Company ยท US
Anumana, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2023 to 2026. Name variants (Inc, Corp, punctuation) are merged.
6510(k) clearances (3 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| QYE | Reduced Ejection Fraction Machine Learning-Based Notification Software | 2 |
| DQK | Computer, Diagnostic, Programmable | 1 |
| QIH | Automated Radiological Image Processing Software | 1 |
| SAT | Pulmonary Hypertension Machine Learning-Based Notification Software | 1 |
| SHP | Cardiac Amyloidosis Machine Learning-Based Notification Software | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 15, 2026 | K260300 | WatchMate Software Anumana, Inc. | QIH |
| Apr 7, 2026 | K253801 | ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040) Anumana, Inc. | SHP |
| Mar 28, 2026 | K252360 | ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020) Anumana, Inc. | SAT |
| Jul 28, 2025 | K250652 | ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010) Anumana, Inc. | QYE |
| Nov 25, 2023 | K233160 | NeuTrace EP Mapping System v.2.1 Anumana, Inc. | DQK |
| Sep 28, 2023 | K232699 | Low Ejection Fraction AI-ECG Algorithm Anumana, Inc. | QYE |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||