Varian Acuity with Conebeam Computed Tomography TM64001000

GUDID 00856545006010

VARIAN MEDICAL SYSTEMS, INC.

Radiation therapy simulation system Radiation therapy simulation system Radiation therapy simulation system Radiation therapy simulation system Radiation therapy simulation system Radiation therapy simulation system Radiation therapy simulation system Radiation therapy simulation system Radiation therapy simulation system Radiation therapy simulation system Radiation therapy simulation system Radiation therapy simulation system Radiation therapy simulation system Radiation therapy simulation system Radiation therapy simulation system Radiation therapy simulation system

• Primary Device ID: 00856545006010
• NIH Device Record Key: 2b7fbd19-46ed-412e-8a89-8447a2a3429a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Varian Acuity with Conebeam Computed Tomography
• Version Model Number: 2.1
• Catalog Number: TM64001000
• 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	00856545006010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K033339

FDA Product Code

• KPQ: System, simulation, radiation therapy

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: 2020-06-12
• Device Publish Date: 2020-06-04

Devices Manufactured by VARIAN MEDICAL SYSTEMS, INC.

• 00856100006158 - Visual Coaching Device (VCD): 2023-11-22
• 00850800006067 - VariSeed: 2023-09-25
• 00858086006801 - IDENTIFY: 2023-08-14
• 00855141006202 - Eclipse Treatment Planning System: 2023-08-07
• 00899475002042 - Clinac iX: 2023-06-20
• 00899475002066 - Trilogy: 2023-06-20
• 00899475002080 - Novalis Tx: 2023-06-20
• 00810563021066 - Embozene Color Advance 40um Embozene 2mL Colored - US: 2023-05-29