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

FDA 510(k): KO42816

EU
Orthocrat is CE marked as a Class 1 medical device according to 93/42/EEC-Medical Device Directive

Canada
Canadian Medical Device Establishment License

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