FDA.reportPublic FDA data

Zio ECG Utilization Software (ZEUS) System

Primary DI
00850043907046
Brand
Zio ECG Utilization Software (ZEUS) System
Company
IRHYTHM TECHNOLOGIES, INC.
Model
FG0401US
Published
2024-07-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
DQKComputer, Diagnostic, Programmable
DSIDetector And Alarm, Arrhythmia
DXHTransmitters And Receivers, Electrocardiograph, Telephone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQKComputer, Diagnostic, ProgrammableCardiovascular2
DSIDetector And Alarm, ArrhythmiaCardiovascular2
DXHTransmitters And Receivers, Electrocardiograph, TelephoneCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K202527000
K222389000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202527000Zio ECG Utilization Software (ZEUS) SystemiRhythm Technologies, Inc.2021-05-21DQK
K222389000ZEUS SystemiRhythm Technologies, Inc.2023-02-15DQK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850043907046PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850043907046008500439070468500439070460850043907046

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac electrophysiology processing softwareA software program designed to add specific image processing and/or data analysis capabilities to a computer for the interpretation and/or screening of cardiac electrophysiology parameters [e.g., electrocardiogram (ECG)]. It is intended for use exclusively by healthcare professionals and may provide risk assessment for cardiac events [e.g., acute myocardial infarction (AMI), acute myocardial ischemic injury (AMII)] or screen for specific conditions (e.g., low ejection fraction). It might include artificial intelligence (AI) and machine learning (ML) technology.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
861237670
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00869770000241Zio monitorDFG00012022-05-03
00869770000210ZIO AT PatchA100A100X2019-04-23
00869770000203ZIO XT PatchN100A102X2016-09-19
00869770000234ZIO SR PatchK100A101X2016-09-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850086928008SENSINEL™ CPM BASE STATIONAnalog Devices, Inc.DXH2026-06-03
00850086928015SENSINEL™ CPM WEARABLEAnalog Devices, Inc.DXH2026-06-03
00850086928022SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.DXH2026-06-03
00850086928039SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.DXH2026-06-03
05415067055811EnSite™ST. JUDE MEDICAL, INC.DQK2026-06-01
08719689142124QMAPP Fysicon B.V.DQK2026-05-19
08719689142131QMAPP Fysicon B.V.DQK2026-05-19
08719689142162QMAPP Fysicon B.V.DQK2026-05-19
08719689142179QMAPP Fysicon B.V.DQK2026-05-19
08800069700109AT-ReportATsens Co., Ltd.DQK2025-11-05
08800069700246ATACC-C130AATsens Co., Ltd.DQK2025-11-05
08800069700260AT-PatchATsens Co., Ltd.DQK2025-11-05
08800069700277AT-PatchATsens Co., Ltd.DQK2025-11-05
08908013617128Frontier X PlusFOURTH FRONTIER TECHNOLOGIES PRIVATE LIMITEDDXH2025-02-07
G637CEA0Cardiologs PlatformPHILIPS FRANCEDQK2024-09-23
08800069700178AT-PatchATsens Co., Ltd.DQK2022-12-23
08714729982845MDU5 PLUSBOSTON SCIENTIFIC CORPORATIONDQK2021-11-29
08714729982852MDU5 PLUSBOSTON SCIENTIFIC CORPORATIONDQK2021-11-29
08714729982876MDU5 PLUSBOSTON SCIENTIFIC CORPORATIONDQK2021-11-29
08714729996545AVVIGO™ Guidance SystemBOSTON SCIENTIFIC CORPORATIONDQK2020-08-17
08714729996552AVVIGO™ Guidance SystemBOSTON SCIENTIFIC CORPORATIONDQK2020-08-17
08437011759092Nuubo SystemSMART SOLUTIONS TECHNOLOGIES SLDQK2019-11-20
08714729986089IBP Cable KitBOSTON SCIENTIFIC CORPORATIONDQK2018-11-15
10841522124563PathfinderSPACELABS HEALTHCARE (WASHINGTON), INCDXH2018-08-03
10841522124563PathfinderSPACELABS HEALTHCARE (WASHINGTON), INCDQK2018-08-03
10841522125645PathfinderSPACELABS HEALTHCARE (WASHINGTON), INCDXH2018-08-03
10841522125010PathfinderSLSPACELABS HEALTHCARE (WASHINGTON), INCDQK2018-06-19
10841522125027PathfinderSLSPACELABS HEALTHCARE (WASHINGTON), INCDQK2018-06-19
10841522125034PathfinderSLSPACELABS HEALTHCARE (WASHINGTON), INCDQK2018-06-19
10841522125041PathfinderSLSPACELABS HEALTHCARE (WASHINGTON), INCDQK2018-06-19