Cardiology
Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000)
Abbott
FDA-cleared AI medical device
FDA Submission Metadata
- Submission number
- K251221
- Decision date
- September 2025
- FDA panel
- Cardiovascular
- Product code
- MXD
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.
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.