Change Healthcare Stratus Imaging PACS

GUDID 17540262160147

Change Healthcare Canada Company

Radiological PACS software

• Primary Device ID: 17540262160147
• NIH Device Record Key: 33c67ca1-0270-43e7-87a0-a8868d12336d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Change Healthcare Stratus Imaging PACS
• Version Model Number: 1.4.6
• 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	17540262160147 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203249

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: 2024-07-08
• Device Publish Date: 2024-06-28

On-Brand Devices [Change Healthcare Stratus Imaging PACS]

• 17540262160017: 0.6.0
• 17540262160024: 0.7.0
• 17540262160031: 1.0.0
• 17540262160055: 1.0.1
• 17540262160048: 1.1.0
• 17540262160062: 1.1.1
• 17540262160079: 1.2.0
• 17540262160086: 1.3.0
• 17540262160093: 1.4.0
• 17540262160109: 1.4.1
• 17540262160116: 1.4.3
• 17540262160130: 1.4.5
• 17540262160147: 1.4.6