Siemens Shenzhen Magnetic Resonance Ltd.

Address:SIEMEN MRI CENTER, Gaoxin C.Ave.,2nd,SHENZHEN Guangdong,CN

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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, nuclear magnetic resonance imaging (LNH) (10) Coil, magnetic resonance, specialty (MOS) (9) System, nuclear magnetic resonance spectroscopic (LNI) (9) Tomographic imager combining emission computed tomography with nuclear magnetic resonance (OUO) (2)

Premarket Exempt

Clear

3T Shoulder Coil Set - 04056869015088 Catalog Number :

Device Description : Contains Medical Devices Mat. 10500087 (GTIN:04056869015026) and Mat.10500088 (G Contains Medical Devices Mat. 10500087 (GTIN:04056869015026) and Mat.10500088 (GTIN:04056869015033)

Device Class : 2

Duns Number: 544891302

Premarket Exempt : No

Product Code : LNI, LNH, MOS

Prescription Use : No

Device Count : 1

Hand/Wrist 16 3T coil set - 04056869015095 Catalog Number :

Device Description : Contains Medical Device Mat. 10499849 (GTIN:04056869014982)

Device Class : 2

Duns Number: 544891302

Premarket Exempt : No

Product Code : LNI, MOS, LNH

Prescription Use : No

Device Count : 1

098 3T Foot Ankle Coil Set - 04056869015101 Catalog Number :

Device Description : Contains Medical Device Mat. 10500090 (GTIN:04056869015040)

Device Class : 2

Duns Number: 544891302

Premarket Exempt : No

Product Code : LNH, MOS, LNI

Prescription Use : No

Device Count : 1

Monet 3T body 6 - 04056869015293 Catalog Number :

Device Description : MRI Coil

Device Class : 2

Duns Number: 544891302

Premarket Exempt : No

Product Code : LNI, LNH, MOS

Prescription Use : No

Device Count : 1

Body 6 kit 030 - 04056869015309 Catalog Number :

Device Description : Contains Medical Device Mat. 10654289 (GTIN:04056869015293)

Device Class : 2

Duns Number: 544891302

Premarket Exempt : No

Product Code : LNI, MOS, LNH

Prescription Use : No

Device Count : 1

head/neck 16 set - 04056869015316 Catalog Number :

Device Description : Contains Medical Device Mat. 10654575 (GTIN:04056869015323)

Device Class : 2

Duns Number: 544891302

Premarket Exempt : No

Product Code : LNH, MOS, LNI

Prescription Use : No

Device Count : 1

Head/Neck 16 - 04056869015323 Catalog Number :

Device Description : MRI Coil

Device Class : 2

Duns Number: 544891302

Premarket Exempt : No

Product Code : LNI, MOS, LNH

Prescription Use : No

Device Count : 1

special purpose coil 4 - 04056869015330 Catalog Number :

Device Description : MRI Coil

Device Class : 2

Duns Number: 544891302

Premarket Exempt : No

Product Code : MOS, OUO, LNH, LNI

Prescription Use : No

Device Count : 1

special purpose coil 4 set - 04056869015347 Catalog Number :

Device Description : Contains Medical Device Mat. 10654891 (GTIN:04056869015330)

Device Class : 2

Duns Number: 544891302

Premarket Exempt : No

Product Code : LNH, LNI, MOS, OUO

Prescription Use : No

Device Count : 1

Extremity coil 18 - 04056869015354 Catalog Number :

Device Description : MRI Coil

Device Class : 2

Duns Number: 544891302

Premarket Exempt : No

Product Code : LNH

Prescription Use : No

Device Count : 1

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