Quality and Certifications

Dilon Technologies Inc. is an ISO 13485 certified company and works to ensure its products comply with necessary quality standards and certification requirements. Dilon’s medical imaging products also meet the UL 60601-1 and EN 60601-1 regulations.

Dilon’s medical imaging products have the following certifications:

Diagnostic Imaging:

The Dilon Molecular Breast Imaging System line of products:

The Dilon 6800® Gamma Camera with a 6×8 inches (15×20 cm) detector has 510(k) clearance and CE Mark.

The Dilon 6800 Acella® Gamma Camera with a 8×10 inches (20×25 cm) detector has 510(k) clearance and CE Mark.

The ergo™, Cardius® x.act with VCT Attenuation Correction, and the Cardius® XPO dedicated cardiac SPECT imaging systems has 510(k) clearance and CE Mark.

Surgical Imaging:

The declipseSPECT has 510(k) clearance and CE Mark.