FDA.reportPublic FDA data

EP navigator

Primary DI
00884838059184
Brand
EP navigator
Company
Philips Medical Systems Nederland B.V.
Model
EP navigator - 5
Catalog number
000071
Device description
Software medical device, used with a Philips Interventional X-Ray System. Provides navigation support for cardiovascular devices for heart rhythm disorders.
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
LLZSystem, Image Processing, Radiological
OWBInterventional Fluoroscopic X-Ray System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2
OWBInterventional Fluoroscopic X-Ray SystemRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884838059184PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884838059184008848380591848848380591840884838059184

GMDN Terms#

Term, Definition table
TermDefinition
Cardiovascular fluoroscopy/intravascular imaging softwareA software program intended to display and analyse/process images of the heart and/or blood vessels (e.g., coronary, intracranial, peripheral) acquired during a fluoroscopic x-ray (angiography) and/or intravascular imaging procedure [typically intravascular ultrasound and/or optical coherence tomography (OCT)], to assist with diagnosis, treatment, and/or an implantation procedure [e.g., aortic heart valve replacement, embolization device or stent implantation, by generating computed tomography-like (CT) images via fluoroscopy]. It does not incorporate adaptive/dynamic machine learning (ML) models.

Regulatory Flags#

DUNS number
413819707
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884838127746Radiology Operations Command Center Console18080072025-03-14
00884838122154EchoNavigatorEchoNavigator R5.00010112026-03-25
00884838107557Image Management15.X8390602024-11-15
00884838107571Desktop Diagnostic Viewer15.X8390622024-11-15
00884838107588Web Diagnostic Viewer15.X8390632024-11-15
00884838107595Enterprise Viewer15.X8390642024-11-15
00884838101883Dynamic Coronary RoadmapDynamic Coronary Roadmap - 30010162020-11-10
00884838101890StentBoost LiveStentBoost Live - 20010172020-11-10
00884838106437EchoNavigatorEchoNavigator - 42023-02-10
00884838103504Vue PACS (Web Diagnostic)Vue PACS (Web Diagnostic) - 1289860102021-06-03
00884838085732SmartCTSmartCT - 10010182021-02-25
00884838090668Onvision systemOnvision system4535619434922020-08-07
00884838100336Vue PACSVue PACS - 1289864242020-05-18
00884838100350Vue PACS (Diagnostic)Vue PACS (Diagnostic) - 1211494182020-05-18
00884838100367Vue MotionVue Motion - 1210179792020-05-18
00884838059191Interventional WorkspotInterventional Workspot - 10010002016-09-24
00884838059207HeartNavigatorHeartNavigator - 20010012016-09-24
008848380592213D Roadmap3D Roadmap - 10010032016-09-24
00884838059238MR-CT RoadmapMR-CT Roadmap - 10010042016-09-24
00884838059245Allura 3D-CAAllura 3D-CA - 30010092016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190376649474CONTOUR3DALPHATEC SPINE, INC.OWB2026-09-25
00190376652313CONTOUR3DALPHATEC SPINE, INC.OWB2026-09-25
00190376652320CONTOUR3DALPHATEC SPINE, INC.OWB2026-09-25
00190376652337CONTOUR3DALPHATEC SPINE, INC.OWB2026-09-25
00190376668307CONTOUR3DALPHATEC SPINE, INC.OWB2026-09-25
04260456230215CHILI PACSCHILI GmbHLLZ2026-09-25
B141MEDISSUITEMRCT20260Medis Suite MRCTMedis Medical Imaging Systems B.V.LLZ2026-09-25
BN981BN002020Bolt NavigationCircinus Medical Technology LLCOWB2026-09-25
BN981BN00202BX101Bolt NavigationCircinus Medical Technology LLCOWB2026-09-25
00850025268431Vitrea Advanced VisualizationCanon Medical Informatics, Inc.LLZ2026-09-21
00850079606081MC2 Portable X-ray SystemOXOS Medical, Inc.OWB2026-09-21
00850079606098EmitterOXOS Medical, Inc.OWB2026-09-21
00850079606104CassetteOXOS Medical, Inc.OWB2026-09-21
08437021722109ADAS 3DADAS3D MEDICAL S.L.LLZ2026-09-18
07350092810722Sectra Orthopedic PackageSectra ABLLZ2026-09-06
00754016387128ANDIImeka Solutions IncLLZ2026-05-14
00198953059173ViewPointGE Healthcare GmbHLLZ2026-02-27
00198953076873SenoIrisGE MEDICAL SYSTEMSLLZ2025-11-24
00860003424841OrthoGrid Hip TraumaOrthogrid Systems, Inc.LLZ2025-06-24
00817886020646JointsMEDSTRAT, INC.LLZ2025-04-30
00884838127746Radiology Operations Command Center ConsolePhilips Medical Systems Nederland B.V.LLZ2025-03-14
00817886020639JointsMEDSTRAT, INC.LLZ2025-03-07
00198715251623BrainSpec Core™ SoftwareBrainSpec Inc.LLZ2025-02-10
00817886020622JointsMEDSTRAT, INC.LLZ2025-02-03
00670082000610Modus PlanSynaptive Medical IncLLZ2025-01-17
00817886020615JointsMEDSTRAT, INC.LLZ2024-12-09
00817886020608JointsMEDSTRAT, INC.LLZ2024-11-01
00817886020592JointsMEDSTRAT, INC.LLZ2024-08-31
00195278753472ViewPointGE Healthcare GmbHLLZ2024-07-15
00817886020585JointsMEDSTRAT, INC.LLZ2024-06-08