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) (9) System, Nuclear Magnetic Resonance Imaging (LNH) (1) Table, Radiologic (KXJ) (1)

Premarket Exempt

No Yes

Clear

Zephyr Patient Positioning and Transfer System - B237ZXLADK510 Catalog Number :

Device Description : Zephyr Docking Kit for Philips Ingenia MR-SIM Includes (2) side stop bar and (1) Zephyr Docking Kit for Philips Ingenia MR-SIM Includes (2) side stop bar and (1) foot end stop

Device Class : 2

Duns Number: 605813559

Premarket Exempt : No

Product Code : LHN, LNH

Prescription Use : Yes

Device Count : 1

Diacor Overlay - B237ZXLAHC010 Catalog Number :

Device Description : Zephyr MR Head Coil Support for Siemens Skyra & Aera Systems

Device Class : 2

Duns Number: 605813559

Premarket Exempt : Yes

Product Code : KXJ

Prescription Use : Yes

Device Count : 1

Zephyr Patient Positioning and Transfer System - B237ZXLAOT100 Catalog Number :

Device Description : OTP (Over-travel protection) solution kit for Philips AD7NT Imaging Table

Device Class : 2

Duns Number: 605813559

Premarket Exempt : No

Product Code : LHN

Prescription Use : Yes

Device Count : 1

Zephyr Patient Positioning and Transfer System - B237ZXLAOT110 Catalog Number :

Device Description : OTP (Over-travel protection) solution kit for Maquet Magnus 1180 Imaging Table

Device Class : 2

Duns Number: 605813559

Premarket Exempt : No

Product Code : LHN

Prescription Use : Yes

Device Count : 1

Zephyr Patient Positioning and Transfer System - B237ZXLAOT120 Catalog Number :

Device Description : OTP (Over-travel protection) solution kit for GE Omega or IQ Tilt Tables

Device Class : 2

Duns Number: 605813559

Premarket Exempt : No

Product Code : LHN

Prescription Use : Yes

Device Count : 1

Zephyr Patient Positioning and Transfer System - B237ZXLAOT130 Catalog Number :

Device Description : OTP (Over-travel protection) solution kit for Trumpf Hybrid Carbon Fiber Table Top

Device Class : 2

Duns Number: 605813559

Premarket Exempt : No

Product Code : LHN

Prescription Use : Yes

Device Count : 1

Zephyr Patient Positioning and Transfer System - B237ZXLAOT140 Catalog Number :

Device Description : OTP (Over-travel protection) solution kit for Canon Angio Imaging Tables

Device Class : 2

Duns Number: 605813559

Premarket Exempt : No

Product Code : LHN

Prescription Use : Yes

Device Count : 1

Zephyr Patient Positioning and Transfer System - B237ZXLAOT150 Catalog Number :

Device Description : OTP (Over-travel protection) solution kit for Hillrom/Trumpf Carbon Floatline

Device Class : 2

Duns Number: 605813559

Premarket Exempt : No

Product Code : LHN

Prescription Use : Yes

Device Count : 1

Zephyr Patient Positioning and Transfer System - B237ZXLASB010 Catalog Number :

Device Description : Zephyr Docking Side Stop Bar - (1): Used on 53cm Varian 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 - B237ZXLASB020 Catalog Number :

Device Description : Zephyr Docking Side Stop Bar for 50cm XL - (1): Used on 53cm Varian Couch

Device Class : 2

Duns Number: 605813559

Premarket Exempt : No

Product Code : LHN

Prescription Use : Yes

Device Count : 1

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