Swissray expects 510(k) clearance for direct digital radiography system in December.
This article was originally published in The Gray Sheet
Executive Summary
SWISSRAY ADDON-MULTI-SYSTEM DIRECT DIGITAL RADIOGRAPHY SYSTEM CLEARANCE is expected in December following the Nov. 21 510(k) approval of the AddOn-Bucky direct x-ray detector component, the firm says. The complete system, for which a 510(k) was submitted in January, is intended to perform most general x-ray applications. Swissray International says it plans to use its own reps and distributors to market the $380,000-400,000 system.