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 82



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. 


 

 

 

 

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