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) (6) Generator, high-voltage, x-ray, diagnostic (IZO) (4)

Premarket Exempt

No Yes

Clear

MRM 0410 ROT-GS 2502 - 00884838076075 Catalog Number : 9890-000-63272

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

SRM 2250 ROT-GS 504 - 00884838076099 Catalog Number : 9890-000-63842

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

SRM 0612 ROT 500 - 00884838076105 Catalog Number : 9890-000-63901

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

Velara CVFD - 00884838076129 Catalog Number : 9890-000-65077

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

Certeray iX - 00884838076136 Catalog Number : 9890-000-65306

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

Velara R/F 2T - 00884838076143 Catalog Number : 9890-000-70297

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

Velara GCF 2T - 00884838076150 Catalog Number : 9890-000-70307

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

SRM 0612 ROT 504 - 00884838076167 Catalog Number : 9890-000-85002

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

MRC 200 0310 ROT-GS 1004 - 00884838076174 Catalog Number : 9890-000-85092

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

MRC 200 0407 ROT-GS 1004 - 00884838076181 Catalog Number : 9890-000-85103

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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