1 device · 1 company · 2023
Product code QVD: Radiological Machine Learning Based Quantitative Imaging Software With Change Control Plan
1 device under product code QVD, 2023, from 1 company. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (1 of 1 here), the regulation, and MAUDE report counts by product code.
Radiological Machine Learning Based Quantitative Imaging Software With Change Control Plan. 21 CFR 892.2055, Class II. 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. MAUDE held 0 adverse-event reports against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.
Retrieved from FDA public records.
Every device, newest decision first
| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| Caption Interpretation Automated Ejection FractiDEN220063 · De Novo | Caption Health, Inc | Radiology | database entry |
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