Change Healthcare Enterprise Imaging Network™ Viewer

GUDID 17540262130034

Change Healthcare Canada Company

Radiology PACS software

• Primary Device ID: 17540262130034
• NIH Device Record Key: 9a0b8387-1c9e-414f-8148-87922547d76f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Change Healthcare Enterprise Imaging Network™ Viewer
• Version Model Number: 1.0.2
• Company DUNS: 246576391
• Company Name: Change Healthcare Canada Company
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	17540262130034 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181185

FDA Product Code

• LLZ: System, Image Processing, 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: 2021-03-12
• Device Publish Date: 2021-03-04

On-Brand Devices [Change Healthcare Enterprise Imaging Network™ Viewer]

• 17540262130034: 1.0.2
• 17540262130058: 1.0.4
• 17540262130065: 1.0.5
• 17540262130072: 1.0.6
• 17540262130089: 1.0.7