FDA WARNING_LETTER - Dornier Medtech America, Inc.

The FDA issued a Warning Letter to Dornier MedTech America, Inc. regarding their Dornier Opus II UIMS Digital Urology Imaging System. The FDA determined the firm is marketing this device in the U.S. without marketing clearance or approval, violating the Federal Food, Drug, and Cosmetic Act.

The firm previously obtained 510(k) clearance (K070123) for the TCA 5R / 5S Image Intensified Fluoroscopic Imaging Mobile C-Arm Systems, intended for general x-ray examinations. However, the Dornier Opus II UIMS, as described on the firm's website, is a "fully digital imaging system with enhanced patient access, exceptional imaging and advanced patient data management system," offering "next generation of digital imaging, data management and connectivity platform with UIMS." It provides "zero-bladder cutoff with unique overscan ideal for brachytherapy" and captures "high quality digital and fluoroscopic images."

This device is considered adulterated under section 501(f)(1)(B) of the Act because it lacks an approved premarket approval (PMA) or investigational device exemption (IDE). It is also misbranded under section 502(o) for failure to submit a 510(k) notification.

The FDA requires Dornier MedTech America, Inc. to immediately cease dissemination of all promotional materials for the Dornier Opus II UIMS, including removal from