510(k) K253801
K253801 is an FDA 510(k) premarket notification submitted by Anumana, Inc. for the device "ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040)". The FDA issued a decision of Substantially Equivalent on April 7, 2026. The device falls under product code SHP (Cardiac Amyloidosis Machine Learning-Based Notification Software), a Class II device regulated under 21 CFR 870.2380. Anumana, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 7, 2026
- Date Received
- November 28, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cardiac Amyloidosis Machine Learning-Based Notification Software
- Device Class
- Class II
- Regulation Number
- 870.2380
- Review Panel
- CV
- Submission Type
Cardiac Amyloidosis machine learning-based notification software employs machine learning techniques to suggest the likelihood of cardiac amyloidosis for further referral or diagnostic follow-up.