FDA.reportPublic FDA data

DeepRhythmAI

Primary DI
05903021560131
Brand
DeepRhythmAI
Company
MEDICALGORITHMICS S A
Model
Type: DRAI
Device description
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.
Published
2022-08-05
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
DPSElectrocardiograph
DQKComputer, Diagnostic, Programmable
QYXOutpatient Cardiac Telemetry

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DPSElectrocardiographCardiovascular2
DQKComputer, Diagnostic, ProgrammableCardiovascular2
QYXOutpatient Cardiac TelemetryCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K210822000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K210822000DeepRhythmAIMedicalgorithmics S.A.2022-07-27DQK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05903021560131PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05903021560131059030215601315903021560131

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
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
05903021560698DeepRhythm PlatformDeepRhythm Platform2024-12-20
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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Primary DI, Brand, Company table
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00850086928022SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.DPS2026-06-03
00850086928039SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.DPS2026-06-03
05415067055811EnSite™ST. JUDE MEDICAL, INC.DQK2026-06-01
B3944060056010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DPS2026-05-27
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