Ethos™ Treatment Planning

GUDID 00856100006264

VARIAN MEDICAL SYSTEMS, INC.

Radiation therapy software

• Primary Device ID: 00856100006264
• NIH Device Record Key: fb686a0b-9555-4a37-a517-323868fa8ccd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ethos™ Treatment Planning
• Version Model Number: 1.1
• 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	00856100006264 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212294

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: 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.

• 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
• 00858086006528 - Varian Collimator Accessories Upper port film graticule for MLC: 2024-10-07
• 00858086006535 - Varian Collimator Accessories Lower port film graticule for MLC: 2024-10-07