510(k) K033624

PACS SOFTWARE SOLUTION 2003 by Canon USA, Inc. — Product Code LLZ

K033624 is an FDA 510(k) premarket notification submitted by Canon USA, Inc. for the device "PACS SOFTWARE SOLUTION 2003". The FDA issued a decision of Substantially Equivalent on December 15, 2003. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Canon USA, Inc. has at least 10 other 510(k) clearances on record.