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.
What does it mean?

EN ISO 13485:2003
Certificate Number: 2106759 verified by Kema Quality B.V.

USA
Substantial Equivalence has been determined by the FDA and accordingly, Orthocrat is cleared for marketing in the USA.

FDA 510(k): KO42816

Canada
Canadian Medical Device Establishment License

Israel
AMAR Certification (Medical Device Department Certification) Certificate Nomber: 13110000

IHE
Conformance with IHE is a top priority in the development of Orthocrat's clinical planning solution. Orthocrat 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.

To view our IHE integration statement in PDF format, please click here.

DICOM
To view our DICOM conformance statement in PDF format, please click here.

Intellectual Property

Orthocrat has a US patent pending US application Serial No. 10/647,796