ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040)
FDA 510(k) clearance K253801 · decided 2026-04-07
Clearance details
- K-number
- K253801
- Device name
- ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040)
- Applicant
- Anumana, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-11-28
- Decision date
- 2026-04-07
- Days to decision
- 130 days
- Clearance type
- Traditional
- Product code
- SHP
- Device class
- 2
- Regulation number
- 870.2380
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Cambridge, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.