FDA Clearance for Carestream’s OnSight 3D Extremity System

By Julie A. Vetalice

Carestream Health received FDA 510(k) clearance for the OnSight 3D Extremity System to capture weight-bearing and other types of extremity exams. The product is available immediately.

The compact cone beam CT-based system offers high-quality, low-dose 3D imaging for use by orthopaedic and sports-medicine practices, hospitals, imaging centers, urgent care facilities, etc. Providers can capture images and conduct patient consultation within a single visit.

Carestream announced development of the system in 1Q15, with initial clinical studies focusing on its use to diagnose knee injuries. The company filed its 510(k) submission one year later.

The system will be displayed at the 2016 American Society for Surgery of the Hand (ASSH) conference.

Sources: Carestream Health; ORTHOWORLD Inc.

Tags: 510(k) Clearance, Regulatory