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Virtual Imaging, a Canon Company, Receives ISO 13485:2003 Certification


MELVILLE, N.Y., November 8, 2017 – Bolstering its healthcare credentials, Canon U.S.A., Inc., a leader in digital imaging solutions, is proud to announce that the quality management system of Virtual Imaging Inc., has been registered by Intertek Testing Services NA, Inc., a Medical Device Single Audit Program (“MDSAP”) recognized auditing organization, as conforming to the requirements of ISO 13485:2003 for the design, manufacture, installation and service of digital radiographic x-ray systems.

In order to receive ISO 13485:2003 certification, an entity must demonstrate to an authorized third party that it meets the ISO requirements for a comprehensive quality management system for the design and manufacture of medical devices. Among the activities examined as part of the audit are design and development procedures, manufacturing of components, packaging, installation and service procedures, advisory notices or recalls and adverse event reporting.

MDSAP was developed, among other reasons, to enable appropriate regulatory oversight of an entity’s quality management system while minimizing the burden on industry. MDSAP allows a single audit of an entity’s quality management system by an MDSAP recognized auditor, such as Intertek, to satisfy the relevant regulatory requirements of the U.S. Food and Drug Administration, as well as the requirements of the relevant regulatory authorities in Australia, Brazil, Canada, and Japan, which are the other countries that participate in MDSAP. Virtual Imaging’s certification only includes the U.S. and Canada.

“Canon U.S.A. and Virtual Imaging are committed to the healthcare market and consistently strive to exceed expectations, which we hope to show with Virtual Imaging’s ISO 13485:2003 certification,” said Tsuneo Imai, vice president and general manager, Healthcare Solutions Division, Business Imaging Solutions Group, Canon U.S.A., Inc. and president, Virtual Imaging, Inc. “This certification indicates Virtual Imaging’s commitment to compliance with applicable quality management system requirements. Virtual Imaging takes pride in its ability to provide devices for its customers to help them meet the needs of their patients and to help provide a positive diagnostic imaging experience for all parties.”

For more information about radiography solutions from Virtual Imaging, please visit https://www.usa.canon.com/dr.

About Virtual Imaging, Inc.

Virtual Imaging, Inc., a Canon company, combines unmatched experience, extensive resources and broad business functions. Virtual Imaging collaborates with large complex hospitals, imaging centers, private physician offices and government organizations to support them in becoming efficient, high-performance healthcare providers and professionals with the latest in digital radiography technology. Virtual Imaging assists in the forward advancement of its clients, from strategic planning to day-to-day operations, with commitment to providing products and services for diagnostic equipment, imaging solutions and digital flat panel technology. In addition to healthcare organizations, Virtual Imaging also provides solutions to the U.S. veterinary sector and to the security industry – a field deployable radiography system for military use and a full-body security screening system to help address certain security needs of jails, prisons and other high-security environments.

About Canon U.S.A., Inc.

Canon U.S.A., Inc., is a leading provider of consumer, business-to-business, and industrial digital imaging solutions to the United States and to Latin America and the Caribbean markets. With approximately $29 billion in global revenue, its parent company, Canon Inc. (NYSE:CAJ), ranks third overall in U.S. patents granted in 2016.† Canon U.S.A. is committed to the highest level of customer satisfaction and loyalty, providing 100 percent U.S.-based service and support for all of the products it distributes in the United States. Canon U.S.A. is dedicated to its Kyosei philosophy of social and environmental responsibility. In 2014, the Canon Americas Headquarters secured LEED® Gold certification, a recognition for the design, construction, operations and maintenance of high-performance green buildings. To keep apprised of the latest news from Canon U.S.A., sign up for the Company's RSS news feed by visiting www.usa.canon.com/rss and follow us on Twitter @CanonUSA. For media inquiries, please contact pr@cusa.canon.com.

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Based on weekly patent counts issued by United States Patent and Trademark Office.

Doc No. MK-0323