iDMS Data Management System NA

GUDID 00811376030085

IDMS Data Management System (Version 3.0)

ACCURAY INCORPORATED

Patient health record information system application software

• Primary Device ID: 00811376030085
• NIH Device Record Key: 38ee4274-b684-4cc2-ba28-ba3c6661a69f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iDMS Data Management System
• Version Model Number: 1061514
• Catalog Number: NA
• Company DUNS: 785961244
• Company Name: ACCURAY INCORPORATED
• 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: false
• Manufacturing Date: false
• 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

Customer Support Contacts

• Phone: 408-716-4600
• Email: webhelp@accuray.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00811376030085 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161144

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: 2019-06-10
• Device Publish Date: 2019-05-31

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