Mar 5 2010
Dilon Diagnostics, a manufacturer and supplier of high-resolution molecular imaging systems, announced today that it has received ISO 13485 certification.
The certification confirms Dilon's commitment to continual improvement of products, customer satisfaction, compliance with statutory and regulatory requirements and risk management.
ISO 13485 is an internationally recognized standard system which defines the requirements for design, development, production, and distribution of medical devices. It ensures conformity with specified quality controls in the development of safe and effective medical devices.
The Dilon 6800 Gamma Camera, Dilon's cornerstone product, is a high-resolution, small field-of-view gamma camera optimized to perform Breast-Specific Gamma Imaging (BSGI). BSGI is a molecular breast imaging procedure that aids in the effective management of suspicious and difficult-to-interpret breast cases. The Dilon 6800 captures vital information by viewing the metabolic activity in the breast; it can identify lesions independent of tissue density and is capable of duplicating standard mammographic views. In addition the Dilon GammaLoc™ system, an accessory to the Dilon 6800®, is the only FDA-cleared localization device that enables gamma-guided, minimally invasive needle biopsy of suspicious lesions identified with BSGI.
Dilon's recent distribution agreement with Philips, allows the renowned healthcare company to sell and support the Dilon products in European and key Middle Eastern markets. The partnership with the global leader in medical technology demonstrates the significant endorsement of MBI/BSGI and its continued commitment to deliver the most advanced women's health solutions worldwide.
Source: http://www.dilon.com