Head Neck Coil (Receive Only) – Bottom

GUDID 00868029000308

VIEWRAY INCORPORATED

Linear accelerator system Linear accelerator system Linear accelerator system Linear accelerator system Linear accelerator system Linear accelerator system Linear accelerator system Linear accelerator system Linear accelerator system Linear accelerator system Linear accelerator system Linear accelerator system

• Primary Device ID: 00868029000308
• NIH Device Record Key: b3ec48fa-a306-483d-b384-f0c1f709b963
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Head Neck Coil (Receive Only) – Bottom
• Version Model Number: 11765
• 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	00868029000308 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162393

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
• 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
• 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