XiO

GUDID 00858164002114

ELEKTA, INC.

Radiation therapy software

• Primary Device ID: 00858164002114
• NIH Device Record Key: c10f6390-37fc-4520-956d-9c492bef5bd5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: XiO
• Version Model Number: XiO
• Company DUNS: 079089435
• Company Name: ELEKTA, INC.
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858164002114 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102216

FDA Product Code

• MUJ: System,Planning,Radiation Therapy Treatment

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-08-05
• Device Publish Date: 2016-09-23

Devices Manufactured by ELEKTA, INC.

• 00858164002381 - Aqua: 2023-06-30
• 00858164002367 - MOSAIQ: 2021-12-10
• 00858164002336 - MOSAIQ: 2019-11-08
• 00858164002275 - Monaco: 2019-10-25
• 00858164002237 - MOSAIQ: 2019-08-12
• 00858164002251 - MOSAIQ: 2019-08-12
• 00858164002039 - Atlas-Based Autosegmentation: 2019-08-05
• 00858164002114 - XiO: 2019-08-05
• 00858164002114 - XiO: 2019-08-05