510(k) K242948

Adora DRFi (04550010) by Nrt X-Ray A/S — Product Code JAA

K242948 is an FDA 510(k) premarket notification submitted by Nrt X-Ray A/S for the device "Adora DRFi (04550010)". The FDA issued a decision of Substantially Equivalent on December 23, 2024. The device falls under product code JAA (System, X-Ray, Fluoroscopic, Image-Intensified), a Class II device regulated under 21 CFR 892.1650. Nrt X-Ray A/S has at least 1 other 510(k) clearance on record.