DeepRhythmAI
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- DeepRhythmAI EUDAMEDFDA UDI
- Generic Name
- Cardiopulmonary physiological parameter analysis software FDA UDI
- Device Name
- DeepRhythmAI EUDAMEDDeepRhythmAI is a cloud-based software that utilizes AI algorithms to assess cardiac arrhythmias using a single- or two-lead ECG data from adult patients. It is intended for use by a healthcare solution integrator to build web, mobile or another types of applications to let qualified healthcare professionals review and confirm the analytic result. The product supports downloading and analyzing data recorded in the compatible formats from ECG devices such as Holter, Event recorder, Outpatient Cardiac Telemetry devices or other similar recorders when the assessment of the rhythm is necessary. The product can be electronically interfaced and perform analysis with data transferred from other computer-based ECG systems, such as an ECG management system. DeepRhythmAI can be integrated into medical devices. In this case, the medical device manufacturer will identify the indication for use depending on the application of their device. DeepRhythmAI is not for use in life-supporting or sustaining systems or ECG Alarm devices. Interpretation results are not intended to be the sole means of diagnosis. It is offered to physicians and clinicians on an advisory basis only in conjunction with the physician's knowledge of ECG patterns, patient background, clinical history, symptoms and other diagnostic information. FDA UDI
- Model / Reference
- 05903021560742 EUDAMEDType: DRAI FDA UDI
- Description
- DeepRhythmAI is a cloud-based software that utilizes AI algorithms to assess cardiac arrhythmias using a single- or two-lead ECG data from adult patients. It is intended for use by a healthcare solution integrator to build web, mobile or another types of applications to let qualified healthcare professionals review and confirm the analytic result. The product supports downloading and analyzing data recorded in the compatible formats from ECG devices such as Holter, Event recorder, Outpatient Cardiac Telemetry devices or other similar recorders when the assessment of the rhythm is necessary. The product can be electronically interfaced and perform analysis with data transferred from other computer-based ECG systems, such as an ECG management system. DeepRhythmAI can be integrated into medical devices. In this case, the medical device manufacturer will identify the indication for use depending on the application of their device. DeepRhythmAI is not for use in life-supporting or sustaining systems or ECG Alarm devices. Interpretation results are not intended to be the sole means of diagnosis. It is offered to physicians and clinicians on an advisory basis only in conjunction with the physician's knowledge of ECG patterns, patient background, clinical history, symptoms and other diagnostic information. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05903021560742 EUDAMEDFDA UDI
- Basic UDI-DI
- 590302156DRAI23K EUDAMED
- FDA Product Code
- DQK FDA 510(k)FDA UDIDPS FDA UDIQYX FDA UDI
- EMDN Code
- Z129092 VARIOUS INSTRUMENTS FOR FUNCTIONAL EXPLORATION AND THERAPEUTIC INTERVENTIONS - MEDICAL DEVICE SOFTWARE EUDAMED
- GMDN Term
- Cardiopulmonary physiological parameter analysis software FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass 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
- Special Device Type
- Software EUDAMED
- 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
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
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 set of deep learning-based algorithms for automated analysis of electrocardiogram (ECG) data, designed to detect and classify cardiac arrhythmias. It leverages advanced machine learning techniques, including convolutional neural networks and transformer models, to enhance diagnostic accuracy and efficiency in cardiac rhythm assessment.
DeepRhythmAI is supplied as a cloud-based software solution, intended for integration with third-party ECG devices and software platforms. It is classified as substantially equivalent under FDA 510(k) clearance (K253141) and meets MDR requirements, with no third-party involvement in its regulatory submission. The system is not single-use or reusable but operates as a standalone analytical tool, requiring no physical storage or sterilisation.
Frequently asked questions
How does DeepRhythmAI integrate with existing ECG systems, and what types of third-party devices does it support?
DeepRhythmAI is designed as a cloud-based software solution that connects with third-party ECG devices and platforms, enabling automated analysis of ECG data. While the exact supported devices aren’t specified, its deep learning algorithms (including convolutional neural networks and transformers) are intended to work with standard ECG inputs, making it adaptable to most modern cardiac monitoring systems. Always verify compatibility with your specific ECG hardware or software before integration.
Is DeepRhythmAI a standalone tool, or does it require additional hardware to function?
DeepRhythmAI operates as a standalone analytical tool and does not require any physical hardware beyond the third-party ECG devices it connects to. It runs entirely in the cloud, meaning no local installation, storage, or sterilization is needed. The system processes ECG data remotely, providing automated arrhythmia detection and classification without additional equipment.
What types of cardiac arrhythmias can DeepRhythmAI detect and classify, and how does its deep learning approach improve accuracy?
DeepRhythmAI uses advanced machine learning—including convolutional neural networks and transformer models—to analyze ECG data for automated detection and classification of cardiac arrhythmias. While the exact arrhythmias it identifies aren’t detailed, its deep learning architecture is designed to enhance diagnostic precision by recognizing complex patterns in ECG signals that may be missed by traditional algorithms. This approach aims to improve efficiency and accuracy in cardiac rhythm assessment.
How is DeepRhythmAI regulated, and what does its FDA 510(k) clearance and MDR compliance mean for users?
DeepRhythmAI holds an FDA 510(k) clearance (K253141) under the *Substantially Equivalent* classification, meaning it was determined to have the same intended purpose and technological characteristics as a legally marketed predicate device in the cardiovascular category. It also complies with the EU’s Medical Device Regulation (MDR), with no third-party involvement in its regulatory submission. This ensures it meets stringent safety and performance standards for automated ECG analysis, though users should always consult the latest regulatory documentation for full details.
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. Sources consulted: DRAI - Medicalgorithmics, DeepRhythmAI by Medicalgorithmics | Cardiac AI for Physicians ..., Medicalgorithmics
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K253141 | Class II | Active |
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Manufacturer
- Manufacturer
- Medicalgorithmics S.A.
Sources (3)
- FDA 510(k) K253141 24 fields · synced Sep 18, 2026
- FDA UDI 0d1ee285-4130-4f04-be56-71a72cb7b04b 34 fields · synced May 30, 2026
- EUDAMED 84aef4bf-bc1b-46f9-9454-ba0bd7c2cebb 61 fields · synced Jul 28, 2026