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Imaging Sciences Earns ISO 9001:2000 and ISO

January 31, 2005

Imaging Sciences International, a developer and manufacturer of advanced dental and maxillofacial radiography products, has announced that the International Organization for Standardization (ISO) has awarded ISO 9001:2000 and ISO 13485:2003 certifications to the company.

As part of the company's aggressive expansion into the global marketplace, ISO 9001:2000 and 13485:2003 position Imaging Sciences to continually meet the increasing demand for quality advanced dental imaging systems. The ISO certifications further facilitate Imaging Sciences' accreditation to do business in the European Union and Asian markets, where dental professionals are increasingly demanding Imaging Sciences' i-CAT advanced 3-D imaging technology.

In addition to meeting the FDA Part 820 of the Code of Federal Regulations (21 CFR Part 820), the company recently earned the Canadian Medical Devices Regulations and the European Union Medical Device Directive, CE-MDD 93/42/EEC, for quality assurance requirements.