AATMA

GUDID 07340201500040

Elekta Solutions AB

Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software

• Primary Device ID: 07340201500040
• NIH Device Record Key: 15a8d9e9-718b-4429-9589-1a8a5390746f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AATMA
• Version Model Number: AATMA
• 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: false
• 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	07340201500040 [Primary]

FDA Product Code

• QKB: Radiological Image Processing Software For Radiation Therapy

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: 2022-03-17
• Device Publish Date: 2022-03-09

Devices Manufactured by Elekta Solutions AB

• 07340201501634 - Leksell Vantage Stereotactic System: 2024-06-28 VANTAGE RADIOLUCENT STARBURST 1/2"
• 07340201501658 - Leksell Vantage Stereotactic System: 2024-06-28 VANTAGE STARBURST 3/8
• 07340201501719 - Leksell Vantage Stereotactic System: 2024-06-28 Vantage™ Frame Holder extension
• 07340201501757 - Leksell Vantage Stereotactic System: 2024-06-28 LEKSELL VANTAGE CT INTERFACE
• 07340048306065 - Leksell Vantage Stereotactic System: 2024-06-26 FirmFix™ Ruler
• 07340201501382 - Leksell Vantage Stereotactic System: 2024-06-26 LEKSELL VANTAGE CT FIDUCIAL BOX
• 07340201501535 - Leksell Vantage Stereotactic System: 2024-06-25 Leksell Vantage™ Arc Tray
• 07340201501832 - Leksell Vantage Stereotactic System: 2024-06-25 MRI FIDUCIAL BOX