Sharp pd medical company’s high-resolution computer breast digital radiography system achieves the FDA approval letter.

     Sharp pd ‘s DirectView breast radiation imaging functions permit user to get breast radiation image by digital way, at the same time it can use medical and health institutions’ existing breast imaging medical x-ray machine. Once the FDA approved a final product labels, sharpen pd medical can begin to sale and distribute this DR breast radiography imaging system in U.S. commerce.

     In the meantime the FDA changed III or high-risk digital breast imaging equipment classification, sharp pd medical publish a announce that need a approval application to divide those what only need 510 (k) certification level II or medium risk equipment before appeared in the market.

本文由廣州佳譽醫(yī)療器械有限公司編輯