- All Devices
- Cardiology
- Reveal LINQ Insertable Cardiac Monitor, LINQ II Insertable Cardiac Monitor, AccuRhythm AI ECG Classification System
Cardiology
Reveal LINQ Insertable Cardiac Monitor, LINQ II Insertable Cardiac Monitor, AccuRhythm AI ECG Classification System
Medtronic, Inc.
FDA-cleared AI medical device
FDA Submission Metadata
- Submission number
- K223630
- Decision date
- April 2023
- FDA panel
- Cardiovascular
- Product code
- MXD
- Clinical task (npj)
- detection
- Data modality (npj)
- Signals
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.