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Carestream gets FDA approval for OnSight 3D extremity system

Carestream Health has received 510(k) clearance from the US Food and Drug Administration (FDA) for its OnSight 3D extremity system.

The system uses cone beam CT (CBCT) technology to acquire weight-bearing and other types of extremity exams.

Carestream’s new compact system can be used to carry out lower-dose 3D imaging studies by orthopaedic and sports medicine practices, hospitals, imaging centers, urgent care facilities and other healthcare providers.

The extremity imaging system also enables patients to view a 3D image that illustrates their condition or injury, helping them to realize the reason for a treatment or surgical procedure. 

In March, the company filed a 510(k) application with the FDA for clearance of the OnSight 3D extremity system.

The firm will showcase the new imaging system at the American Society for Surgery of the Hand (ASSH) conference, which starts on 29 September.

Carestream ultrasound and CT solutions worldwide marketing director Helen Titus 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.”


Image: Carestream’s OnSight 3D extremity system. Photo: courtesy of Carestream Health.