GE MEDICAL SYSTEMS

GE MEDICAL SYSTEMS

Address:3000 N GRANDVIEW BLVD.,Waukesha,WI,53188,US

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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

Full field digital, system, x-ray, mammographic (MUE) (5) Interventional fluoroscopic x-ray system (OWB) (3) System, x-ray, angiographic (IZI) (3) System, x-ray, fluoroscopic, image-intensified (JAA) (3) Image-intensified fluoroscopic x-ray system, mobile (OXO) (2) Digital breast tomosynthesis (OTE) (2) Restraint, protective (FMQ) (1)

Premarket Exempt

No

Clear

not applicable - 00195278009289 Catalog Number :

Device Class : 2

Duns Number: 266062561

Premarket Exempt : No

Product Code : OTE, MUE

Prescription Use : Yes

Device Count : 1

Senographe Pristina - 00195278022745 Catalog Number :

Device Description : Senographe Pristina Core System

Device Class : 2

Duns Number: 266062561

Premarket Exempt : No

Product Code : MUE

Prescription Use : No

Device Count : 1

Senographe Pristina 3D - 00195278194039 Catalog Number :

Device Description : Kit upgrade HW Single PC Infinity

Device Class : 3

Duns Number: 266062561

Premarket Exempt : No

Product Code : OTE

Prescription Use : No

Device Count : 1

Allia - 00195278215543 Catalog Number : 5855628

Device Description : Allia IGS 7 UDI

Device Class : 2

Duns Number: 266062561

Premarket Exempt : No

Product Code : JAA, IZI, OXO, OWB

Prescription Use : No

Device Count : 1

Allia - 00195278215550 Catalog Number : 5855630

Device Description : Allia IGS 7 OR UDI

Device Class : 2

Duns Number: 266062561

Premarket Exempt : No

Product Code : OWB, JAA, IZI, OXO

Prescription Use : No

Device Count : 1

Senographe Pristina - 00195278223937 Catalog Number :

Device Description : Senographe Pristina Core System

Device Class : 2

Duns Number: 266062561

Premarket Exempt : No

Product Code : MUE

Prescription Use : No

Device Count : 1

Senographe Pristina - 00195278276971 Catalog Number :

Device Description : Senographe Pristina Core System

Device Class : 2

Duns Number: 266062561

Premarket Exempt : No

Product Code : MUE

Prescription Use : No

Device Count : 1

Pristina Paddle - 00195278330390 Catalog Number :

Device Description : Sliding 19x23 flexible paddle - Labelled

Device Class : 1

Duns Number: 266062561

Premarket Exempt : No

Product Code : FMQ

Prescription Use : No

Device Count : 1

Pristina Serena - 00195278347596 Catalog Number :

Device Description : Biopsy Option

Device Class : 2

Duns Number: 266062561

Premarket Exempt : No

Product Code : MUE

Prescription Use : No

Device Count : 1

Allia - 00195278485144 Catalog Number : 5872892

Device Description : Allia IGS5 UDI

Device Class : 2

Duns Number: 266062561

Premarket Exempt : No

Product Code : OWB, JAA, IZI

Prescription Use : No

Device Count : 1

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