510(k) K253801
- Device
- ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040)
- Applicant
- Anumana, Inc.
- 510(k) number
- K253801
- Product code
- SHP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-04-07
- Date received
- 2025-11-28
- Regulation
- 870.2380
- Classification name
- Cardiac Amyloidosis Machine Learning-Based Notification Software
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Vyaas Shankar
- Address
- One Main St., Suite 400 East Arcade 4th Floor Cambridge MA US 02142 02142