Carestream Health said today it won FDA 510(k) clearance for its OnSight 3D extremity system.
The Rochester, N.Y.-based company’s newly cleared device uses cone beam CT tech to capture weight-bearing and other types of extremity exams. The system is designed for use by orthopaedic and sports medicine practices, hospitals, imaging centers, urgent care facilities and other healthcare providers, the company said.
“Our extremity imaging system can help in treating a host of orthopaedic conditions that affect the biomechanical behavior of the joints such as arthritis, meniscus loss, instability and malalignment syndromes. This new system offers less radiation than traditional CT systems while delivering excellent image quality. Youth and adults often suffer sports-related injuries to their knees, ankles and feet while older adults experience arthritis, joint instability, meniscus loss and other conditions,” ultrasound & CT solutions worldwide marketing director Helen Titus said in a prepared statement.
Carestream said the device allows patients to view 3D images to help illustrate conditions or injuries and aid in understanding the need for treatment or surgical procedures.
In March, the company said it filed a 510(k) application with the FDA seeking clearance for its OnSight 3D Extremity System cone-beam based extremity CT imaging device.
Carestream said it was conducting trials and research studies of the CBCT system in the U.S. and Europe, with an IRB approved clinical study ongoing at the University of Buffalo’s UBMD investigating the use of the device to diagnose the degree of instability of the patella.