Elekta Ltd

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) (10) System, radiation therapy, radionuclide (IWB) (10) System, simulation, radiation therapy (KPQ) (10)

Premarket Exempt

No

Clear

Clarity® - 07540180000016 Catalog Number :

Device Description : Clarity® System 310C00

Device Class : 2

Duns Number: 248858511

Premarket Exempt : No

Product Code : IWB, KPQ, IYE

Prescription Use : Yes

Device Count : 1

Clarity® - 07540180000023 Catalog Number :

Device Description : Clarity® Acquisition Station (310C00)

Device Class : 2

Duns Number: 248858511

Premarket Exempt : No

Product Code : KPQ, IYE, IWB

Prescription Use : Yes

Device Count : 1

Clarity® - 07540180000030 Catalog Number :

Device Description : Clarity® Acquisition Station (310C00) - Refurbished

Device Class : 2

Duns Number: 248858511

Premarket Exempt : No

Product Code : IWB, IYE, KPQ

Prescription Use : Yes

Device Count : 1

Clarity® - 07540180000047 Catalog Number :

Device Description : Clarity® Curved Probe (C5-2/60)

Device Class : 2

Duns Number: 248858511

Premarket Exempt : No

Product Code : IWB, KPQ, IYE

Prescription Use : Yes

Device Count : 1

Clarity® - 07540180000054 Catalog Number :

Device Description : Clarity® Curved Probe (C5-2/60) - Refurbished

Device Class : 2

Duns Number: 248858511

Premarket Exempt : No

Product Code : IWB, KPQ, IYE

Prescription Use : Yes

Device Count : 1

Clarity® - 07540180000061 Catalog Number :

Device Description : Clarity® Linear Probe (L14-5W/60)

Device Class : 2

Duns Number: 248858511

Premarket Exempt : No

Product Code : KPQ, IWB, IYE

Prescription Use : Yes

Device Count : 1

Clarity® - 07540180000078 Catalog Number :

Device Description : Clarity® Linear Probe (L14-5W/60) - Refurbished

Device Class : 2

Duns Number: 248858511

Premarket Exempt : No

Product Code : IYE, IWB, KPQ

Prescription Use : Yes

Device Count : 1

Clarity® - 07540180000085 Catalog Number :

Device Description : Clarity® TPUS Autoscan Probe (m4DC7-3/40)

Device Class : 2

Duns Number: 248858511

Premarket Exempt : No

Product Code : IWB, KPQ, IYE

Prescription Use : Yes

Device Count : 1

Clarity® - 07540180000092 Catalog Number :

Device Description : Clarity® TPUS Autoscan Probe (m4DC7-3/40) - Refurbished

Device Class : 2

Duns Number: 248858511

Premarket Exempt : No

Product Code : IWB, KPQ, IYE

Prescription Use : Yes

Device Count : 1

Clarity® - 07540180000108 Catalog Number :

Device Description : Clarity® Digitizer

Device Class : 2

Duns Number: 248858511

Premarket Exempt : No

Product Code : KPQ, IWB, IYE

Prescription Use : Yes

Device Count : 1

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