IMRISmatrix 5.0

GUDID 00857534006868

Applications Platform 5.0 3 Room, North America, Japan

IMRIS Imaging, Inc.

Operating room audiovisual data/device management system application software

• Primary Device ID: 00857534006868
• NIH Device Record Key: 0d1470e7-249a-454b-9525-83cdaad2cce8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IMRISmatrix 5.0
• Version Model Number: P122309
• Company DUNS: 079990922
• Company Name: IMRIS Imaging, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857534006868 [Primary]

FDA Product Code

• LMB: Device, Digital Image Storage, Radiological

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: 2025-09-26
• Device Publish Date: 2025-09-18

On-Brand Devices [IMRISmatrix 5.0]

• 00857534006875: Applications Platform 5.0 2 Room, North America, Japan
• 00857534006868: Applications Platform 5.0 3 Room, North America, Japan