Change Healthcare Anatomical AI™

GUDID 17540262150018

Change Healthcare Canada Company

Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software

• Primary Device ID: 17540262150018
• NIH Device Record Key: 2853dd0c-ae1c-4ece-b5c7-6ae1836dddf3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Change Healthcare Anatomical AI™
• Version Model Number: 1.0.0
• 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	17540262150018 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210719

FDA Product Code

• QIH: Automated Radiological Image Processing Software

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: 2021-08-17
• Device Publish Date: 2021-08-09

Devices Manufactured by Change Healthcare Canada Company

• 17540262090130 - Change Healthcare Cardiology: 2024-02-16
• 17540262100129 - Change Healthcare Cardiology Hemo: 2024-02-16
• 17540262110128 - Change Healthcare Cardiology ECG Management: 2024-02-16
• 17540262170023 - Change Healthcare Cardiology Hemodynamics: 2024-02-16
• 17540262130171 - Change Healthcare Stratus Imaging Viewer: 2023-12-28
• 17540262010053 - Change Healthcare Enterprise Viewer: 2023-11-29
• 17540262030051 - Change Healthcare Radiology Solutions: 2023-11-20
• 17540262180046 - Change Healthcare Mammography Plus: 2023-11-20