Ethos™ Treatment Management

GUDID 00856100006271

VARIAN MEDICAL SYSTEMS, INC.

Radiation therapy software

• Primary Device ID: 00856100006271
• NIH Device Record Key: 2850eef5-322e-42fa-9ff5-7e1ce71373ee
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ethos™ Treatment Management
• Version Model Number: 2.1
• 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: true
• Serial Number: false
• 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	00856100006271 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212294

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: 2021-09-13
• Device Publish Date: 2021-09-03

Devices Manufactured by VARIAN MEDICAL SYSTEMS, INC.

• 10856100006223 - Gating Reflector Block: 2024-12-11
• 00850800006074 - Vitesee: 2024-11-11
• 00858086006467 - Varian Collimator Accessories 30 CM wedge set lower (JITKIT): 2024-10-07
• 00858086006474 - Varian Collimator Accessories 30 CM wedge set upper (JITKIT): 2024-10-07
• 00858086006481 - Varian Collimator Accessories 20 cm wedge set lower: 2024-10-07
• 00858086006498 - Varian Collimator Accessories Lead wedge set lower (JITKIT): 2024-10-07
• 00858086006504 - Varian Collimator Accessories Lead wedge set upper (JITKIT): 2024-10-07
• 00858086006511 - Varian Collimator Accessories Upper port film graticule for MLC: 2024-10-07