GE Medical Systems (Tianjin) Co., Ltd.

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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, nuclear magnetic resonance imaging (LNH) (7) Coil, magnetic resonance, specialty (MOS) (3) System, nuclear magnetic resonance spectroscopic (LNI) (2)

Premarket Exempt

No Yes

Clear

NA - 00840682118576 Catalog Number :

Device Description : 1.5T 4CH LARGE FLEX COIL

Device Class : 2

Duns Number: 421356265

Premarket Exempt : No

Product Code : MOS

Prescription Use : No

Device Count : 1

NA - 00840682118606 Catalog Number :

Device Description : 1.5T 4CH SMALL FLEX COIL

Device Class : 2

Duns Number: 421356265

Premarket Exempt : No

Product Code : MOS

Prescription Use : No

Device Count : 1

NA - 00840682118934 Catalog Number :

Device Description : HEAD NECK ARRAY, 1.5T EXPRESS COIL

Device Class : 2

Duns Number: 421356265

Premarket Exempt : No

Product Code : LNI, LNH

Prescription Use : No

Device Count : 1

NA - 00840682118958 Catalog Number :

Device Description : 1.5T 16 CHANNEL,HEAD NECK ARRAY

Device Class : 2

Duns Number: 421356265

Premarket Exempt : No

Product Code : LNH

Prescription Use : No

Device Count : 1

NA - 00840682118989 Catalog Number :

Device Description : 1.5T Anterior Array,Express Coil

Device Class : 2

Duns Number: 421356265

Premarket Exempt : No

Product Code : LNI, LNH

Prescription Use : No

Device Count : 1

NA - 00840682118996 Catalog Number :

Device Description : 1.5T Express Coil - 9E Anterior Array

Device Class : 2

Duns Number: 421356265

Premarket Exempt : No

Product Code : LNH

Prescription Use : No

Device Count : 1

NA - 00840682119214 Catalog Number :

Device Description : GE 8ch Foot Ankle Coil Assembly

Device Class : 2

Duns Number: 421356265

Premarket Exempt : No

Product Code : MOS

Prescription Use : No

Device Count : 1

NA - 00840682146104 Catalog Number :

Device Class : 2

Duns Number: 421356265

Premarket Exempt : No

Product Code : LNH

Prescription Use : Yes

Device Count : 1

NA - 00840682146302 Catalog Number :

Device Description : SIGNA Prime System Medical Device

Device Class : 2

Duns Number: 421356265

Premarket Exempt : No

Product Code : LNH

Prescription Use : No

Device Count : 1

NA - 00840682146814 Catalog Number :

Device Class : 2

Duns Number: 421356265

Premarket Exempt : No

Product Code : LNH

Prescription Use : Yes

Device Count : 1

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