Carestream Health has filed a 510(k) application with the U.S. Food and Drug Administration (FDA) for clearance of its Carestream OnSight 3D extremity imaging system.
The Carestream OnSight features conebeam CT technology and is designed to acquire weight-bearing images and perform other types of patient extremity exams. It provides low-dose 3D imaging for orthopedic and sports medicine practices, hospitals, imaging centers, urgent care facilities, and other healthcare providers.
Carestream currently is conducting trials and research studies of the scanner in the U.S. and Europe, including an institutional clinical study designed to help orthopedic surgeons more accurately and objectively diagnose the degree of instability in a knee cap.
