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) (7) System, Nuclear Magnetic Resonance Imaging (LNH) (5)

Premarket Exempt

No Yes

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Zephyr Patient Positioning and Transfer System - B237ZXLACI120 Catalog Number :

Device Description : Zephyr IR-A Collision Indicators for GE MOTUS MR Cart

Device Class : 2

Duns Number: 605813559

Premarket Exempt : No

Product Code : LNH

Prescription Use : Yes

Device Count : 1

Zephyr Patient Positioning and Transfer System - B237ZXLACI130 Catalog Number :

Device Description : Zephyr IR-S Collision Indicators for GE Premier Fixed Couch

Device Class : 2

Duns Number: 605813559

Premarket Exempt : No

Product Code : LNH

Prescription Use : Yes

Device Count : 1

Zephyr Patient Positioning and Transfer System - B237ZXLACI140 Catalog Number :

Device Description : Zephyr IR-S Collision Indicators for GE GEM MR Cart

Device Class : 2

Duns Number: 605813559

Premarket Exempt : No

Product Code : LNH

Prescription Use : Yes

Device Count : 1

Zephyr Patient Positioning and Transfer System - B237ZXLADK050 Catalog Number :

Device Description : Zephyr Docking Kit for Varian Exact Couch Indexing. Includes (1) side stop bar Zephyr Docking Kit for Varian Exact Couch Indexing. Includes (1) side stop bar and (1) reversible foot end docking kit.

Device Class : 2

Duns Number: 605813559

Premarket Exempt : No

Product Code : LHN

Prescription Use : Yes

Device Count : 1

Zephyr Patient Positioning and Transfer System - B237ZXLADK060 Catalog Number :

Device Description : Zephyr Docking Kit for 50cm XL on Varian. Includes (1) side stop bar and (1) rev Zephyr Docking Kit for 50cm XL on Varian. Includes (1) side stop bar and (1) reversible foot end docking kit.

Device Class : 2

Duns Number: 605813559

Premarket Exempt : No

Product Code : LHN

Prescription Use : Yes

Device Count : 1

Zephyr Patient Positioning and Transfer System - B237ZXLADK070 Catalog Number :

Device Description : Zephyr Docking Kit 53cm for Elekta iBeam Couch Indexing. Includes (1) side stop Zephyr Docking Kit 53cm for Elekta iBeam Couch Indexing. Includes (1) side stop bar and (1) reversible foot end docking kit.

Device Class : 2

Duns Number: 605813559

Premarket Exempt : No

Product Code : LHN

Prescription Use : Yes

Device Count : 1

Zephyr Patient Positioning and Transfer System - B237ZXLADK080 Catalog Number :

Device Description : Zephyr Docking Kit ___cm Trumpf Imaging Couch Includes (1) side stop bar and (1) Zephyr Docking Kit ___cm Trumpf Imaging Couch Includes (1) side stop bar and (1) reversible foot end docking kit.

Device Class : 2

Duns Number: 605813559

Premarket Exempt : No

Product Code : LHN

Prescription Use : Yes

Device Count : 1

Zephyr Patient Positioning and Transfer System - B237ZXLADK090 Catalog Number :

Device Description : Zephyr Docking Kit 50cm Hitachi Treatment Couch: Includes (1) side stop bar and Zephyr Docking Kit 50cm Hitachi Treatment Couch: Includes (1) side stop bar and (1) reversible foot end docking plate

Device Class : 2

Duns Number: 605813559

Premarket Exempt : No

Product Code : LHN

Prescription Use : Yes

Device Count : 1

Zephyr Patient Positioning and Transfer System - B237ZXLADK100 Catalog Number :

Device Description : Zephyr Docking Kit 50cm for GE PET/MR Flat Table Top (FTT)

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 - B237ZXLADK500 Catalog Number :

Device Description : Zephyr Docking Kit for Varian Exact Couch Indexing. Includes (1) side stop bar a Zephyr Docking Kit for Varian Exact Couch Indexing. Includes (1) side stop bar and (1) reversible foot end docking kit for MR couch

Device Class : 2

Duns Number: 605813559

Premarket Exempt : No

Product Code : LHN, LNH

Prescription Use : Yes

Device Count : 1

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