Philips Medical Systems Nederland B.V.

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

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Filters

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) (8) System, X-Ray, Fluoroscopic, Image-Intensified (JAA) (8) System, nuclear magnetic resonance imaging (LNH) (2) System, nuclear magnetic resonance spectroscopic (LNI) (2) Image-Intensified Fluoroscopic X-Ray System, Mobile (OXO) (1)

Premarket Exempt

Clear

Ingenia - 00884838009813 Catalog Number : 781377

Device Description : MRDD Equipment

Device Class : 2

Duns Number: 413819707

Premarket Exempt : No

Product Code : LNI, LNH

Prescription Use : Yes

Device Count : 1

Ingenia - 00884838009820 Catalog Number : 781396

Device Description : MRDD Equipment

Device Class : 2

Duns Number: 413819707

Premarket Exempt : No

Product Code : LNH, LNI

Prescription Use : Yes

Device Count : 1

Veradius - 00884838044302 Catalog Number : 718131

Device Description : Mobile, diagnostic X-ray imaging and viewing system with Flat Detector. Used for Mobile, diagnostic X-ray imaging and viewing system with Flat Detector. Used for radiological guidance and visualization during diagnostic, interventional, and surgical procedures.

Device Class : 2

Duns Number: 413819707

Premarket Exempt : No

Product Code : OWB, OXO, JAA

Prescription Use : Yes

Device Count : 1

Allura Xper FD - 00884838054189 Catalog Number : 722026

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 10-inch flat detector.

Device Class : 2

Duns Number: 413819707

Premarket Exempt : No

Product Code : OWB, JAA

Prescription Use : Yes

Device Count : 1

Allura Xper FD - 00884838054196 Catalog Number : 722027

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, JAA

Prescription Use : Yes

Device Count : 1

Allura Xper FD - 00884838054202 Catalog Number : 722028

Device Class : 2

Duns Number: 413819707

Premarket Exempt : No

Product Code : OWB, JAA

Prescription Use : Yes

Device Count : 1

Allura Xper FD - 00884838054219 Catalog Number : 722029

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 flat detector).

Device Class : 2

Duns Number: 413819707

Premarket Exempt : No

Product Code : OWB, JAA

Prescription Use : Yes

Device Count : 1

Allura Xper FD - 00884838054226 Catalog Number : 722038

Device Class : 2

Duns Number: 413819707

Premarket Exempt : No

Product Code : OWB, JAA

Prescription Use : Yes

Device Count : 1

Allura Xper FD - 00884838054233 Catalog Number : 722033

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, JAA

Prescription Use : Yes

Device Count : 1

Allura Xper FD - 00884838054240 Catalog Number : 722035

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, JAA

Prescription Use : Yes

Device Count : 1

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