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) (6) System, planning, radiation therapy treatment (MUJ) (1) System, radiation therapy, radionuclide (IWB) (1)

Premarket Exempt

Clear

Leksell Stereotactic System Neurosurgical Instruments - 07340048311793 Catalog Number :

Device Description : INSERTION RULER

Device Class : 2

Duns Number: 507772663

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

Leksell GammaPlan - 07340048311878 Catalog Number :

Device Description : Leksell GammaPlan

Device Class : 2

Duns Number: 507772663

Premarket Exempt : No

Product Code : MUJ, IWB

Prescription Use : No

Device Count : 1

Leksell Vantage Stereotactic System - 07340048311892 Catalog Number :

Device Description : ARC CARRIER

Device Class : 2

Duns Number: 507772663

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

Leksell Vantage Stereotactic System - 07340048311946 Catalog Number :

Device Description : MRI COIL ADAPTER LOWER STOP

Device Class : 2

Duns Number: 507772663

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

Leksell Vantage Stereotactic System - 07340048311960 Catalog Number :

Device Description : MRI COIL ADAPTER UPPER STOP

Device Class : 2

Duns Number: 507772663

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

Leksell Vantage Stereotactic System - 07340048311984 Catalog Number :

Device Description : MRI COIL ADAPTER LARGE

Device Class : 2

Duns Number: 507772663

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

Leksell Vantage Stereotactic System - 07340048312004 Catalog Number :

Device Description : MRI COIL ADAPTER UNIVERSAL

Device Class : 2

Duns Number: 507772663

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

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