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

System, radiation therapy, radionuclide (IWB) (6) Neurological Stereotaxic Instrument (HAW) (2) Neurological stereotaxic Instrument (HAW) (2)

Premarket Exempt

Clear

Leksell Stereotactic System - 07340048311564 Catalog Number : 50152-04

Device Description : STERILIZING TRAY FOR MULTIPURPOSE ARC

Device Class : 2

Duns Number: 507772663

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

Leksell Gamma Knife Icon - 07340048311588 Catalog Number : 1030758

Device Description : PATIENT MARKERS (10 PCS)

Device Class :

Duns Number: 507772663

Premarket Exempt : No

Product Code : IWB

Prescription Use : Yes

Device Count : 10

Leksell Vantage Stereotactic System - 07340048311595 Catalog Number : 1072931

Device Description : VANTAGE RADIOLUCENT STARBURST 1/2"

Device Class : 2

Duns Number: 507772663

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

Leksell Vantage Stereotactic System - 07340048311618 Catalog Number : 1072929

Device Description : VANTAGE STARBURST 3/8

Device Class : 2

Duns Number: 507772663

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

Leksell Stereotactic System - 07340048311632 Catalog Number :

Device Description : FRAME FIXATION STERILIZING TRAY

Device Class : 2

Duns Number: 507772663

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

Leksell Gamma Knife Perfexion/Icon - 07340048311700 Catalog Number :

Device Description : FILM HOLDER VANTAGE LGK

Device Class : 2

Duns Number: 507772663

Premarket Exempt : No

Product Code : IWB

Prescription Use : Yes

Device Count : 1

Leksell Gamma Knife Perfexion/Icon - 07340048311731 Catalog Number :

Device Description : Dosimetry Phantom Vantage Base

Device Class : 2

Duns Number: 507772663

Premarket Exempt : No

Product Code : IWB

Prescription Use : Yes

Device Count : 1

Leksell Gamma Knife Perfexion/Icon - 07340048311755 Catalog Number :

Device Description : QA TOOL VANTAGE LGK

Device Class : 2

Duns Number: 507772663

Premarket Exempt : No

Product Code : IWB

Prescription Use : Yes

Device Count : 1

Leksell Gamma Knife Perfexion/Icon - 07340048311762 Catalog Number :

Device Description : Dosimetry Phantom Vantage LGK

Device Class : 2

Duns Number: 507772663

Premarket Exempt : No

Product Code : IWB

Prescription Use : Yes

Device Count : 1

Leksell Gamma Knife Icon - 07340048311786 Catalog Number :

Device Description : LEKSELL VANTAGE ADAPTER LGK

Device Class : 2

Duns Number: 507772663

Premarket Exempt : No

Product Code : IWB

Prescription Use : Yes

Device Count : 1

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