Notices

Trademarks

Synaptive, the Synaptive logo, BrightMatter, Bridge, ClearCanvas and the ClearCanvas logo, ImageDrive, Cleome and CleomeCast are trademarks of Synaptive Medical Inc., or its subsidiaries.

Third-Party Trademarks

Microsoft, Windows, Windows Server, SQL Server, Internet Explorer, .NET, .NET Framework and Silverlight are registered trademarks or trademarks of Microsoft Corporation.

Indications for Use

The ClearCanvas RIS/PACS is an image management system whose intended use is to provide scalable, DICOM compatible PACS solutions for hospitals and related institutions and sites, which will archive, distribute, retrieve, and display images and data from all hospital modalities (such as CR, CT, DR, MR, and other devices) and information systems. This also includes the display of structured reports and mammography images that have been created according to DICOM "For Presentation", and will include standard features and other tools for analyzing mammography images.

Lossy compressed mammography images and digitized film screen images must not be used for primary image interpretations. Mammography images may only be interpreted using an FDA approved monitor that offers at least 5 mega-pixel resolution and meets other technical specifications approved by the FDA.

Contraindications

Caution: For Prescription Use Only (US Regulation 21 CFR 801.109). Federal law restricts this device to sale by or on the order of a physician.

Intended Environments of Use

Application areas include imaging centres, radiologist reading rooms, referring physicians' offices and other locations where trained medical professionals would require or desire access to patient images, demographic information, or other patient medical information that has been stored in the system. ClearCanvas RIS/PACS is intended to be used by qualified medical personnel only.

Caution: The ClearCanvas RIS/PACS, as released and sold by Synaptive Medical, is a licensed medical device. Evaluation versions and software derived from ClearCanvas open source projects are neither intended nor licensed for clinical use, and should only be used as permitted by applicable and governing regulations.

Synaptive Medical
MaRS Discovery District
101 College Street, Suite 200
Toronto, ON M5G 1L7
Canada
www.synaptivemedical.com