FDA.reportPublic FDA data

KODEX-EPD System

Primary DI
00884838095229
Brand
KODEX-EPD System
Company
Philips Medical Systems Nederland B.V.
Model
733015
Device description
The KODEX-EPD™ System is indicated for catheter-based cardiac electrophysiological (EP)procedures. The KODEX-EPD™ System provides information about the electrical activity of theheart and about catheter location during the procedure. The system can be used on patients who areeligible for a conventional electrophysiological procedure.
Published
2021-10-15
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
DQKComputer, Diagnostic, Programmable

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180940000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180940000KODEX EPD SystemPhilips Medical Systems Nederland B.V.2018-10-24DQK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884838095229PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884838095229008848380952298848380952290884838095229

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac mapping system application softwareAn individual software program or group of programs, routines and/or algorithms that add specific image processing and/or analysis capabilities to a cardiac mapping system computer for storing, processing and management of electronic information/data used to interpret cardiac physiology parameters. It is a basic set of application programs and routines used for cardiac mapping computer-controlled imaging which can be upgraded to correct programming errors or to add new system capabilities. An application program package is typically identified by a proprietary name and "version" or "upgrade" number.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
413819707
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884838123748Spectral CT VeridaSpectral CT Verida7283452026-05-26
00884838126398Spectral CT Verida RTSpectral CT Verida RT7283572026-05-26
00884838127555Upgrade Spectral CT VeridaUpgrade Spectral CT Verida7283562026-05-26
00884838127562Upgrade Spectral CT Verida RTUpgrade Spectral CT Verida RT7283722026-05-26
00884838127883Upgrades Spectral CT 7500 RT SW5.4Upgrades Spectral CT 7500 RT SW5.47283552026-05-26
00884838119253Spectral CT System UpgradesSpectral CT System Upgrades7283352025-05-25
00884838101111Spectral CTSpectral CT7283332021-03-11
00884838123786Multimodality Simulation Workspace (MM Sim)1.0Multimodality Simulation Workspace (MM Sim)1.07283492026-06-07
00884838123793Multimodality Simulation Workspace (MM Sim)1.0 UpgradeMultimodality Simulation Workspace (MM Sim)1.0 Upg7283512026-06-07
00884838127876Upgrade Spectral CT 7500 SW5.4Upgrade Spectral CT 7500 SW5.47283752026-05-26
00884838128187IngeniaBlueSeal SE7822132026-04-07
00884838128194IngeniaBlueSeal XE7822142026-04-07
00884838128200IngeniaIngenia Elition S7822162026-04-07
00884838128217IngeniaIngenia Elition X7822172026-04-07
00884838128224MR 7700MR 77007822182026-04-07
00884838128231IngeniaUpgrades dStream to R137822192026-04-07
00884838128248IngeniaEvolution Upgrade 1.5T7822202026-04-07
00884838128255IngeniaEvolution Upgrade 3.0T7822212026-04-07
00884838128262IngeniaSmartPath to Ingenia Elition X7822222026-04-07
00884838128293MR 7700Upgrade to MR 77007822252026-04-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00885403532040FloTracBecton, Dickinson And CompanyDQK2026-07-31
09349714010877MICROPACE PTY LIMITEDMICROPACE PTY LIMITEDDQK2026-07-21
17540262100150Change Healthcare Cardiology HemoChange Healthcare Canada CompanyDQK2026-07-21
17540262110166Change Healthcare Cardiology ECG ManagementChange Healthcare Canada CompanyDQK2026-07-21
17540262170054Change Healthcare Cardiology HemodynamicsChange Healthcare Canada CompanyDQK2026-07-21
00884838118898IECGPhilips Medizin Systeme Böblingen GmbHDQK2026-06-23
05415067055811EnSite™ST. JUDE MEDICAL, INC.DQK2026-06-01
00854277008197NorthStar Mapping SystemImricor Medical Systems, Inc.DQK2026-05-21
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
17540279200027CardioSTATIcentia Inc.DQK2025-12-08
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
B353UA2251DA1UbiqVueLifesignals, Inc.DQK2025-04-22
B353UA2251SA1UbiqVueLifesignals, Inc.DQK2025-04-22
27540279250029CardioSTATIcentia Inc.DQK2024-12-18
27540279250074CardioSTATIcentia Inc.DQK2024-12-18
27540279250142CardioSTATIcentia Inc.DQK2024-12-18
G637CEA0Cardiologs PlatformPHILIPS FRANCEDQK2024-09-23
17540279105018EARTIcentia Inc.DQK2024-03-26
17540279200072CardioSTATIcentia Inc.DQK2024-03-26
17540279200140CardioSTATIcentia Inc.DQK2024-03-26
17540262170016Change Healthcare Cardiology HemodynamicsChange Healthcare Canada CompanyDQK2023-09-19
08800069700178AT-PatchATsens Co., Ltd.DQK2022-12-23
08714729982845MDU5 PLUSBOSTON SCIENTIFIC CORPORATIONDQK2021-11-29
08714729982852MDU5 PLUSBOSTON SCIENTIFIC CORPORATIONDQK2021-11-29