Ashva Technologies Limited announced today that the United States Food & Drug Administration (FDA) has cleared the Edge PACS solution for marketing in USA. All of the Edge PACS components including Server, Web viewer & DICOM workstation have been awarded FDA 510(k).
Edge PACS has received FDA 510(k) clearance for diagnostic viewing and manipulating medical images. It can be used for receiving and storing digital images and data from various modalities (including CT, MR, US, RF units, CR, DR, etc) and various other sources (like secondary capture devices, scanners, imaging gateways or other imaging sources). The images and data thus received can be displayed, processed, stored and communicated across computer networks using this software.
The Edge PACS can be fully integrated with an institution's existing HIS or RIS providing access to reports for fully integrated electronic patient records.
Mr.Mohan Mysore, CEO ? Americas also said that he is very happy that Ashva's PACS has got the accreditation that it rightly deserves. "FDA 510(k) approval of the Edge PACS (Server, Web viewer and DICOM workstation) demonstrates Ashva's commitment to provide high standard-quality products, developed under a stringent quality management system, for the benefit of our partners' product development and end user's ease of use."
Mohan Mysore, CEO ? Americas quoted "We are very pleased to offer this additional value to our esteemed customers. Even though we were accredited as one of the Top 5 PACS companies in India by Frost and Sullivan, we strongly felt that we need to have the FDA 510(k) clearance to be ready for the US market. The clearance is a testament to the fact that Ashva's PACS solution is upto the International standards of quality and usability. We believe that there is no other product in the market at this price range packed with so many features and with a FDA clearance."
