510(k) K952313

VARIS IMAGES, INCLUDING XIMATRON DIGITAL IMAGING OPTION by Varian Assoc., Inc. — Product Code LLZ

K952313 is an FDA 510(k) premarket notification submitted by Varian Assoc., Inc. for the device "VARIS IMAGES, INCLUDING XIMATRON DIGITAL IMAGING OPTION". The FDA issued a decision of Substantially Equivalent on August 16, 1995. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Varian Assoc., Inc. has at least 10 other 510(k) clearances on record.