DIACOR, INC.

Address:2550 DECKER LAKE BLVD.,West Valley City,UT,84119,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

Table, Radiologic (KXJ) (10)

Premarket Exempt

No Yes

Clear

Diacor Overlay - B237ZXLTGE110 Catalog Number :

Device Description : Diacor GE GEM Cart Overlay

Device Class : 2

Duns Number: 605813559

Premarket Exempt : Yes

Product Code : KXJ

Prescription Use : Yes

Device Count : 1

Diacor Overlay - B237ZXLTGE120 Catalog Number :

Device Description : Diacor GE GEM Cart Overlay

Device Class : 2

Duns Number: 605813559

Premarket Exempt : Yes

Product Code : KXJ

Prescription Use : Yes

Device Count : 1

Diacor CT Overlay - B237ZXLTGE130 Catalog Number :

Device Description : Diacor Carbon Fiber GE CT Overlay with Stops

Device Class : 2

Duns Number: 605813559

Premarket Exempt : Yes

Product Code : KXJ

Prescription Use : Yes

Device Count : 1

Diacor Overlay - B237ZXLTGE140 Catalog Number :

Device Description : Zephyr MR FTT: Designed for GE Pioneer, Premier, and Voyager Fixed MR Couches a Zephyr MR FTT: Designed for GE Pioneer, Premier, and Voyager Fixed MR Couches and Zephyr IR Hoverboards

Device Class : 2

Duns Number: 605813559

Premarket Exempt : Yes

Product Code : KXJ

Prescription Use : Yes

Device Count : 1

Diacor Overlay - B237ZXLTGE150 Catalog Number :

Device Description : Zephyr MR FTT: Designed for GE Premier MOTUS MR Couch and Zephyr IR Hoverboard; Zephyr MR FTT: Designed for GE Premier MOTUS MR Couch and Zephyr IR Hoverboard; Single-Piece Design

Device Class : 2

Duns Number: 605813559

Premarket Exempt : Yes

Product Code : KXJ

Prescription Use : Yes

Device Count : 1

Diacor Overlay - B237ZXLTGE160 Catalog Number :

Device Description : Zephyr MR FTT: Designed for GE Premier MOTUS MR Couch and Zephyr IR Hoverboard; Zephyr MR FTT: Designed for GE Premier MOTUS MR Couch and Zephyr IR Hoverboard; Two-Piece Design

Device Class : 2

Duns Number: 605813559

Premarket Exempt : Yes

Product Code : KXJ

Prescription Use : Yes

Device Count : 1

Diacor Overlay - B237ZXLTGE170 Catalog Number :

Device Description : Zephyr MR FTT: Designed for GE MR GEM Cart and Zephyr IR-A Hoverboard

Device Class : 2

Duns Number: 605813559

Premarket Exempt : Yes

Product Code : KXJ

Prescription Use : Yes

Device Count : 1

Diacor Overlay - B237ZXLTGE200 Catalog Number :

Device Description : Zephyr MR FTT for GE MR GEM Cart

Device Class : 2

Duns Number: 605813559

Premarket Exempt : Yes

Product Code : KXJ

Prescription Use : Yes

Device Count : 1

Diacor Overlay - B237ZXLTGE300 Catalog Number :

Device Description : Zephyr MR Accessory for GE GEM Couch: Support Base for GE HNU Coil

Device Class : 2

Duns Number: 605813559

Premarket Exempt : Yes

Product Code : KXJ

Prescription Use : Yes

Device Count : 1

Diacor Overlay - B237ZXLTGE310 Catalog Number :

Device Description : Zephyr MR Accessory for GE GEM Couch: Support Base for Invivo Head Coil

Device Class : 2

Duns Number: 605813559

Premarket Exempt : Yes

Product Code : KXJ

Prescription Use : Yes

Device Count : 1

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