Elekta Instrument AB

Address:Kungstensgatan 18,Stockholm,SE

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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

Neurological stereotaxic Instrument (HAW) (8) System, planning, radiation therapy treatment (MUJ) (2) System, radiation therapy, radionuclide (IWB) (2)

Premarket Exempt

Clear

Leksell Vantage Stereotactic System - 07340048311151 Catalog Number : 1060488

Device Description : Leksell Vantage™ Support Arc

Device Class : 2

Duns Number: 507772663

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

Leksell Stereotactic System - 07340048311175 Catalog Number : 1530036

Device Description : MR-INDICATOR, RIGHT SIDE

Device Class : 2

Duns Number: 507772663

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

Leksell Stereotactic System - 07340048311182 Catalog Number : 1530038

Device Description : MR-INDICATOR, LEFT SIDE

Device Class : 2

Duns Number: 507772663

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

Leksell Stereotactic System - 07340048311199 Catalog Number : 1530039

Device Description : MR-Indicator, Anterior

Device Class : 2

Duns Number: 507772663

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

Leksell Stereotactic System - 07340048311205 Catalog Number : 1530040

Device Description : MR-INDICATOR, POSTERIOR

Device Class : 2

Duns Number: 507772663

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

Leksell Stereotactic System - 07340048311212 Catalog Number : 1530041

Device Description : MR-INDICATOR, COVER

Device Class : 2

Duns Number: 507772663

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

Leksell GammaPlan - 07340048311229 Catalog Number : 1529980

Device Description : LGP 11.1 SW MEDIA

Device Class : 2

Duns Number: 507772663

Premarket Exempt : No

Product Code : MUJ, IWB

Prescription Use : Yes

Device Count : 1

Leksell GammaPlan - 07340048311236 Catalog Number :

Device Description : LGP 11.1

Device Class : 2

Duns Number: 507772663

Premarket Exempt : No

Product Code : IWB, MUJ

Prescription Use : Yes

Device Count : 1

Leksell Vantage Stereotactic System - 07340048311281 Catalog Number : 1523231

Device Description : Leksell Vantage™ Arc Tray

Device Class : 2

Duns Number: 507772663

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

Leksell Vantage Stereotactic System - 07340048311328 Catalog Number : 1536894

Device Description : Leksell Vantage Key

Device Class : 2

Duns Number: 507772663

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

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