Leksell Vantage Stereotactic System 1051800

GUDID 07340048305167

Leksell Vantage™ Head Frame

Elekta Instrument AB

Neurological stereotactic surgery system
Primary Device ID07340048305167
NIH Device Record Keyb3d9eca9-3d9d-4003-92cb-07115389e1eb
Commercial Distribution StatusIn Commercial Distribution
Brand NameLeksell Vantage Stereotactic System
Version Model Number1051800
Catalog Number1051800
Company DUNS507772663
Company NameElekta Instrument AB
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(855)693-5358
Emailinfo.america@elekta.com
Phone+1(855)693-5358
Emailinfo.america@elekta.com
Phone+1(855)693-5358
Emailinfo.america@elekta.com
Phone+1(855)693-5358
Emailinfo.america@elekta.com
Phone+1(855)693-5358
Emailinfo.america@elekta.com
Phone+1(855)693-5358
Emailinfo.america@elekta.com
Phone+1(855)693-5358
Emailinfo.america@elekta.com
Phone+1(855)693-5358
Emailinfo.america@elekta.com
Phone+1(855)693-5358
Emailinfo.america@elekta.com
Phone+1(855)693-5358
Emailinfo.america@elekta.com
Phone+1(855)693-5358
Emailinfo.america@elekta.com

Device Identifiers

Device Issuing AgencyDevice ID
GS107340048305167 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HAWNeurological stereotaxic Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number2
Public Version Date2018-07-06
Device Publish Date2018-03-10

On-Brand Devices [Leksell Vantage Stereotactic System]

07340048311335Leksell Vantage Key
07340048311281Leksell Vantage™ Arc Tray
07340048311151Leksell Vantage™ Support Arc
07340048305167Leksell Vantage™ Head Frame
07340048304887ARC CARRIER
07340048304870GUIDE SLIDE
07340048304863STOP SLIDE
07340048304856ARC COMPLETE
07340048304849SUPPORT ARC COMPLETE
07340048304832ARC SUPPORT LEFT
07340048304825ARC SUPPORT RIGHT
07340048304818ARC SLIDE LEFT
07340048304801ARC SLIDE RIGHT
07340048304795ARC Y SCALE RIGHT
07340048304788ARC Y SCALE LEFT
07340048304757MRI PLATE ASSEMBLY RIGHT
07340048304726MRI PLATE ASSEMBLY LEFT
07340048304719MRI FIDUCIAL ARCH POSTERIOR
07340048304702MRI FIDUCIAL ARCH ANTERIOR
07340048304696CROSS HAIR TARGET RING
07340048304689CROSS HAIR TARGET CROSS
07340048304672STARBURST RADIOLUSCENT ADAPTER
07340048304665STARBURST ADAPTER
07340048304658RADIOLUSCENT ADAPTER
07340048304412Leksell Vantage Head Frame Positioning Band
07340048304405LEKSELL VANTAGE CROSS-HAIRS
07340048304399LEKSELL VANTAGE ARC SYSTEM
07340048304382LEKSELL VANTAGE OR ADAPTER
07340048304375MRI FIDUCIAL BOX
07340048304368MRI COIL ADAPTER UPPER STOP
07340048304351MRI COIL ADAPTER UNIVERSAL
07340048304344MRI COIL ADAPTER LOWER STOP
07340048304337MRI COIL ADAPTER LARGE
07340048311342FirmFix™ Ruler
07340048304290FirmFix™ 5
07340048304276FirmFix™ 4
07340048304252FirmFix™ 3
07340048304238FirmFix™ 2
07340048304214FirmFix™ 1
07340048304207Leksell Vantage™ Head Frame
07340048311625VANTAGE STARBURST 3/8
07340048311601VANTAGE RADIOLUCENT STARBURST 1/2"
07340048311472LEKSELL VANTAGE CT INTERFACE
07340048311458Vantage™ Frame Holder extension
07340048311434LEKSELL VANTAGE CT FIDUCIAL BOX
07340048311373LEKSELL VANTAGE FRAME HOLDER
07340048311991MRI COIL ADAPTER LARGE
07340048311977MRI COIL ADAPTER UPPER STOP
07340048311953MRI COIL ADAPTER LOWER STOP
07340048312011MRI COIL ADAPTER UNIVERSAL
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.