FDA.reportPublic FDA data

iMap 3D Mapping and Navigation System

Primary DI
00850012226291
Brand
iMap 3D Mapping and Navigation System
Company
Cardionxt Inc
Model
820000
Published
2025-12-10
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

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K201094000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201094000iMap 3D Mapping & Navigation System (iMap System)Cardionxt, Inc.2021-08-16DQK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850012226291PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850012226291008500122262918500122262910850012226291

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac mapping systemAn assembly of devices designed to measure, process, and store electronic data for the interpretation of cardiac physiological parameters received from the output of connected measuring devices (e.g., body surface or intracardiac electrocardiograph (ECG) sensors, transducers, and catheters). The measurements can be compared to pre-established diagnostic criteria for parameters such as cardiac blood flow, electrical conduction, or heart chamber geometry. It typically consists of dedicated workstation, hardware and software that display real-time, three-dimensional (3-D) cardiac maps (e.g., electrical propagation, electrical potential, and cardiac chamber geometry maps), and a catheter.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
117364041
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850012226338iMap Software8205012026-04-09
00850012226406iMap Computer Cart8255002026-04-09
00850012226000Axis Patient Patches8210102025-12-10
00850012226154Multilink CS Catheter8210032025-12-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00199874185187Vektor Medical vMap SoftwareVektor Medical, Inc.DQK2026-05-08
00195278620873MACGe Medical Systems Information Technologies, Inc.DQK2026-03-31
00195278507037Mac-LabGe Medical Systems Information Technologies, Inc.DQK2026-03-26
00198953107263MACGe Medical Systems Information Technologies, Inc.DQK2026-01-27
00191506052454MDU5 Plus™BOSTON SCIENTIFIC CORPORATIONDQK2025-12-09
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
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
00191506033002AVVIGO™+BOSTON SCIENTIFIC CORPORATIONDQK2023-10-10
00191506033125AVVIGO™+BOSTON SCIENTIFIC CORPORATIONDQK2023-10-10
00191506033194AVVIGO™+BOSTON SCIENTIFIC CORPORATIONDQK2023-10-10
00191506033200AVVIGO™+BOSTON SCIENTIFIC CORPORATIONDQK2023-10-10
17540262170016Change Healthcare Cardiology HemodynamicsChange Healthcare Canada CompanyDQK2023-09-19
00195278522313CARESCAPE Canvas Smart DisplayGE Healthcare Finland OyDQK2023-04-19
00195278522320CARESCAPE Canvas 1000GE Healthcare Finland OyDQK2023-04-19
00195278523365CARESCAPE Canvas D19GE Healthcare Finland OyDQK2023-04-19