Philips Medical Systems Nederland B.V.

Address:High Tech Campus 36,Eindhoven Noord-Brabant,NL

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Interventional Fluoroscopic X-Ray System (OWB) (10) System, X-Ray, Angiographic (IZI) (7) System, X-Ray, Fluoroscopic, Image-Intensified (JAA) (2) System, Image Processing, Radiological (LLZ) (1)

Premarket Exempt

Clear

Allura Xper FD - 00884838059047 Catalog Number : 722011

Device Description : Biplane Interventional X-Ray System with floor-mounted frontal stand (10-inch fl Biplane Interventional X-Ray System with floor-mounted frontal stand (10-inch flat detector) and ceiling-mounted lateral stand ( 10-inch flat detector).

Device Class : 2

Duns Number: 413819707

Premarket Exempt : No

Product Code : OWB, IZI

Prescription Use : Yes

Device Count : 1

Allura Xper FD - 00884838059054 Catalog Number : 722012

Device Description : Monoplane Interventional X-Ray System. A ceiling or floor-mounted monoplane syst Monoplane Interventional X-Ray System. A ceiling or floor-mounted monoplane system with a 20-inch flat detector.

Device Class : 2

Duns Number: 413819707

Premarket Exempt : No

Product Code : OWB, IZI

Prescription Use : Yes

Device Count : 1

Allura Xper FD - 00884838059061 Catalog Number : 722013

Device Description : Biplane Interventional X-Ray System with floor-mounted frontal stand (20-inch fl Biplane Interventional X-Ray System with floor-mounted frontal stand (20-inch flat detector) and ceiling-mounted lateral stand (10-inch or 20-inch flat detector)

Device Class : 2

Duns Number: 413819707

Premarket Exempt : No

Product Code : OWB, IZI

Prescription Use : Yes

Device Count : 1

Allura Xper FD - 00884838059078 Catalog Number : 722022

Device Description : Monoplane Interventional X-Ray System. A ceiling-mounted monoplane system with a Monoplane Interventional X-Ray System. A ceiling-mounted monoplane system with a 10-inch flat detector and interface for an OR table

Device Class : 2

Duns Number: 413819707

Premarket Exempt : No

Product Code : OWB, IZI

Prescription Use : Yes

Device Count : 1

Allura Xper FD - 00884838059085 Catalog Number : 722023

Device Description : Monoplane Interventional X-Ray System. A ceiling-mounted monoplane system with a Monoplane Interventional X-Ray System. A ceiling-mounted monoplane system with a 20-inch flat detector and interface for an OR table

Device Class : 2

Duns Number: 413819707

Premarket Exempt : No

Product Code : OWB, IZI

Prescription Use : Yes

Device Count : 1

Allura Xper FD - 00884838059092 Catalog Number : 722024

Device Description : Biplane Interventional X-Ray System with floor-mounted frontal stand (10-inch fl Biplane Interventional X-Ray System with floor-mounted frontal stand (10-inch flat detector), ceiling-mounted lateral stand ( 10-inch flat detector) and interface for an OR table.

Device Class : 2

Duns Number: 413819707

Premarket Exempt : No

Product Code : OWB, IZI

Prescription Use : Yes

Device Count : 1

Allura Xper FD - 00884838059108 Catalog Number : 722025

Device Description : Biplane Interventional X-Ray System with floor-mounted frontal stand (20-inch fl Biplane Interventional X-Ray System with floor-mounted frontal stand (20-inch flat detector), ceiling-mounted lateral stand (10-inch or 20-inch flat detector) and interface for an OR table.

Device Class : 2

Duns Number: 413819707

Premarket Exempt : No

Product Code : OWB, IZI

Prescription Use : Yes

Device Count : 1

Allura Xper FD - 00884838059115 Catalog Number : 722058

Device Class : 2

Duns Number: 413819707

Premarket Exempt : No

Product Code : OWB, JAA

Prescription Use : Yes

Device Count : 1

Allura Xper FD - 00884838059122 Catalog Number : 722059

Device Description : Biplane Interventional X-Ray System with floor-mounted frontal stand (20-inch fl Biplane Interventional X-Ray System with floor-mounted frontal stand (20-inch flat detector), ceiling-mounted lateral stand ( 15-inch flat detector) and interface for an OR table.

Device Class : 2

Duns Number: 413819707

Premarket Exempt : No

Product Code : OWB, JAA

Prescription Use : Yes

Device Count : 1

EP navigator - 00884838059184 Catalog Number : 000071

Device Description : Software medical device, used with a Philips Interventional X-Ray System. Provid Software medical device, used with a Philips Interventional X-Ray System. Provides navigation support for cardiovascular devices for heart rhythm disorders.

Device Class : 2

Duns Number: 413819707

Premarket Exempt : No

Product Code : OWB, LLZ

Prescription Use : Yes

Device Count : 1

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