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DeepRhythm Platform

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K232161

by Medicalgorithmics S.A.

Identifiers

510(k) Number
K232161 FDA 510(k)
FDA Product Code
DPS FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.2340 FDA 510(k)
Regulation Number
870.2340 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The DeepRhythm Platform is a hardware-agnostic cloud-based software system designed for the detection, classification, and analysis of electrocardiogram (ECG) data using deep learning algorithms. It leverages advanced AI techniques, including convolutional neural networks and transformer models, to identify and assess cardiac arrhythmias with high diagnostic precision.

This platform is supplied as a cloud-based solution, intended for use in clinical settings by healthcare professionals for remote monitoring and automated ECG analysis. It is classified under the product code DPS and has received FDA 510(k) clearance and MDR authorization. The system is not single-use but is designed for repeated use within a regulated healthcare environment, with no specific sterility or MRI safety requirements stated.

Frequently asked questions

What types of cardiac conditions can the DeepRhythm Platform detect and analyze using ECG data?

The DeepRhythm Platform uses deep learning algorithms, including convolutional neural networks and transformer models, to detect and classify cardiac arrhythmias. While the exact arrhythmias aren’t listed, its design focuses on automated ECG analysis for remote monitoring, allowing healthcare professionals to identify and assess abnormal heart rhythms with high diagnostic precision.

Is the DeepRhythm Platform intended for single-use or repeated use in clinical settings?

The DeepRhythm Platform is designed for repeated use within a regulated healthcare environment. Since it is a cloud-based software system, it does not require sterility or single-use considerations like traditional medical devices.

How is the DeepRhythm Platform supplied, and what kind of setup is required for use?

The DeepRhythm Platform is supplied as a cloud-based solution, meaning it does not require physical hardware installation at the point of care. Instead, it integrates with existing ECG devices (hardware-agnostic) to transmit data for remote analysis, making it accessible via a network connection in clinical settings.

What regulatory pathways has the DeepRhythm Platform undergone, and which committees were involved?

The DeepRhythm Platform has received FDA 510(k) clearance through a traditional review process, classified under product code DPS (Diagnostic, Patient-Monitored, Non-Powered). The submission was reviewed by the FDA’s Cardiovascular (CV) Advisory Committee, with a decision date of June 20, 2024. It has also obtained MDR authorization.

Does the DeepRhythm Platform have any special storage or handling requirements beyond standard IT security?

As a cloud-based system, the primary storage and handling requirements align with standard healthcare IT security protocols to ensure data integrity and confidentiality. No specific sterility or physical storage conditions (e.g., temperature, humidity) are mentioned, as the platform operates remotely without physical device components.

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, Medicalgorithmics, DeepRhythm Platform, DeepRhythmAI by Medicalgorithmics | Cardiac AI for Physicians ...

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Medicalgorithmics S.A.

Sources (2)

  • FDA 510(k) K232161 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced Jun 18, 2026