DeepRhythmAI
FDA 510(k)FDA UDIClass II (US FDA 510(k))
Identity
- Trade Name
- DeepRhythmAI FDA UDI
- Generic Name
- Cardiopulmonary physiological parameter analysis software FDA UDI
- Device Name
- The DeepRhythmAI (DRAI) is a cloud-based software for automated analysis of ECG data. It uses a scalable Application Programming Interface (API) to enable easy integration. The main component of DeepRhythmAI is an automated proprietary deep-learning algorithm, which measures and analyzes ECG data to provide qualified healthcare professional with supportive information for review. DeepRhythmAI can be integrated into medical devices. FDA UDI
- Model / Reference
- Type: DRAI FDA UDI
- Description
- The DeepRhythmAI (DRAI) is a cloud-based software for automated analysis of ECG data. It uses a scalable Application Programming Interface (API) to enable easy integration. The main component of DeepRhythmAI is an automated proprietary deep-learning algorithm, which measures and analyzes ECG data to provide qualified healthcare professional with supportive information for review. DeepRhythmAI can be integrated into medical devices. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05903021560131 FDA UDI
- FDA Product Code
- DQK FDA 510(k)FDA UDIDPS FDA UDIQYX FDA UDI
- GMDN Term
- Cardiopulmonary physiological parameter analysis software FDA UDI
Classification
- Device Class
- Class II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 870.1425 FDA 510(k)
- Regulation Number
- 870.1425 FDA 510(k)FDA UDI870.2340 FDA UDI870.1025 FDA UDI
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
DeepRhythmAI is a software-as-a-medical-device (SaMD) designed for the analysis and interpretation of cardiac rhythm data, specifically for detecting and classifying arrhythmias. It leverages artificial intelligence algorithms to assist clinicians in diagnosing conditions such as atrial fibrillation, ventricular tachycardia, and other cardiac arrhythmias by processing electrocardiogram (ECG) signals.
The device is intended for use in clinical settings, including hospitals, electrophysiology labs, and cardiology clinics, where ECG data is generated. Supplied as a digital platform, it operates on compatible electronic health record (EHR) systems or standalone ECG devices, requiring no physical sterilisation or single-use considerations. Authorised under FDA 510(k) clearance (K241197) as substantially equivalent to a predicate device, it adheres to regulatory standards for SaMD under the Cardiovascular advisory committee classification.
Frequently asked questions
What types of cardiac arrhythmias does DeepRhythmAI help diagnose, and how does it work?
DeepRhythmAI is designed to detect and classify specific arrhythmias, including atrial fibrillation and ventricular tachycardia, by analyzing ECG signals. It uses artificial intelligence algorithms to interpret cardiac rhythm data, assisting clinicians in diagnosing these conditions more efficiently. The software processes ECG data from electronic health record systems or standalone ECG devices, providing automated insights to support clinical decision-making.
Is DeepRhythmAI a physical device that requires sterilization, or is it a digital platform?
DeepRhythmAI is a software-as-a-medical-device (SaMD) and does not require physical sterilization or single-use considerations. It operates as a digital platform integrated with compatible electronic health record (EHR) systems or standalone ECG devices, meaning no physical packaging or sterilization processes are involved.
How is DeepRhythmAI authorized for use in the U.S., and what regulatory pathway was followed?
DeepRhythmAI received FDA 510(k) clearance (K241197) under the traditional review pathway, determined to be *substantially equivalent* to a predicate device. The authorization was classified under the Cardiovascular advisory committee (CV), ensuring compliance with regulatory standards for SaMD intended for arrhythmia analysis.
Can DeepRhythmAI be used with any ECG device, or does it require specific equipment?
DeepRhythmAI is designed to operate on compatible electronic health record (EHR) systems or standalone ECG devices, meaning it integrates with existing clinical infrastructure. While it is not limited to a single brand, compatibility depends on the device’s ability to generate ECG data in a format the software can process—check with Medicalgorithmics for specific device compatibility lists.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K210822 | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K241197 | Class II | Active |
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Manufacturer
- Manufacturer
- Medicalgorithmics S.A.
Sources (3)
- FDA 510(k) K241197 24 fields · synced Sep 18, 2026
- FDA 510(k) K210822 24 fields · synced May 18, 2026
- FDA UDI b1f49c65-d9f2-4599-bc04-78d4f5a26b4b 34 fields · synced May 27, 2026