Medical Device Manufacturer · US , Cambridge , MA

Anumana, Inc. - FDA 510(k) Cleared Devices

6 submissions · 6 cleared · Since 2023

Recent clearances: ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040), ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020), ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010)

6
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6
Cleared
0
Denied

Anumana, Inc. has 6 FDA 510(k) cleared medical devices. Based in Cambridge, US.

Latest FDA clearance: Jun 2026. Active since 2023. Primary specialty: Cardiovascular.

Browse the FDA 510(k) cleared devices submitted by Anumana, Inc. Filter by specialty or product code using the sidebar.

2 submissions have an FDA-authorized Predetermined Change Control Plan (PCCP), indicating AI or software-based device development.

FDA 510(k) Regulatory Record - Anumana, Inc.

6 devices
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