Radiology
Caption Interpretation Automated Ejection Fraction Software
Caption Health, Inc
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.
FDA Submission Metadata
- Submission number
- DEN220063
- Decision date
- February 2023
- FDA panel
- Radiology
- Product code
- QVD
- Clinical task (npj)
- quantification/feature localization
- Data modality (npj)
- Images
This entry is sourced from the FDA AI/ML-Enabled Medical Devices list. No editorial review yet — the catalogue may add a deeper review of this device in future.
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