Product code QVD— Radiology
Caption Interpretation Automated Ejection Fraction Software
- Classification name
- Radiological Machine Learning Based Quantitative Imaging Software With Change Control Plan
- Device class
- Class 2
- Regulation
- 21 CFR 892.2055
- Advisory panel
- Radiology
- Total cleared
- 1
- First cleared
- Most recent
FDA classification 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.”
Market context for product code QVD
FDA has cleared device under product code QVD, all in 2023, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Top applicants under product code QVD
Recent clearances under product code QVD
Data sourced from openFDA. This site is unofficial and independent of the FDA.