# Anumana, Inc.

- Location (FDA's records): Cambridge, MA
- FDA decisions: 6 (2023–2026): 6 510(k) clearances
- Product codes: QYE (2), SHP (1), DQK (1), SAT (1), QIH (1)
- 510(k) review time since 2016: median 136 days, against 133 for FDA's reviews in the same codes and years (2 of 3 faster)
- Predicates its devices cite: 6 (3 its own); citations of its devices by later devices: 8 (3 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Viz. Ai, Inc.: 1 (https://510kreport.com/company/viz-ai)
- Biosense Webster, Inc.: 1 (https://510kreport.com/company/biosense-webster)
- Circle Cardiovascular Imaging, Inc.: 1 (https://510kreport.com/company/circle-cardiovascular-imaging)

## Firms that cite its devices most
- Tempus AI, Inc.: 2 (https://510kreport.com/company/tempus-ai)
- Eko Health, Inc.: 1 (https://510kreport.com/company/eko-health)
- BunkerHill Health: 1 (https://510kreport.com/company/bunkerhill-health)
- Medical AI Co., Ltd.: 1 (https://510kreport.com/company/medical-ai)

## Its most-cited devices
- K232699: Low Ejection Fraction AI-ECG Algorithm (2023), cited by 4
- K250652: ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010) (2025), cited by 3
- K252360: ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020) (2026), cited by 1

## Recent decisions
- K260300: WatchMate Software (Jun 15, 2026)
- K253801: ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040) (Apr 7, 2026)
- K252360: ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020) (Mar 28, 2026)
- K250652: ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010) (Jul 28, 2025)
- K233160: NeuTrace EP Mapping System v.2.1 (Nov 25, 2023)
- K232699: Low Ejection Fraction AI-ECG Algorithm (Sep 28, 2023)

Source page: https://510kreport.com/company/anumana