New Mexico Software, a services provider of business and medical products, has obtained a 510(k) clearance from the FDA for its XR-EXpress PACS.
XR-EXpress PACS is a teleradiology system designed to retrieve HIPAA-compliant medical images in DICOM format, according to the Albuquerque, N.M.-based company. Also, the system generates, organizes and archives textual reports while making them accessible across web networks with customized user interfaces.
The company said its 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.