Leksell Vantage Stereotactic System 1040096

GUDID 07340201501719

Vantage™ Frame Holder extension

Elekta Solutions AB

Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system

• Primary Device ID: 07340201501719
• NIH Device Record Key: 1cae656b-0b80-4504-8874-e26892411961
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Leksell Vantage Stereotactic System
• Version Model Number: 1040096
• Catalog Number: 1040096
• Company DUNS: 353272181
• Company Name: Elekta Solutions AB
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07340201501719 [Direct Marking]
GS1	07340201501726 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190887

FDA Product Code

• HAW: Neurological Stereotaxic Instrument

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-06-28
• Device Publish Date: 2024-06-20

On-Brand Devices [Leksell Vantage Stereotactic System]

• 07340201502198: Leksell Vantage™ Head Frame
• 07340201501825: Leksell Vantage™ Head Frame
• 07340201501764: LEKSELL VANTAGE FRAME HOLDER
• 07340201501832: MRI FIDUCIAL BOX
• 07340201501535: Leksell Vantage™ Arc Tray
• 07340201501382: LEKSELL VANTAGE CT FIDUCIAL BOX
• 07340048306065: FirmFix™ Ruler
• 07340201501757: LEKSELL VANTAGE CT INTERFACE
• 07340201501719: Vantage™ Frame Holder extension
• 07340201501658: VANTAGE STARBURST 3/8
• 07340201501634: VANTAGE RADIOLUCENT STARBURST 1/2"
• 07340201501276: FirmFix™ 2
• 07340201501252: FirmFix™ 1