A Look Back
The improved commercial version of Koning Vera was FDA-approved in 2017, and the AMA authorized the dedicated breast CT CPT code for diagnostic use in January 2021.
Our Koning Vera is the first ever commercially available low dose, 3D breast CT scanner designed specifically to image the entire breast with a single scan without compression of the breast tissue. It acquires hundreds of images in seconds, producing “true” 3D images with excellent patient comfort and completely eliminated compression.
The Koning Vera introduces the opportunity to save lives and alter the face of breast cancer as we know it through pain-free and early detection.
Our FDA Clearance
The Koning Vera is the only FDA PMA approved breast CT.
Koning Vera has undergone and successfully completed all aspects of the FDA's rigorous Pre- Market Approval (PMA) process for medical devices. We used clinical evidence to prove our device’s safety and effectiveness, and are incredibly proud to be the only no-compression, true 3D breast imaging device manufacturer with FDA diagnostic approval.
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