QVD — Radiological Machine Learning Based Quantitative Imaging Software With Change Control Plan Class II
FDA product code QVD covers "Radiological Machine Learning Based Quantitative Imaging Software With Change Control Plan", a Class II medical device regulated under 21 CFR 892.2055. Submissions are reviewed by the Radiology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- QVD
- Device Class
- Class II
- Regulation Number
- 892.2055
- Submission Type
- Review Panel
- RA
- Medical Specialty
- Radiology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN220063 | caption health | Caption Interpretation Automated Ejection Fraction Software | February 24, 2023 |