AATMA

GUDID 07340201500040

Elekta Solutions AB

Radiology 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 Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212218

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

• 07340201501528 - Leksell Vantage Stereotactic System: 2024-12-09 Leksell Vantage Key
• 07340201501504 - Leksell Vantage Stereotactic System: 2024-12-09 Leksell Vantage™ Support Arc
• 07340201502129 - Leksell Vantage Stereotactic System: 2024-12-09 LEKSELL VANTAGE CARRIER
• 07340201501511 - Leksell Vantage Stereotactic System: 2024-09-09 LEKSELL VANTAGE ARC SYSTEM
• 07340201501887 - Leksell Vantage Stereotactic System: 2024-08-22 LEKSELL VANTAGE ARC SYSTEM
• 07340201501337 - Leksell Vantage Stereotactic System: 2024-08-14 FirmFix™ 5
• 07340201501290 - Leksell Vantage Stereotactic System: 2024-08-13 FirmFix™ 3
• 07340201501313 - Leksell Vantage Stereotactic System: 2024-08-13 FirmFix™ 4