FDA.reportPublic FDA data

MR-CT Roadmap

Primary DI
00884838059238
Brand
MR-CT Roadmap
Company
Philips Medical Systems Nederland B.V.
Model
MR-CT Roadmap - 1
Catalog number
001004
Device description
Software medical device, used with a Philips Interventional X-Ray System. Extension of 3D-RA. Provides live 3D image guidance for navigating endovascular devices through vascular structures.
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
JAKSystem, X-Ray, Tomography, Computed
LLZSystem, Image Processing, Radiological
OWBInterventional Fluoroscopic X-Ray System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JAKSystem, X-Ray, Tomography, ComputedRadiology2
LLZSystem, Image Processing, RadiologicalRadiology2
OWBInterventional Fluoroscopic X-Ray SystemRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884838059238PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884838059238008848380592388848380592380884838059238

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
00884838120433SmartCTSmartCT - 30010182026-09-28
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
00884838059184EP navigatorEP navigator - 50000712016-09-24
00884838059191Interventional WorkspotInterventional Workspot - 10010002016-09-24
00884838059207HeartNavigatorHeartNavigator - 20010012016-09-24
008848380592213D Roadmap3D Roadmap - 10010032016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198953050996SnapShot FreezeGE Medical Systems, L.L.C.JAK2026-10-19
00198953050996SnapShot FreezeGE Medical Systems, L.L.C.LLZ2026-10-19
03760305400246DUAL SIDED NEEDLE GUIDEQUANTUM SURGICALJAK2026-10-19
03760305400277PATIENT REFERENCE 2.0QUANTUM SURGICALJAK2026-10-19
05745000308385Cercare Medical NeurosuiteCercare Medical A/SLLZ2026-10-17
05745000308392Cercare Medical Neurosuite with Capillary FunctionCercare Medical A/SLLZ2026-10-17
05745000308408Cercare Medical Neurosuite (CMN) Capillary Function with Virtual ExpertCercare Medical A/SLLZ2026-10-17
05745000308361Cercare Oncology Virtual Expert; CMN Capillary Function with Oncology Virtual ExCercare Medical A/SLLZ2026-10-16
75401622502301Synthesis Vision ViewerSynthesis Health Intelligence IncLLZ2026-10-16
00889024713390ROSA® ShoulderOrthosoft IncLLZ2026-10-15
B037FFSMD0Synapse MobilityResolutionMD Inc.LLZ2026-10-15
B037NLIVD0Nicolab Image ViewerResolutionMD Inc.LLZ2026-10-15
B037RESMDD0ResolutionMDResolutionMD Inc.LLZ2026-10-15
00860013868918MICSI-PETMicroStructure Imaging, Inc.LLZ2026-10-14
19356870000045CAC4DMEDICAL LIMITEDJAK2026-10-13
19356870000090LDA4DMEDICAL LIMITEDJAK2026-10-13
00745426000059MiPACS V5Medicor ImagingLLZ2026-10-12
00860016243804C-beamPulmera, Inc.OWB2026-10-10
00860016243804C-beamPulmera, Inc.JAK2026-10-10
75401622522132Synthesis Vision ViewerSynthesis Health Intelligence IncLLZ2026-10-08
00198953200421EchoPACGE Vingmed Ultrasound A/SLLZ2026-10-07
00198953200438EchoPACGE Vingmed Ultrasound A/SLLZ2026-10-07
17540262200126Change Healthcare Stratus Imaging Diagnostic ViewerChange Healthcare Canada CompanyLLZ2026-10-05
00884838120433SmartCTPhilips Medical Systems Nederland B.V.JAK2026-09-28
00884838120433SmartCTPhilips Medical Systems Nederland B.V.OWB2026-09-28
00884838120433SmartCTPhilips Medical Systems Nederland B.V.LLZ2026-09-28
00190376649474CONTOUR3DALPHATEC SPINE, INC.OWB2026-09-25
00190376652313CONTOUR3DALPHATEC SPINE, INC.OWB2026-09-25
00190376652320CONTOUR3DALPHATEC SPINE, INC.OWB2026-09-25
00190376652337CONTOUR3DALPHATEC SPINE, INC.OWB2026-09-25