Monday, May 20, 2013
Google Custom Search

ClearCanvas Certifications

ClearCanvas offers commercial products that have received regulatory clearance. With patient care being of utmost importance to us, ClearCanvas' products are rigorously tested and developed within an ISO 13485-certified quality management system, ensuring our products are safe, reliable and useful. Our commercial products have been cleared for clinical use under US, Canadian and European Union regulations. Depending on your particular jurisdiction, use of the open source software may only be allowed for research and educational purposes.

 

European Union, Liechtenstein, Norway, Iceland, Switzerland

Full Quality Assurance Certificate No. CE 584804 for ClearCanvas RIS/PACS
Declaration of Conformity for ClearCanvas RIS/PACS
 

 

USA

510(k) Premarket Notification for ClearCanvas RIS/PACS Registration and Listing
510(k) Number: K110332
Regulation Number: 892.2050
 

 

CANADA

ISO 13485 Quality Management System Certificate

Health Canada MDALL ClearCanvas RIS/PACS Device Listing
Company ID: 130659
License No.: 81454

  

 

 

Copyright 2013 ClearCanvas Inc. All Rights Reserved