Quality & CertificationsDilon works to ensure its products comply with necessary quality standards and certification requirements. The Dilon 6800® Gamma Camera has acquired FDA 510(k) clearance, CE Mark, UL Recognition, and ISO 13485 Certification.FDA 510(k) AuthorizationThe Dilon camera was granted 510(k) clearance by the U.S. Food and Drug Administration in 1999 following initial work at Johns Hopkins University Medical Center and is commercially available in the U.S.CE MarkThe CE marking recognizes that the Dilon 6800 Gamma Camera conforms to essential health and safety requirements of the European Directives, and allows product distribution throughout Europe. After two years of rigorous tests, performance and product revisions, Dilon achieved this recognition in March 2008. The CE label certification is essential to expanding access to the Dilon 6800 Gamma Camera in Europe and worldwide.UL RecognitionUnderwriter’s Laboratories Inc. certification is the U.S. national standard for safety testing of electrical medical devices. Most hospitals will not allow installation of medical devices in their facilities without proof of the equipment meeting the UL 60601-1 regulation. Dilon received UL approval in April 2008.ISO 13485 CertificationTo receive certification from the International Organization for Standardization, an organization must demonstrate its ability to provide medical devices that consistently meet customer and regulatory requirements. |
