Elekta Ltd

Address:2050 BLEURY, SUITE 200,MONTREAL Quebec,CA

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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

Accelerator, linear, medical (IYE) (3) System, radiation therapy, radionuclide (IWB) (3) System, simulation, radiation therapy (KPQ) (3)

Premarket Exempt

Clear

Clarity® - 07540180000214 Catalog Number :

Device Description : Clarity® TPUS Autoscan Position Kit

Device Class : 2

Duns Number: 248858511

Premarket Exempt : No

Product Code : IWB, IYE, KPQ

Prescription Use : Yes

Device Count : 1

Clarity® - 07540180000221 Catalog Number :

Device Description : Clarity® Software

Device Class : 2

Duns Number: 248858511

Premarket Exempt : No

Product Code : KPQ, IYE, IWB

Prescription Use : Yes

Device Count : 1

Clarity® - 07540180000238 Catalog Number :

Device Description : Clarity® Optical Tracking System

Device Class : 2

Duns Number: 248858511

Premarket Exempt : No

Product Code : KPQ, IYE, IWB

Prescription Use : Yes

Device Count : 1

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