510(k) K043379

SHIMADZU SURGICAL MOBILE C-ARM IMAGING X-RAY SYSTEM, MODEL WHA-200 by Shimadzu Corp. — Product Code OXO

K043379 is an FDA 510(k) premarket notification submitted by Shimadzu Corp. for the device "SHIMADZU SURGICAL MOBILE C-ARM IMAGING X-RAY SYSTEM, MODEL WHA-200". The FDA issued a decision of Substantially Equivalent on February 17, 2005. The device falls under product code OXO (Image-Intensified Fluoroscopic X-Ray System, Mobile), a Class II device regulated under 21 CFR 892.1650. Shimadzu Corp. has at least 10 other 510(k) clearances on record.