Azurion 722067

GUDID 00884838085350

Biplane Interventional X-Ray System with floor-mounted frontal stand (12-inch flat detector), ceiling-mounted lateral stand (12-inch flat detector) and optional interface for an OR table.

Philips Medical Systems Nederland B.V.

Stationary angiographic x-ray system, digital Stationary angiographic x-ray system, digital Stationary angiographic x-ray system, digital Stationary angiographic x-ray system, digital Stationary angiographic x-ray system, digital Stationary angiographic x-ray system, digital Stationary angiographic x-ray system, digital Stationary angiographic x-ray system, digital Stationary angiographic x-ray system, digital Stationary angiographic x-ray system, digital Stationary angiographic x-ray system, digital Stationary angiographic x-ray system, digital Stationary angiographic x-ray system, digital Stationary angiographic x-ray system, digital Stationary angiographic x-ray system, digital Stationary angiographic x-ray system, digital Stationary angiographic x-ray system, digital Stationary angiographic x-ray system, digital
Primary Device ID00884838085350
NIH Device Record Key2897cbc1-242b-4720-a046-84d0856f501a
Commercial Distribution StatusIn Commercial Distribution
Brand NameAzurion
Version Model NumberAzurion 7 B12
Catalog Number722067
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 Batchfalse
Serial Numbertrue
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
GS100884838085350 [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 Number5
Public Version Date2019-09-20
Device Publish Date2017-12-04

On-Brand Devices [Azurion]

00884838085367Biplane Interventional X-Ray System with floor-mounted frontal stand (20-inch flat detector), ce
00884838085350Biplane Interventional X-Ray System with floor-mounted frontal stand (12-inch flat detector), ce
00884838085282Monoplane Interventional X-Ray System. A floor-mounted monoplane system with a 15-inch flat det
00884838085275Monoplane Interventional X-Ray System. A floor-mounted monoplane system with a 12-inch flat det
00884838085268Monoplane Interventional X-Ray System. A ceiling or floor-mounted monoplane system with a 20-inc
00884838085251Monoplane Interventional X-Ray System. A ceiling or floor-mounted monoplane system with a 12-inc
00884838116740Monoplane Interventional X-Ray System. A ceiling monoplane system with a 12-inch flat detector.
00884838116733Monoplane Interventional X-Ray System. A floor-mounted monoplane system with a 15-inch flat dete
00884838116726Monoplane Interventional X-Ray System. A floor-mounted monoplane system with a 12-inch flat dete
00884838116801Biplane Interventional X-Ray System with floor-mounted frontal stand (20-inch flat detector), ce
00884838116788Biplane Interventional X-Ray System with floor-mounted frontal stand (12-inch flat detector), ce
00884838116771Monoplane Interventional X-Ray System. A ceiling or floor-mounted monoplane system with a 20-inc
00884838116764Monoplane Interventional X-Ray System. A ceiling or floor-mounted monoplane system with a 12-inc
00884838116757Monoplane Interventional X-Ray System. A ceiling or floor-mounted monoplane system with a 20-inc
00884838099272Biplane Interventional X-Ray System with floor-mounted frontal stand (20-inch flat detector), ce
00884838099265Biplane Interventional X-Ray System with floor-mounted frontal stand (12-inch flat detector), ce
00884838099258Monoplane Interventional X-Ray System. A ceiling or floor-mounted monoplane system with a 20-inc
00884838099241Monoplane Interventional X-Ray System. A ceiling or floor-mounted monoplane system with a 12-inc
00884838099234Monoplane Interventional X-Ray System. A ceiling or floor-mounted monoplane system with a 20-inc
00884838099227Monoplane Interventional X-Ray System. A ceiling or floor-mounted monoplane system with a 12-inc
00884838099210Monoplane Interventional X-Ray System. A floor-mounted monoplane system with a 15-inch flat det
00884838099203Monoplane Interventional X-Ray System. A floor-mounted monoplane system with a 12-inch flat det

Trademark Results [Azurion]

Mark Image

Registration | Serial
Company
Trademark
Application Date
AZURION
AZURION
79162838 5051661 Live/Registered
KONINKLIJKE PHILIPS N.V.
2015-03-04

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.