FDA.reportPublic FDA data

DeepRhythm Platform

Primary DI
05903021560698
Brand
DeepRhythm Platform
Company
MEDICALGORITHMICS S A
Model
DeepRhythm Platform
Device description
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.
Published
2024-12-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
DPSElectrocardiograph
DQKComputer, Diagnostic, Programmable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DPSElectrocardiographCardiovascular2
DQKComputer, Diagnostic, ProgrammableCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K232161000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232161000DeepRhythm PlatformMedicalgorithmics S.A.2024-06-20DPS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05903021560698PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05903021560698059030215606985903021560698

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiographic long-term ambulatory recording analyser application softwareA dedicated application data program designed for use in, or together with, an electrocardiographic long-term ambulatory recording analyser so that this may function according to its intended purpose. This software program can be permanently installed, or exchanged as an upgrade. It may also be produced for installation in an off-the-shelf desktop or laptop computer.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
522657576
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05903021560834DeepRhythmAIType: DRAI2026-03-25
05903021560742DeepRhythmAIType: DRAI2025-06-06
05903021560223PocketECG IV - Unified Arrhythmia Diagnostic SystemP3HL-AB-UNI2025-12-04
05903021560001Medicalgorithmics Unified Arrhythmia Diagnostic System PocketECGType: PC Client2017-12-18
05903021560131DeepRhythmAIType: DRAI2022-08-05
05903021560018PocketECG III – Medicalgorithmics Unified Arrhythmia Diagnostic SystemType: PECGT-III2018-01-09
05903021560025PocketECG III – Medicalgorithmics Unified Arrhythmia Diagnostic SystemType: PECGT-IIIV2018-01-09
05903021560032PocketECG III – Medicalgorithmics Unified Arrhythmia Diagnostic SystemType: PECGB-III2018-01-09
05903021560049PocketECG III – Medicalgorithmics Unified Arrhythmia Diagnostic SystemType: PECGC-III2018-01-09
05903021560056PocketECG CRS - Medicalgorithmics Unified Cardiac Rehabilitation SystemType: PECGT-IIIR2018-08-21
05903021560124Q PatchP5HP-AA-ADS2022-06-23
05903021560155Q Patch Mobile Application1.02022-06-23
05903021560162Q Patch Downloader9.482022-06-23
05903021560070PocketECG IV – Unified Arrhythmia Diagnostic SystemP4TR-AA-ADS2020-08-14
05903021560087PocketECG IV – Unified Arrhythmia Diagnostic SystemP4TR-AB-ADS2020-08-14
05903021560094PocketECG IV – Unified Arrhythmia Diagnostic SystemP4BA-AA-UNI2020-08-14
05903021560100PocketECG IV – Unified Arrhythmia Diagnostic SystemP3CH-AB-UNI2020-08-14
05903021560117PocketECG IV – Unified Arrhythmia Diagnostic SystemP4BA-AB-UNI2020-08-14
05903021560063PocketECG III – Medicalgorithmics Unified Arrhythmia Diagnostic SystemType: PECGH-III2018-08-21

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