AQUA

GUDID 07340201500101

Elekta Solutions AB

Radiation therapy software

• Primary Device ID: 07340201500101
• NIH Device Record Key: 5eea0643-b34e-4a5c-9f2c-8cb13ef05df4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AQUA
• Version Model Number: AQUA 3.2
• Company DUNS: 353272181
• Company Name: Elekta Solutions AB
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07340201500101 [Primary]

FDA Product Code

• LHO: Instrument, Quality-Assurance, Radiologic

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: 2025-05-23
• Device Publish Date: 2025-05-15

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