Regulatory Approvals & Quality Assurance
ASTRA Cloud-hosted Suite of Services has received U.S. FDA 510(k) Clearance
ImageGrid RT Viewer has received U.S. FDA 510(k) Clearance
ImageGrid PACS Appliance has received U.S. FDA 510(k) Clearance as a Class II Medical Device
ImageGrid PACS Appliance has received Health Canada Class II Medical Device License
ImageGrid PACS Appliance has received EU Class IIa CE Mark Medical Device - MDD 2007/47/EC
Candelis is a Certified EN ISO 13485:2003 Manufacturer.
Candelis Inc. is compliant with cGMPs in accordance with 21 CFR Part 820
Candelis Inc. is a U.S. FDA Registered Facility
Candelis is a participant in the Integrating the Healthcare Enterprise (IHE)
initiative of the RSNA and HIMSS organizations. ImageGrid
products are IHE-compliant.
The Candelis product line conforms to the Digital Imaging and
Communications in Medicine (DICOM) standard of the ACR
and NEMA organizations.