Radiology
Fetal EchoScan
BrightHeart
FDA
FDA-cleared AI medical device
Assist users in characterizing lesions identified on acquired medical images
FDA Submission Metadata
- Submission number
- K242342
- Decision date
- November 2024
- FDA panel
- Radiology
- Product code
- POK
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.
Regulatory Approvals
FDA
US FDA 510k
K242342
This entry is on our editorial review queue. Full evaluation — performance metrics, clinical evidence, safety record — lands as our review pipeline graduates each device. The information above is what's been verified to date.