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) (7) Device, Patient Transfer, Powered (FRZ) (3)

Premarket Exempt

No Yes

Clear

Diacor Overlay - B237ZXLTMQ100 Catalog Number :

Device Description : Zephyr Flat Table Top for Maquet OR Table, includes integrated Over-Travel Prote Zephyr Flat Table Top for Maquet OR Table, includes integrated Over-Travel Protection and bridging mechanism

Device Class : 2

Duns Number: 605813559

Premarket Exempt : Yes

Product Code : KXJ

Prescription Use : Yes

Device Count : 1

Diacor Overlay - B237ZXLTMQ110 Catalog Number :

Device Description : Zephyr Articulating FTT for Maquet 1180 OR table

Device Class : 2

Duns Number: 605813559

Premarket Exempt : Yes

Product Code : KXJ

Prescription Use : Yes

Device Count : 1

Diacor Overlay - B237ZXLTOR100 Catalog Number :

Device Description : Zephyr Flat Table Top for Operating Room Table with integrated Over-Travel-Protection

Device Class : 2

Duns Number: 605813559

Premarket Exempt : Yes

Product Code : KXJ

Prescription Use : Yes

Device Count : 1

Diacor Overlay - B237ZXLTPS100 Catalog Number :

Device Description : Zephyr Flat Table Top with Integrated Over-Travel-Protection Stops for Philips Flextrak

Device Class : 2

Duns Number: 605813559

Premarket Exempt : Yes

Product Code : KXJ

Prescription Use : Yes

Device Count : 1

Diacor Overlay - B237ZXLTSM100 Catalog Number :

Device Description : Zephyr MR FTT for Siemens & Aera Systems

Device Class : 2

Duns Number: 605813559

Premarket Exempt : Yes

Product Code : KXJ

Prescription Use : Yes

Device Count : 1

Diacor Overlay - B237ZXLTSM110 Catalog Number :

Device Description : Zephyr MR Flat Table Top with Integrated Over-Travel-Protection Stops for Siemens Vida

Device Class : 2

Duns Number: 605813559

Premarket Exempt : Yes

Product Code : KXJ

Prescription Use : Yes

Device Count : 1

Diacor Overlay - B237ZXLTTF100 Catalog Number :

Device Description : Zephyr Flat Table Top for Trumpf OR Table

Device Class : 2

Duns Number: 605813559

Premarket Exempt : Yes

Product Code : KXJ

Prescription Use : Yes

Device Count : 1

Zephyr Patient Positioning and Transfer System - B237ZXLZGE100 Catalog Number :

Device Description : Zephyr XL Patient Hover Board for GE MRI Scanners

Device Class : 2

Duns Number: 605813559

Premarket Exempt : No

Product Code : FRZ

Prescription Use : Yes

Device Count : 1

Zephyr Patient Positioning and Transfer System - B237ZXLZHP100 Catalog Number :

Device Description : Zephyr HP Head and Neck Hover System

Device Class : 2

Duns Number: 605813559

Premarket Exempt : No

Product Code : FRZ

Prescription Use : Yes

Device Count : 1

Zephyr Patient Positioning and Transfer System - B237ZXLZHP200 Catalog Number :

Device Description : Zephyr HP PRO Head and Neck Hover System

Device Class : 2

Duns Number: 605813559

Premarket Exempt : No

Product Code : FRZ

Prescription Use : Yes

Device Count : 1

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