Ethos Radiotherapy System

GUDID 00857235006099

VARIAN MEDICAL SYSTEMS, INC.

Linear accelerator system

• Primary Device ID: 00857235006099
• NIH Device Record Key: 837700ac-a9ad-47b7-801c-200619625d9d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ethos Radiotherapy System
• Version Model Number: 4.0
• Company DUNS: 009120817
• Company Name: VARIAN MEDICAL SYSTEMS, 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: true
• 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	00857235006099 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222941

FDA Product Code

• IYE: Accelerator, linear, medical

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2026-01-13
• Device Publish Date: 2023-01-24

Devices Manufactured by VARIAN MEDICAL SYSTEMS, INC.

• 00899475002110 - High-Definition 120 Multileaf Collimator: 2026-01-14
• 00857235006075 - Halcyon: 2026-01-13
• 00857235006099 - Ethos Radiotherapy System: 2026-01-13
• 00857235006099 - Ethos Radiotherapy System: 2026-01-13
• 00858086006931 - IDENTIFY: 2025-12-30
• 00810563022629 - Guiding tube 60 degrees ring for central needle: 2025-12-03
• 00816389028937 - Guided Aarhus Applicator Set: 2025-12-03
• 00816389028944 - Guided Aarhus vaginal template 60 degrees,ø 28 mm: 2025-12-03
• 00816389028951 - Guided Aarhus vaginal template 60 degrees, ø 32 mm: 2025-12-03