Letter to: Xoran MiniCAT customers
Re: IAC communication regarding NEMA XR-29-2013
Dear Xoran Customer,
It has come to Xoran’s attention that CMS is planning to exempt cone beam CT (CBCT) from NEMA XR-29-2013. However, we have not yet seen this officially issued. Furthermore, the Medical Imaging & Technology Alliance (MITA), a division of NEMA that is responsible for promoting policy that includes CT scanners, is currently in the process of defining CBCT as a subcategory of Computed Tomography equipment. Xoran is actively participating along with other manufacturers in the MITA work group and we believe the MiniCAT is likely to be included in the CBCT category once it is formally established.
Xoran, as the pioneer and market leader for low-radiation medical point-of-care CT scanners, remains committed to ALARA, smart dose management, and conformance to relevant NEMA guidelines. The MiniCAT is an FDA 510(k) cleared medical device registered as a CT system (FDA product code JAK) as identified in 21 CFR Part 892. Xoran’s MiniCAT is designed to conform to NEMA XR-29-2013 guidelines since January 1, 2016.
A statement of conformance for your MiniCAT to NEMA XR-29-2013 guidelines is provided upon request. Please contact Xoran’s customer service at 800-709-6726.
Sincerely,
Laura Dennis, Director of Sales and Marketing
and all of us at Xoran Technologies
laura@xorantech.com
800.709.6726
