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) (10)

Premarket Exempt

Clear

Leksell Stereotactic System - 07340048300933 Catalog Number :

Device Description : MR-ADAPTER SIEMENS CONICAL HEADCOIL

Device Class : 2

Duns Number: 507772663

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

Leksell Stereotactic System - 07340048300940 Catalog Number :

Device Description : MR-ADAPTER SIEMENS CP HEAD ARRAY

Device Class : 2

Duns Number: 507772663

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

Leksell Stereotactic System - 07340048300957 Catalog Number :

Device Description : MR-ADAPTER TOSHIBA MRT 200/FX

Device Class : 2

Duns Number: 507772663

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

Leksell Stereotactic System - 07340048300964 Catalog Number :

Device Description : MR-ADAPTER RESONEX

Device Class : 2

Duns Number: 507772663

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

Leksell Stereotactic System - 07340048300995 Catalog Number :

Device Description : CT-TABLE FIXATION, GE PACE

Device Class : 2

Duns Number: 507772663

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

Leksell Stereotactic System - 07340048301008 Catalog Number :

Device Description : CT-TABLE FIXATION, PHILIPS TOMO

Device Class : 2

Duns Number: 507772663

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

Leksell Stereotactic System - 07340048301022 Catalog Number :

Device Description : CT TABLE FIX TOSHIBA

Device Class : 2

Duns Number: 507772663

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

Leksell Stereotactic System - 07340048301039 Catalog Number :

Device Description : CT TABLE FIXATION FOR PHILIPS NON-METAL

Device Class : 2

Duns Number: 507772663

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

Leksell Stereotactic System - 07340048301046 Catalog Number :

Device Description : X-RAY INDICATOR WITH MARKERS

Device Class : 2

Duns Number: 507772663

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

Leksell Stereotactic System - 07340048301077 Catalog Number :

Device Description : TABLE FIX X-RAY, FLAT 210 MM

Device Class : 2

Duns Number: 507772663

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

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