DIACOR, INC.

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

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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, Radiation Therapy, Charged-Particle, Medical (LHN) (6) System, Nuclear Magnetic Resonance Imaging (LNH) (4) Table, Radiologic (KXJ) (4)

Premarket Exempt

No Yes

Clear

Zephyr Patient Positioning and Transfer System - B237ZXLASB030 Catalog Number :

Device Description : Zephyr Docking Side Stop Bar - (1): Used on 53cm Elekta iBeam Couch

Device Class : 2

Duns Number: 605813559

Premarket Exempt : No

Product Code : LHN

Prescription Use : Yes

Device Count : 1

Zephyr Patient Positioning and Transfer System - B237ZXLASB040 Catalog Number :

Device Description : Zephyr Docking Side Stop Bar - (1): Used on 50cm Non-Indexed Couch

Device Class : 2

Duns Number: 605813559

Premarket Exempt : No

Product Code : LHN

Prescription Use : Yes

Device Count : 1

Zephyr Patient Positioning and Transfer System - B237ZXLASB050 Catalog Number :

Device Description : Zephyr Docking Side Stop Bar - (1): Used on Philips Ingenia MR-SIM

Device Class : 2

Duns Number: 605813559

Premarket Exempt : No

Product Code : LHN, LNH

Prescription Use : Yes

Device Count : 1

Zephyr Patient Positioning and Transfer System - B237ZXLASB060 Catalog Number :

Device Description : Zephyr Docking Side Stop Bar - (1): Used on GE SIGNA PET/MR FTT for Zephyr Systems

Device Class : 2

Duns Number: 605813559

Premarket Exempt : No

Product Code : LHN, LNH

Prescription Use : Yes

Device Count : 1

Zephyr Patient Positioning and Transfer System - B237ZXLASR100 Catalog Number :

Device Description : GE GEM MR Cart Strain Relief for Zephyr & DORO Skull Clamp

Device Class : 2

Duns Number: 605813559

Premarket Exempt : No

Product Code : LHN, LNH

Prescription Use : Yes

Device Count : 1

Zephyr Patient Positioning and Transfer System - B237ZXLASR110 Catalog Number :

Device Description : GE GEM MR Cart Strain Relief for Zephyr & Mayfield Skull Clamp

Device Class : 2

Duns Number: 605813559

Premarket Exempt : No

Product Code : LHN, LNH

Prescription Use : Yes

Device Count : 1

Diacor Overlay - B237ZXLATB100 Catalog Number :

Device Description : Zephyr IR Bridge for GE MR GEM Cart and Zephyr IR, IR-S and IR-N Hoverboards

Device Class : 2

Duns Number: 605813559

Premarket Exempt : Yes

Product Code : KXJ

Prescription Use : Yes

Device Count : 1

Diacor Overlay - B237ZXLATB110 Catalog Number :

Device Description : Zephyr IR Bridge for GE MR GEM Cart and Maquet Magnus Imaging Table

Device Class : 2

Duns Number: 605813559

Premarket Exempt : Yes

Product Code : KXJ

Prescription Use : Yes

Device Count : 1

Diacor Overlay - B237ZXLATB130 Catalog Number :

Device Description : Zephyr IR Bridge for GE Premier MOTUS Table

Device Class : 2

Duns Number: 605813559

Premarket Exempt : Yes

Product Code : KXJ

Prescription Use : Yes

Device Count : 1

Diacor Overlay - B237ZXLATB140 Catalog Number :

Device Description : Zephyr IR Bridge for GE SIGNA PET/MR Table

Device Class : 2

Duns Number: 605813559

Premarket Exempt : Yes

Product Code : KXJ

Prescription Use : Yes

Device Count : 1

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