510(k) K233380

TRIDENT Mobile Fluoroscopy System by Dornier Medtech America — Product Code JAA

K233380 is an FDA 510(k) premarket notification submitted by Dornier Medtech America for the device "TRIDENT Mobile Fluoroscopy System". The FDA issued a decision of Substantially Equivalent on June 26, 2024. The device falls under product code JAA (System, X-Ray, Fluoroscopic, Image-Intensified), a Class II device regulated under 21 CFR 892.1650. Dornier Medtech America has at least 10 other 510(k) clearances on record.