| ImageGrid PACS Appliance has received U.S. FDA 510(k) Clearance as a Class II Medical Device |
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| ImageGrid PACS Appliance has received Health Canada Class II Medical Device License |
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| ImageGrid PACS Appliance has received EU Class IIa CE Mark Medical Device - MDD 2007/47/EC |
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| Candelis is a Certified EN ISO 13485:2003 Manufacturer. |
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| Candelis Inc. is compliant with cGMPs in accordance with 21 CFR 820 |
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| Candelis Inc. is a U.S. FDA Registered Facility |
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| Candelis is a participant in the Integrating the Healthcare Enterprise (IHE) initiative of the RSNA and HIMSS organizations. ImageGrid products are IHE-compliant. |
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| 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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