510(k) K004037

X-RAY SYSTEM XR-MX by Karl Storz Endoscopy — Product Code JAA

K004037 is an FDA 510(k) premarket notification submitted by Karl Storz Endoscopy for the device "X-RAY SYSTEM XR-MX". The FDA issued a decision of Substantially Equivalent on February 2, 2001. The device falls under product code JAA (System, X-Ray, Fluoroscopic, Image-Intensified), a Class II device regulated under 21 CFR 892.1650. Karl Storz Endoscopy has at least 10 other 510(k) clearances on record.