Change Healthcare Stratus Imaging Viewer

GUDID 17540262130164

Change Healthcare Canada Company

Radiological PACS software

• Primary Device ID: 17540262130164
• NIH Device Record Key: 52a49099-bcdf-43f6-b1d8-63e86bfc8edb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Change Healthcare Stratus Imaging Viewer
• Version Model Number: 1.0.15
• 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	17540262130164 [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: 2023-10-27
• Device Publish Date: 2023-10-19

On-Brand Devices [Change Healthcare Stratus Imaging Viewer]

• 17540262130096: 1.0.8
• 17540262130102: 1.0.9
• 17540262130119: 1.0.10
• 17540262130126: 1.0.11
• 17540262130133: 1.0.12
• 17540262130140: 1.0.13
• 17540262130157: 1.0.14
• 17540262130164: 1.0.15
• 17540262130171: 1.0.16
• 17540262130188: 1.0.17
• 17540262130195: 1.0.18