Gemini360RT

GUDID 00860014221903

The Akesis Gemini360RT is a radiation therapy system based on a LINAC platform with an optional Gamma head for multimodal treatment delivery.

Akesis Inc.

Linear accelerator system

• Primary Device ID: 00860014221903
• NIH Device Record Key: 95ae0a24-85cc-4489-9df4-d71a0d0b1412
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Gemini360RT
• Version Model Number: Gemini360RT
• Company DUNS: 081307120
• Company Name: Akesis 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: false
• Serial Number: true
• 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	00860014221903 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210921

FDA Product Code

• IYE: Accelerator, Linear, Medical

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: 2025-08-25
• Device Publish Date: 2025-08-15