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

Monitor, Patient Position, Light-Beam (IWE) (5) Table, Radiologic (KXJ) (4) Device, Patient Transfer, Powered (FRZ) (1)

Premarket Exempt

No Yes

Clear

Centralite Patient Positioning Laser - B237MLC5PC0 Catalog Number :

Device Description : Five Moving Laser Controller w/ TPS Connectivity

Device Class : 1

Duns Number: 605813559

Premarket Exempt : Yes

Product Code : IWE

Prescription Use : Yes

Device Count : 1

Centralite Patient Positioning Laser - B237MLK10 Catalog Number :

Device Description : CML Wall Mount Kit

Device Class : 1

Duns Number: 605813559

Premarket Exempt : Yes

Product Code : IWE

Prescription Use : Yes

Device Count : 1

Centralite Patient Positioning Laser - B237MLK30 Catalog Number :

Device Description : CML Wall Mount Kit

Device Class : 1

Duns Number: 605813559

Premarket Exempt : Yes

Product Code : IWE

Prescription Use : Yes

Device Count : 1

Centralite Patient Positioning Laser - B237MLK40 Catalog Number :

Device Description : CML Wall Mount Kit

Device Class : 1

Duns Number: 605813559

Premarket Exempt : Yes

Product Code : IWE

Prescription Use : Yes

Device Count : 1

Centralite Patient Positioning Laser - B237MLT20 Catalog Number :

Device Description : Moving Laser Handheld Pendant with holster and cable

Device Class : 1

Duns Number: 605813559

Premarket Exempt : Yes

Product Code : IWE

Prescription Use : Yes

Device Count : 1

Diacor CT Overlay - B237OGS40 Catalog Number :

Device Description : Diacor Carbon Fiber CT Overlay for GE Tables: Standard

Device Class : 2

Duns Number: 605813559

Premarket Exempt : Yes

Product Code : KXJ

Prescription Use : Yes

Device Count : 1

Diacor Overlay - B237OGS60 Catalog Number :

Device Description : Diacor Kevlar GE PET/MR Overlay

Device Class : 2

Duns Number: 605813559

Premarket Exempt : Yes

Product Code : KXJ

Prescription Use : Yes

Device Count : 1

Diacor Overlay - B237OGT10 Catalog Number :

Device Description : Radiation Oncology Flat Table Top (FTT) for GE Tandem D670

Device Class : 2

Duns Number: 605813559

Premarket Exempt : Yes

Product Code : KXJ

Prescription Use : Yes

Device Count : 1

Diacor CT Overlay - B237OTS10 Catalog Number :

Device Description : Diacor Carbon Fiber CT Overlay for Toshiba Tables: Standard

Device Class : 2

Duns Number: 605813559

Premarket Exempt : Yes

Product Code : KXJ

Prescription Use : Yes

Device Count : 1

Zephyr Patient Positioning and Transfer System - B237ZBL11000 Catalog Number :

Device Description : Zephyr Blower Kit for 110-120v

Device Class : 2

Duns Number: 605813559

Premarket Exempt : No

Product Code : FRZ

Prescription Use : Yes

Device Count : 1

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