Regulatory Affairs 

USA - Substantial Equivalence has been determined by the FDA and accordingly, OrthoView is cleared for marketing in the USA. FDA 510(k): KO32401

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

Canada - Establishment license number 1750

Australia - Establishment license number 42058

Contact Meridian Technique for latest information on countries of registration

Meridian Technique operates and maintains an ISO9001:2000 and ISO13485 compliant quality management system

DICOM
OrthoView is able to read and write DICOM Part 10 media files. Through the integrated PACS client software it is able to query a DICOM archive, retrieve DICOM images and save the results of planning and templating back to the DICOM archive. Some versions are also able to query, receive and send images over the DICOM network. DICOM images originating from CR or DX modalities can be displayed. Where relevant, greyscale, single frame images from other modalities can also be displayed.

OrthoView DICOM output is in the form of colour or optionally monochrome, Secondary Capture images which can be viewed on any standard DICOM viewer. Two types of images are produced:

1. A single original image containing a textual record of the OrthoView session including details of the operator, planning results and templates used
2. One image per original X-ray with templates burned in in colour or white.

If a report image is opened in OrthoView itself, the full planning session is regenerated allowing the operator to resume working where they left off.

OrthoView has an extensive set of configuration options to ensure that the generated images are easily identified and selected on any PACS viewer.

To view our DICOM conformance statement in pdf format, please Click here.

HIPAA
OrthoView is committed to helping our customers comply with the HIPAA Regulations and our orthopaedic digital imaging software has security safeguards to protect the privacy, confidentiality and integrity of the electronic protected health information it receives from its customers. We believe that these safeguards, which include encryption, anonimisation and automatic shutdown, exceed the required measures necessary under the privacy and security regulations of HIPAA.