510(k) K131075

X-RAY TV SYSTEM SONIAL VISION G4 by Shimadzu Corp. — Product Code JAA

K131075 is an FDA 510(k) premarket notification submitted by Shimadzu Corp. for the device "X-RAY TV SYSTEM SONIAL VISION G4". The FDA issued a decision of Substantially Equivalent on March 28, 2014. The device falls under product code JAA (System, X-Ray, Fluoroscopic, Image-Intensified), a Class II device regulated under 21 CFR 892.1650. Shimadzu Corp. has at least 10 other 510(k) clearances on record.