MRIdian Linac System

GUDID 00868029000346

VIEWRAY INCORPORATED

Stereotactic teletherapy radionuclide system, MRI-imaging

• Primary Device ID: 00868029000346
• NIH Device Record Key: 6b00966f-f2ef-44dc-af0b-9c2c68ae4cba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MRIdian Linac System
• Version Model Number: 20000-01
• Company DUNS: 015705677
• Company Name: VIEWRAY INCORPORATED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00868029000346 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212958

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: 2022-05-16
• Device Publish Date: 2022-05-06

Devices Manufactured by VIEWRAY INCORPORATED

• 00868029000308 - Head Neck Coil (Receive Only) – Bottom: 2022-05-16
• 00868029000315 - Medium Torso Coil (Receive Only) – Bottom: 2022-05-16
• 00868029000346 - MRIdian Linac System: 2022-05-16
• 00868029000346 - MRIdian Linac System: 2022-05-16
• 00868029000353 - Head Neck Coil (Receive Only) – Top: 2022-05-16
• 00868029000360 - Medium Torso Coil (Receive Only) – Top: 2022-05-16
• 00868029000391 - Head Coil (Receive Only): 2022-05-16
• 00850036816027 - MRIdian A3i Software: 2022-05-13