GE MEDICAL SYSTEMS, INC.

GE MEDICAL SYSTEMS, INC.

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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, tomography, computed, emission (KPS) (6) System, x-ray, tomography, computed (JAK) (5) Solid state x-ray imager (flat panel/digital imager) (MQB) (2) Radiological computer-assisted prioritization software for lesions (QFM) (1) System, x-ray, mobile (IZL) (1) System, x-ray, stationary (KPR) (1)

Premarket Exempt

No

Clear

AMX - 00195278003348 Catalog Number :

Device Description : AMX Navigate Designated Medical Device Assembly

Device Class : 2

Duns Number: 809785715

Premarket Exempt : No

Product Code : IZL, MQB

Prescription Use : Yes

Device Count : 1

Discovery - 00195278098603 Catalog Number :

Device Description : PET DMI Gen2 Image System Asm, No Detectors Installed, Common Weld Gantry, Manuf PET DMI Gen2 Image System Asm, No Detectors Installed, Common Weld Gantry, Manufacturing Make

Device Class : 2

Duns Number: 809785715

Premarket Exempt : No

Product Code : JAK, KPS

Prescription Use : No

Device Count : 1

Critical Care Suite - 00195278217981 Catalog Number :

Device Description : Critical Care Suite 2.0, Designated Medical Device

Device Class : 2

Duns Number: 809785715

Premarket Exempt : No

Product Code : QFM

Prescription Use : No

Device Count : 1

Omni - 00195278454218 Catalog Number :

Device Description : OMNI GANTRY 24-30 INCL. ELECTRONICS ASSY

Device Class : 2

Duns Number: 809785715

Premarket Exempt : No

Product Code : KPS, JAK

Prescription Use : No

Device Count : 1

Revolution - 00840682102490 Catalog Number :

Device Class : 2

Duns Number: 809785715

Premarket Exempt : No

Product Code : JAK

Prescription Use : Yes

Device Count : 1

Discovery - 00840682102995 Catalog Number :

Device Class : 2

Duns Number: 809785715

Premarket Exempt : No

Product Code : KPS

Prescription Use : Yes

Device Count : 1

Discovery - 00840682103053 Catalog Number :

Device Class : 2

Duns Number: 809785715

Premarket Exempt : No

Product Code : KPS

Prescription Use : Yes

Device Count : 1

Discovery - 00840682103107 Catalog Number :

Device Class : 2

Duns Number: 809785715

Premarket Exempt : No

Product Code : JAK, KPS

Prescription Use : Yes

Device Count : 1

Definium - 00840682104364 Catalog Number :

Device Class : 2

Duns Number: 809785715

Premarket Exempt : No

Product Code : KPR, MQB

Prescription Use : Yes

Device Count : 1

Discovery - 00840682108218 Catalog Number :

Device Class : 2

Duns Number: 809785715

Premarket Exempt : No

Product Code : KPS, JAK

Prescription Use : Yes

Device Count : 1

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