Philips Medical Systems DMC GmbH

Address:Roentgenstrasse 24,HAMBURG,DE

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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

Solid state x-ray imager (flat panel/digital imager) (MQB) (5) Table, radiographic, tilting (IXR) (2) Assembly, tube housing, x-ray, diagnostic (ITY) (1) System, X-Ray, Stationary (KPR) (1) System, image processing, radiological (LLZ) (1) System, Image Processing, Radiological (LLZ) (1) Generator, high-voltage, x-ray, diagnostic (IZO) (1)

Premarket Exempt

No Yes

Clear

PCR ELEVA - 00884838004047 Catalog Number : 732050

Device Description : System Image Processing, Radiological

Device Class : 2

Duns Number: 314101218

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

SkyPlate small - 00884838065215 Catalog Number :

Device Description : Solid State X-Ray Imager (Flat Panel/Digital Imager)

Device Class : 2

Duns Number: 314101218

Premarket Exempt : No

Product Code : MQB

Prescription Use : Yes

Device Count : 1

SkyPlate large - 00884838065222 Catalog Number :

Device Description : Solid State X-Ray Imager (Flat Panel/Digital Imager)

Device Class : 2

Duns Number: 314101218

Premarket Exempt : No

Product Code : MQB

Prescription Use : Yes

Device Count : 1

ProGrade - 00884838065239 Catalog Number : 712090

Device Description : Solid State X-Ray Imager (Flat Panel/Digital Imager)

Device Class : 2

Duns Number: 314101218

Premarket Exempt : No

Product Code : MQB

Prescription Use : Yes

Device Count : 1

DigitalDiagnost - 00884838065321 Catalog Number : 712031

Device Description : Stationary x-ray system

Device Class : 2

Duns Number: 314101218

Premarket Exempt : No

Product Code : MQB, KPR, LLZ

Prescription Use : Yes

Device Count : 1

XS-100 Generator - 00884838070851 Catalog Number : 9806-058-00221

Device Description : X-ray control and HV generator

Device Class : 1

Duns Number: 314101218

Premarket Exempt : Yes

Product Code : IZO

Prescription Use : No

Device Count : 1

XS-100 X-Ray Tube Assembly - 00884838070868 Catalog Number : 9806-058-00541

Device Description : diagnostic x-ray tube housing assembly

Device Class : 1

Duns Number: 314101218

Premarket Exempt : Yes

Product Code : ITY

Prescription Use : No

Device Count : 1

EasyDiagnost Eleva - 00884838074255 Catalog Number : 706050

Device Description : Table, Radiographic, Tilting

Device Class : 2

Duns Number: 314101218

Premarket Exempt : No

Product Code : IXR

Prescription Use : Yes

Device Count : 1

Height adjustable Trolley TA-M - 00884838074262 Catalog Number : 712031

Device Description : Radiologic table

Device Class : 2

Duns Number: 314101218

Premarket Exempt : Yes

Product Code : IXR

Prescription Use : Yes

Device Count : 1

Wireless Portable Detector - 00884838074279 Catalog Number : 706050

Device Description : Solid State X-Ray Imager (Flat Panel/Digital Imager)

Device Class : 2

Duns Number: 314101218

Premarket Exempt : No

Product Code : MQB

Prescription Use : Yes

Device Count : 1

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