Standards and Regulatory Approvals

Candelis is a participant in the Integrating the Healthcare Enterprise (IHE) initiative of the RSNA and HIMSS organizations. ImageGrid products are IHE-compliant.

Candelis products conforms to the Digital Imaging and Communications in Medicine (DICOM) standard of the ACR and NEMA organizations.
Candelis has achieved ISO 13485:2003 certification, representing official recognition of our well-established Quality Management System. Candelis ImageGrid PACS has received U.S. FDA 510(k) Clearance as a Class II Medical Device. Candelis ImageGrid PACS has received Health Canada Approval as a Class II Medical Device.