Carestream submits OnSight 3D Extremity System for FDA clearance
Carestream Health has announced the filing of a 510(k) application with the FDA for clearance of its OnSight 3D Extremity System, according to a company press release.
The system, which uses cone beam CT technology to capture images of patient extremities, is designed to offer affordable yet high-quality low-dose 3D imaging.
“Orthopaedic imaging is a major focus for Carestream because of the prevalence of musculoskeletal conditions among people of all ages,” said Helen Titus, a marketing director with the Rochester, N.Y.-based healthcare company. “Our goal is to offer a compact, affordable imaging system that enables a variety of healthcare providers to produce extremely high-quality 3D images of extremities including weight-bearing exams.”
The OnSight 3D Extremity System is designed for use by orthopaedic and sports medicine practices, hospitals, imaging centers, urgent care facilities and other healthcare providers, and is currently being tested in trials and research studies in the United States and Europe.
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