MR-CT Roadmap 001004

GUDID 00884838059238

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.

Philips Medical Systems Nederland B.V.

Angiographic x-ray system application software Angiographic x-ray system application software Angiographic x-ray system application software Angiographic x-ray system application software Angiographic x-ray system application software Angiographic x-ray system application software Angiographic x-ray system application software Angiographic x-ray system application software Angiographic x-ray system application software Angiographic x-ray system application software Angiographic x-ray system application software Angiographic x-ray system application software Angiographic x-ray system application software Angiographic x-ray system application software Angiographic x-ray system application software Angiographic x-ray system application software Angiographic x-ray system application software Angiographic x-ray system application software
Primary Device ID00884838059238
NIH Device Record Key45d2880e-a061-4f88-892b-d871645ef68a
Commercial Distribution StatusIn Commercial Distribution
Brand NameMR-CT Roadmap
Version Model NumberMR-CT Roadmap R1
Catalog Number001004
Company DUNS413819707
Company NamePhilips Medical Systems Nederland B.V.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100884838059238 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OWBInterventional Fluoroscopic X-Ray System

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number8
Public Version Date2019-12-02
Device Publish Date2016-09-24

Devices Manufactured by Philips Medical Systems Nederland B.V.

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00884838099241 - Azurion2023-09-26 Monoplane Interventional X-Ray System. A ceiling or floor-mounted monoplane system with a 12-inch flat detector.
00884838099258 - Azurion2023-09-26 Monoplane Interventional X-Ray System. A ceiling or floor-mounted monoplane system with a 20-inch flat detector. Optionally the

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