# Medicalgorithmics S.A.

- Location (FDA's records): Warsaw, PL
- FDA decisions: 11 (2012–2025): 11 510(k) clearances
- Product codes: DSI (5), DQK (4), DPS (1), MWJ (1)
- 510(k) review time since 2016: median 277 days, against 118 for FDA's reviews in the same codes and years (2 of 6 faster)
- Predicates its devices cite: 19 (7 its own); citations of its devices by later devices: 13 (7 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
- Biofourmis Singapore Pte., Ltd.: 2 (https://510kreport.com/company/biofourmis-singapore)
- Cardionet, Inc.: 2 (https://510kreport.com/company/cardionet)
- Universal Medical, Inc.: 2 (https://510kreport.com/company/universal-medical)
- Ge Medical Systems Information Technologies: 2 (https://510kreport.com/company/ge-medical-systems-information-technologies)
- Cardiologs Technologies: 1 (https://510kreport.com/company/cardiologs-technologies)
- iRhythm Technologies, Inc.: 1 (https://510kreport.com/company/irhythm-technologies)
- Quinton Cardiology, Inc.: 1 (https://510kreport.com/company/quinton-cardiology)
- Dms-Service, LLC: 1 (https://510kreport.com/company/dms-service)

## Firms that cite its devices most
- VivaQuant, Inc.: 1 (https://510kreport.com/company/vivaquant)
- Vitalconnect, Inc.: 1 (https://510kreport.com/company/vitalconnect)
- Synergen Technology Labs, LLC: 1 (https://510kreport.com/company/synergen-technology-labs)
- B-Secur Limited: 1 (https://510kreport.com/company/b-secur)
- Zywie, Inc.: 1 (https://510kreport.com/company/zywie)
- Wellysis Corp.: 1 (https://510kreport.com/company/wellysis)

## Its most-cited devices
- K210822: DeepRhythmAI (2022), cited by 3
- K152550: Medicalgorithmics Unified Arrhythmia Diagnosic System (2015), cited by 2
- K112921: Medicalgorithmics Unified Arrhythmia Diagnostic System (2012), cited by 2
- K124060: Medical Gorithmics Unified Arrhythmia Diagnostic System (2013), cited by 2
- K241197: DeepRhythmAI (2024), cited by 2
- K250932: DeepRhythmAI (2025), cited by 1

## Recent decisions
- K253141: DeepRhythmAI (Dec 11, 2025)
- K250932: DeepRhythmAI (May 27, 2025)
- K241197: DeepRhythmAI (Dec 4, 2024)
- K232161: DeepRhythm Platform (Jun 20, 2024)
- K210822: DeepRhythmAI (Jul 27, 2022)
- K210758: Q Patch (Jun 2, 2022)
- K193104: Unified Arrhythmia Diagnostic System PocketECG IV (Apr 9, 2020)
- K173969: Medicalgorithmics Unified Cardiac Rehabilitation System (Jul 11, 2018)

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