510(k) K142341

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

K142341 is an FDA 510(k) premarket notification submitted by Shimadzu Corp. for the device "X-RAY TV SYSTEM SONIALVISION G4". The FDA issued a decision of Substantially Equivalent on March 6, 2015. 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.