GENERAL ELECTRIC COMPANY

GENERAL ELECTRIC COMPANY

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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) Table, radiologic (KXJ) (3) System, nuclear magnetic resonance spectroscopic (LNI) (2) Coil, magnetic resonance, specialty (MOS) (1)

Premarket Exempt

No Yes

Clear

NA - 00195278005502 Catalog Number :

Device Description : SIGNA Pioneer System Medical Device Assembly - MDR

Device Class : 2

Duns Number: 160032025

Premarket Exempt : No

Product Code : LNH

Prescription Use : No

Device Count : 1

NA - 00195278010797 Catalog Number :

Device Description : SIGNA Premier System Medical Device Assembly, MDR

Device Class : 2

Duns Number: 160032025

Premarket Exempt : No

Product Code : MOS, LNH, LNI

Prescription Use : No

Device Count : 1

NA - 00195278023643 Catalog Number :

Device Class : 2

Duns Number: 160032025

Premarket Exempt : No

Product Code : LNH

Prescription Use : Yes

Device Count : 1

NA - 00195278122643 Catalog Number :

Device Description : 1.5T Signa HDxt Upgrade Kit Medical Device, MDR

Device Class : 2

Duns Number: 160032025

Premarket Exempt : No

Product Code : LNH

Prescription Use : No

Device Count : 1

NA - 00195278472083 Catalog Number :

Device Description : SIGNA Hero 3T Detachable Table Assembly

Device Class : 2

Duns Number: 160032025

Premarket Exempt : Yes

Product Code : KXJ

Prescription Use : No

Device Count : 1

NA - 00195278486813 Catalog Number :

Device Description : SIGNA Hero System Medical Device Assembly - MDR

Device Class : 2

Duns Number: 160032025

Premarket Exempt : No

Product Code : LNH, LNI

Prescription Use : No

Device Count : 1

NA - 00195278596628 Catalog Number :

Device Description : SIGNA Premier 3.0T Detachable Table Assembly- Wireless Gating

Device Class : 2

Duns Number: 160032025

Premarket Exempt : Yes

Product Code : KXJ

Prescription Use : No

Device Count : 1

NA - 00195278596642 Catalog Number :

Device Description : SIGNA Hero 3T Detachable Table Assembly- Wireless Gating

Device Class : 2

Duns Number: 160032025

Premarket Exempt : Yes

Product Code : KXJ

Prescription Use : No

Device Count : 1

NA - 00840682102438 Catalog Number :

Device Class : 2

Duns Number: 160032025

Premarket Exempt : No

Product Code : LNH

Prescription Use : Yes

Device Count : 1

NA - 00840682102445 Catalog Number :

Device Class : 2

Duns Number: 160032025

Premarket Exempt : No

Product Code : LNH

Prescription Use : Yes

Device Count : 1

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