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

Assembly, tube housing, x-ray, diagnostic (ITY) (5) Generator, high-voltage, x-ray, diagnostic (IZO) (3) System, X-Ray, Fluoroscopic, Image-Intensified (JAA) (1) System, X-Ray, Stationary (KPR) (1)

Premarket Exempt

No Yes

Clear

XS-100 Generator - 00884838103788 Catalog Number : 9806-058-00224

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 Generator - 00884838103795 Catalog Number : 3000-049-72101

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

Philips Radiology Smart Assistant - 00884838104013 Catalog Number : 30000581513X

Device Class : 2

Duns Number: 314101218

Premarket Exempt : No

Product Code : KPR, JAA

Prescription Use : Yes

Device Count : 1

vMRC Performance - 00884838107168 Catalog Number : 9890-000-87381

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

CT8000 - 00884838107229 Catalog Number : 9806-058-01431

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

XS-100 Generator - 00884838107236 Catalog Number : 9806-058-00611

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 - 00884838107243 Catalog Number : 9806-058-01341

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

XS-100 X-Ray Tube Assembly - 00884838108158 Catalog Number : 9806-058-01351

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

CT8000 - 00884838108189 Catalog Number : 9806-058-01441

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

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