| Certificates | |
|---|---|
| Certificates |
CE 0344
TraumaCad is CE marked as a Class 1 medical device according to 93/42/EEC-Medical Device Directive Certificate Number: 2113639CE01 verified by Kema Quality B.V.
EN ISO 13485:2003
Certificate Number: 2106759 verified by Kema Quality B.V.
CAN/CSA ISO 13485:2003
Certificate Number: 2106759 verified by Kema Quality B.V.
|
| USA |
FDA 510(k): K073714Substantial Equivalence has been determined by the FDA and accordingly, Voyant Health is cleared for marketing in the USA. |
| Israel |
AMAR Certification (Medical Device Department Certification) Certificate Nomber: 13110000
|
| IHE |
Conformance with IHE is a top priority in the development of Voyant Health’s clinical planning solution. Voyant Health participates in the IHE Connectathon events. The IHE Integration Statements below specify the capabilities in terms of the key concepts of IHE: Actors and Integration Profiles. The Statement describes the intended conformance of TraumaCad with the IHE Technical Framework. IHE integration statement |
| DICOM | |
| Intellectual Property |
Voyant Health has a US patent pending US application Serial No. 10/647,796 |
