DeepRhythmAI

GUDID 05903021560742

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.

MEDICALGORITHMICS S A

Cardiopulmonary physiological parameter analysis software

• Primary Device ID: 05903021560742
• NIH Device Record Key: 0d1ee285-4130-4f04-be56-71a72cb7b04b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DeepRhythmAI
• Version Model Number: Type: DRAI
• Company DUNS: 522657576
• Company Name: MEDICALGORITHMICS S A
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05903021560742 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K250932

FDA Product Code

• DQK: Computer, Diagnostic, Programmable

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-06-16
• Device Publish Date: 2025-06-06

On-Brand Devices [DeepRhythmAI]

• 05903021560131: The DeepRhythmAI (DRAI) is a cloud-based software for automated analysis of ECG data. It uses a
• 05903021560742: DeepRhythmAI is a cloud-based software that utilizes AI algorithms to assess cardiac arrhythmias