New Mexico Software, Inc., a leading services provider of next-generation business and medical products, announced today that the company has obtained 510(k) clearance for its XR-EXpress Picture Archiving and Communication System (PACS) from the U.S. Food and Drug Administration (FDA).

 

XR-EXpress PACS is a teleradiology system designed to retrieve HIPAA (Health Insurance Portability and Accountability Act) compliant medical images in DICOM (Digital Imaging and Communications in Medicine) format. Also, it generates, organizes and archives textual reports while making them accessible across web networks with customized user interfaces.

This acknowledgement by the FDA allows New Mexico Software to begin a new level of marketing for its XR-EXpress in the U.S.

XR-EXpress will be targeted to hospitals, imaging centers, nursing homes, radiology reading practices, and authorized users who require patients’ images, demographics, and report information. FDA classified XR-EXpress as a Class II device under Regulation 21 CFR 892.2050 with product code LLZ.

President of the Healthcare division of New Mexico Software, Bruce Stabile said, "FDA clearance is required for nearly all medical devices to be marketed in the U.S. This definitely opens the door for future introductions to the US market of our other XR-Express medical products including video consultations and mobile phone applications."