DeepRhythmAI

GUDID 05903021560131

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.

MEDICALGORITHMICS S A

Electrocardiographic long-term ambulatory recording analyser application software

• Primary Device ID: 05903021560131
• NIH Device Record Key: b1f49c65-d9f2-4599-bc04-78d4f5a26b4b
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05903021560131 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210822

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: 2022-08-15
• Device Publish Date: 2022-08-05

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