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

• 07340201502273 - Leksell Stereotactic System: 2025-09-25 Post Insulated anterior
• 07340201503317 - Leksell Stereotactic System: 2025-09-25 Instrument Screwdriver, Double
• 07340201502440 - Leksell Stereotactic System: 2025-09-25 Ear Plug Holders
• 07340201502921 - Leksell Stereotactic System: 2025-09-25 Slotted Front Piece
• 07340201502914 - Leksell Stereotactic System: 2025-09-25 Post Insulated posterior long
• 07340201502488 - Leksell Stereotactic System: 2025-09-25 Curved Front Piece
• 07340201503287 - Leksell Stereotactic System: 2025-09-25 Insulated Curved Post
• 07340201502501 - Leksell Stereotactic System: 2025-09-25 MR-Adapter for GE Quadrature Head Coil