XiO

GUDID 00858164002114

ELEKTA, INC.

Radiation therapy software Radiation therapy software Radiation therapy software Radiation therapy software Radiation therapy software Radiation therapy software Radiation therapy software Radiation therapy software Radiation therapy software Radiation therapy software 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