510(k) DEN220063
DEN220063 is an FDA 510(k) premarket notification submitted by Caption Health, Inc. for the device "Caption Interpretation Automated Ejection Fraction Software". The FDA issued a decision of De Novo granted on Feb 24, 2023. The device falls under product code QVD (Radiological Machine Learning Based Quantitative Imaging Software With Change Control Plan), a Class II device regulated under 21 CFR 892.2055. Caption Health, Inc. has 5 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo granted)
- Decision Date
- Feb 24, 2023
- Date Received
- Sep 28, 2022
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Radiological Machine Learning Based Quantitative Imaging Software With Change Control Plan
- Device Class
- Class II
- Regulation Number
- 892.2055
- Review Panel
- RA
- Submission Type
- 510(k)
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.