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Carestream Submits FDA 510(k) Application for OnSight 3D Extremity Diagnostic System -

Carestream Health filed its FDA 510(k) application for the CARESTREAM OnSight 3D Extremity cone beam CT system for weight-bearing extremity imaging. The low-cost, low-dose system will target use by orthopaedic and sports medicine practices, hospitals, imaging centers, urgent care facilities and other healthcare providers.

U.S. and EU trials and research studies are underway, including an institutional IRB-approved clinical study designed to help orthopaedic surgeons more accurately and objectively diagnose the degree of patellar instability—an application noted at Carestream's initial debut of development for OnSight.

Source: Carestream Health

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