FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040)
K Number: K253801
·
Decision Apr 7, 2026
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
6
Review Days
130
Basic Information
- Device Name
- ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040)
- K Number
- K253801
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2380
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Anumana, Inc.
- Date Received
- November 28, 2025
- Decision Date
- April 7, 2026
- Product Code
- SHP
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| SHP | Cardiac Amyloidosis Machine Learning-Based Notification Software | FDA class 2 | Cardiovascular |
Other Clearances by Anumana, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K260300 | WatchMate Software | Jun 15, 2026 | Substantially Equivalent |
| K252360 | ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020) | Mar 28, 2026 | Substantially Equivalent |
| K250652 | ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010) | Jul 28, 2025 | Substantially Equivalent |
| K233160 | NeuTrace EP Mapping System v.2.1 | Nov 25, 2023 | Substantially Equivalent |
| K232699 | Low Ejection Fraction AI-ECG Algorithm | Sep 28, 2023 | Substantially Equivalent |