Philips Healthcare (Suzhou) Co., Ltd.

Address:No. 258, Zhongyuan Road,Suzhou Jiangsu,CN

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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

System, x-ray, stationary (KPR) (5) Coil, Magnetic Resonance, Specialty (MOS) (3) Solid state x-ray imager (flat panel/digital imager) (MQB) (2) System, X-Ray, Tomography, Computed (JAK) (1) System, x-ray, tomography, computed (JAK) (1)

Premarket Exempt

Clear

DuraDiagnost Compact - 00884838064737 Catalog Number : 712213

Device Description : The DuraDiagnost Compact is intended for use in generating radiographic images o

Device Class : 2

Duns Number: 421265537

Premarket Exempt : No

Product Code : KPR, MQB

Prescription Use : Yes

Device Count : 1

DuraDiagnost - 00884838064751 Catalog Number : 712214

Device Description : The DuraDiagnost is intended for use in generating radiographic images of human

Device Class : 2

Duns Number: 421265537

Premarket Exempt : No

Product Code : MQB, KPR

Prescription Use : Yes

Device Count : 1

DigitalDiagnost C50 - 00884838082366 Catalog Number : 712201

Device Description : The DigitalDiagnost C50 is intended for use in generating radiographic images of

Device Class : 2

Duns Number: 421265537

Premarket Exempt : No

Product Code : KPR

Prescription Use : Yes

Device Count : 1

Incisive CT - 00884838085015 Catalog Number :

Device Class : 2

Duns Number: 421265537

Premarket Exempt : No

Product Code : JAK

Prescription Use : Yes

Device Count : 1

DigitalDiagnost C50 - 00884838095199 Catalog Number :

Device Description : Stationary x-ray system

Device Class : 2

Duns Number: 421265537

Premarket Exempt : No

Product Code : KPR

Prescription Use : Yes

Device Count : 1

DuraDiagnost - 00884838095205 Catalog Number :

Device Description : Stationary x-ray system

Device Class : 2

Duns Number: 421265537

Premarket Exempt : No

Product Code : KPR

Prescription Use : Yes

Device Count : 1

dS TorsoCardiac 1.5T - 00884838096813 Catalog Number :

Device Description : The Device is designed to be used in conjunction with MR Scanner to produce diag

Device Class : 2

Duns Number: 421265537

Premarket Exempt : No

Product Code : MOS

Prescription Use : No

Device Count : 1

dS MSK S 1.5T - 00884838096820 Catalog Number :

Device Description : The Device is designed to be used in conjunction with MR Scanner to produce diag

Device Class : 2

Duns Number: 421265537

Premarket Exempt : No

Product Code : MOS

Prescription Use : No

Device Count : 1

dS MSK M 1.5T - 00884838096837 Catalog Number :

Device Description : The Device is designed to be used in conjunction with MR Scanner to produce diag

Device Class : 2

Duns Number: 421265537

Premarket Exempt : No

Product Code : MOS

Prescription Use : No

Device Count : 1

Incisive CT - 00884838105508 Catalog Number : 728144

Device Description : The Incisive CT is a Computed Tomography X-Ray System intended to produce cross-

Device Class : 2

Duns Number: 421265537

Premarket Exempt : No

Product Code : JAK

Prescription Use : Yes

Device Count : 1

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