RIT RIT113

GUDID 00857450006003

Dosimetry and QA Software

RADIOLOGICAL IMAGING TECHNOLOGY

Accelerator system quality assurance device

• Primary Device ID: 00857450006003
• NIH Device Record Key: db0e7c79-fdc7-450f-9f95-808458739b04
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RIT
• Version Model Number: 113
• Catalog Number: RIT113
• Company DUNS: 932395791
• Company Name: RADIOLOGICAL IMAGING TECHNOLOGY
• 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: false
• 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

Customer Support Contacts

• Phone: 719-590-1077
• Email: techsupport@radimage.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857450006003 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K935928

FDA Product Code

• IYE: Accelerator, Linear, Medical

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-03-31