Legal and Regulatory Information
Regulatory
ShowCase has received US FDA clearance as a Class II Medical Device.
The K number for this product is K082135.
ShowCase does not have a Health Canada Medical Device License. As a result, we cannot ship to Canada.
Intended Use Statement
ShowCase is diagnostic quality radiological viewing software. ShowCase can be used to receive, store, display, and manipulate medical images and associated clinical data. ShowCase is not intended for diagnosis of lossy compressed images.
Caution: Federal law restricts this device to sale or use by or on the order of a physician.
Trademark
SHOWCASE is a trademark registered in the U.S. Patent office by Trillium Technology, Inc., Ann Arbor, Michigan.