DeepRhythm Platform

GUDID 05903021560698

The DeepRhythm Platform is a modern cloud-based software system with microservice architecture and a browser-based user interface. It provides a comprehensive arrhythmia diagnosis process and monitoring session management capabilities, which consist of: • enrolling a patient for an ECG monitoring session in a medical facility, • receiving the signal from a compatible monitoring device worn by the patient, • using an external AI service for signal analysis and classification, • processing signal and annotations received from the external AI service, including statistics computation, • reviewing the signal and annotations by an ECG Technician, • generating and publishing reports for single ECG episodes and the entire monitoring session as well, • reviewing published reports back at the medical facility that ordered the monitoring session in the first place.

MEDICALGORITHMICS S A

Electrocardiographic long-term ambulatory recording analyser application software

• Primary Device ID: 05903021560698
• NIH Device Record Key: 75f8c4e3-1c3b-40ae-8ca1-955f6e15b77b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DeepRhythm Platform
• Version Model Number: DeepRhythm Platform
• 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	05903021560698 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232161

FDA Product Code

• DPS: Electrocardiograph

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: 2024-12-30
• Device Publish Date: 2024-12-20

Devices Manufactured by MEDICALGORITHMICS S A

• 05903021560698 - DeepRhythm Platform: 2024-12-30The DeepRhythm Platform is a modern cloud-based software system with microservice architecture and a browser-based user interface. It provides a comprehensive arrhythmia diagnosis process and monitoring session management capabilities, which consist of: • enrolling a patient for an ECG monitoring session in a medical facility, • receiving the signal from a compatible monitoring device worn by the patient, • using an external AI service for signal analysis and classification, • processing signal and annotations received from the external AI service, including statistics computation, • reviewing the signal and annotations by an ECG Technician, • generating and publishing reports for single ECG episodes and the entire monitoring session as well, • reviewing published reports back at the medical facility that ordered the monitoring session in the first place.
• 05903021560698 - DeepRhythm Platform: 2024-12-30 The DeepRhythm Platform is a modern cloud-based software system with microservice architecture and a browser-based user interfac
• 05903021560131 - DeepRhythmAI: 2022-08-15 The DeepRhythmAI (DRAI) is a cloud-based software for automated analysis of ECG data. It uses a scalable Application Programming
• 05903021560124 - Q Patch: 2022-07-01 The Q Patch is a single channel ECG recorder. The device is intended to be placed on the sternum (in the middle of the chest). T
• 05903021560155 - Q Patch Mobile Application: 2022-07-01 Q Patch Mobile Application (Mobile application) – The Q Patch Mobile Application is intended to be used for interacting with t
• 05903021560162 - Q Patch Downloader: 2022-07-01 Q Patch Downloader (PC application) – The intended use of the Q Patch Downloader application is to download the data from comp
• 05903021560070 - PocketECG IV – Unified Arrhythmia Diagnostic System: 2020-08-24 The PocketECG transmitter is a key component of PocketECG IV - Unified Arrhythmia Diagnostic System and is intended to: acquire,
• 05903021560087 - PocketECG IV – Unified Arrhythmia Diagnostic System: 2020-08-24 The PocketECG transmitter is a key component of PocketECG IV - Unified Arrhythmia Diagnostic System and is intended to: acquire,
• 05903021560094 - PocketECG IV – Unified Arrhythmia Diagnostic System: 2020-08-24 The battery type P4BA-AA-UNI is an accessory to the PocketECG IV - Unified Arrhythmia Diagnostic System. The battery is intended