.
  • Ask how you will be notified of a model update, and whether you can stay on a previous version while you revalidate.
  • Ask what local monitoring they expect you to run. A model that may drift needs someone watching it on your side.

Every Cleared Product, Newest First

Each row links to the FDA's own record. The number in the last column is the clearance number, which is the single best thing to ask a vendor for.

ProductCompanyClearedFDA record
Caption Interpretation Automated Ejection Fraction Software Caption Health, Inc. February 24, 2023 DEN220063

Other Radiology Device Types

Clearance data comes from the FDA's public 510(k) and device classification records through openFDA. A clearance means the FDA agreed the product is close enough to something already on the market, not that the FDA tested it in your hospital. It says nothing about accuracy in your patient mix, your scanners, or your workflow. Confirm the current status and the exact cleared indication on the FDA record before you buy.