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

Device, Patient Transfer, Powered (FRZ) (5) System, Nuclear Magnetic Resonance Imaging (LNH) (3) Stretcher, Wheeled (FPO) (2)

Premarket Exempt

No Yes

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Zephyr Patient Stretcher - B237ZTGAIX010 Catalog Number :

Device Description : Zephyr Procedural Stretcher Accessory - Stretcher Indexing. Includes removable Zephyr Procedural Stretcher Accessory - Stretcher Indexing. Includes removable side stops and floor indexing kits. (ZTG-AIX-02 also required)

Device Class : 2

Duns Number: 605813559

Premarket Exempt : Yes

Product Code : FPO

Prescription Use : Yes

Device Count : 1

Zephyr Patient Stretcher - B237ZTGAIX040 Catalog Number :

Device Description : Zephyr MR Conditional Stretcher Accessory - Stretcher Indexing. Includes removab Zephyr MR Conditional Stretcher Accessory - Stretcher Indexing. Includes removable side stops and floor indexing kits. (ZTG-AIX-02 also required)

Device Class : 2

Duns Number: 605813559

Premarket Exempt : Yes

Product Code : FPO

Prescription Use : Yes

Device Count : 1

Zephyr Patient Positioning and Transfer System - B237ZXL10 Catalog Number :

Device Description : Zephyr XL Patient Hover Board

Device Class : 2

Duns Number: 605813559

Premarket Exempt : No

Product Code : FRZ

Prescription Use : Yes

Device Count : 1

Zephyr Patient Positioning and Transfer System - B237ZXL20 Catalog Number :

Device Description : Zephyr XL Patient Hover Board for MedPhoton Imaging Tables

Device Class : 2

Duns Number: 605813559

Premarket Exempt : No

Product Code : FRZ

Prescription Use : Yes

Device Count : 1

Zephyr Patient Positioning and Transfer System - B237ZXL30 Catalog Number :

Device Description : Zephyr XL Patient Hover Board 50cm w/ Gating Plate

Device Class : 2

Duns Number: 605813559

Premarket Exempt : No

Product Code : FRZ

Prescription Use : Yes

Device Count : 1

Zephyr Patient Positioning and Transfer System - B237ZXL40 Catalog Number :

Device Description : Zephyr XL Patient Hover Board 50cm

Device Class : 2

Duns Number: 605813559

Premarket Exempt : No

Product Code : FRZ

Prescription Use : Yes

Device Count : 1

Zephyr Patient Positioning and Transfer System - B237ZXL50 Catalog Number :

Device Description : Zephyr XL Patient Hover Board LP

Device Class : 2

Duns Number: 605813559

Premarket Exempt : No

Product Code : FRZ

Prescription Use : Yes

Device Count : 1

Zephyr Patient Positioning and Transfer System - B237ZXLABP100 Catalog Number :

Device Description : Zephyr HP Accessory - Baseplate for S-Style thermoplastic masks

Device Class : 2

Duns Number: 605813559

Premarket Exempt : No

Product Code : LNH

Prescription Use : Yes

Device Count : 1

Zephyr Patient Positioning and Transfer System - B237ZXLACI100 Catalog Number :

Device Description : Zephyr IR-S Collision Indicators for Philips Ingenia MR-RT System

Device Class : 2

Duns Number: 605813559

Premarket Exempt : No

Product Code : LNH

Prescription Use : Yes

Device Count : 1

Zephyr Patient Positioning and Transfer System - B237ZXLACI110 Catalog Number :

Device Description : Zephyr IR-A 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

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