ISO 27001 Registered Information Security Management System
Certificate Number: IS 634314
NovaPACS is CE marked as a Class IIa medical device according to 93/42/EEC-Medical Device Directive Certificate Number: 584245
EHR Certified Technology for Hospitals – Certificate #CC-1112-100046-1 (July 6, 2012)
EHR Certified Technology for Eligible Providers – Certificate #CC-1112-100046-2 (July 6, 2012)
This EHR Module is ONC-ATCB 2011/2012 compliant and has been tested and certified by, the Certification Commission for Health Information Technology (CCHIT®), an ONC-ATCB, in accordance with the applicable certification criteria adopted by the Secretary of Health and Human Services. This certification does not represent an endorsement by the U.S. Department of Health and Human Services or guarantee the receipt of incentive payments.
Substantial Equivalence has been determined by the FDA and accordingly, NovaPACS is cleared for marketing in the USA.
FDA 510(k): K171754