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DeepRhythmAI

FDA 510(k)

Class II (US FDA 510(k))

510(k) K250932

by Medicalgorithmics S.A.

Identifiers

510(k) Number
K250932 FDA 510(k)
FDA Product Code
DQK FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.1425 FDA 510(k)
Regulation Number
870.1425 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

DeepRhythmAI is an artificial intelligence solution designed to enhance the accuracy and efficiency of cardiac arrhythmia detection. It analyses ambulatory ECGs with exceptional attention to detail, supporting remote cardiac monitoring.

DeepRhythmAI is a cloud-based device intended for use in cardiac diagnostics. It is supplied as a software solution and is not reusable. The device is not specified as sterile, and no storage conditions are provided.

Frequently asked questions

What is DeepRhythmAI used for?

DeepRhythmAI is an artificial intelligence solution designed to enhance the accuracy and efficiency of cardiac arrhythmia detection by analysing ambulatory ECGs with exceptional attention to detail, supporting remote cardiac monitoring.

How is DeepRhythmAI supplied and is it reusable?

DeepRhythmAI is supplied as a cloud-based software solution and is not reusable, as it is intended for use in cardiac diagnostics through remote analysis of ambulatory ECG data.

Does DeepRhythmAI require sterilization or have specific storage conditions?

DeepRhythmAI is not specified as sterile, and no storage conditions are provided in the device data, as it is a software solution delivered via cloud infrastructure rather than a physical implant or reusable hardware.

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: Medicalgorithmics expands the reach of DeepRhythmAI to a rapidly ..., DRAI MARTINI - Medicalgorithmics, DeepRhythmAI by Medicalgorithmics | Cardiac AI for Physicians ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Medicalgorithmics S.A.

Sources (1)

  • FDA 510(k) K250932 24 fields · synced Oct 1, 2026