510(k) K981641

MAMMOGRAPHY X-RAY EQUIPMENT MODELS MGF101 AND MGF110, ALPHA III, ALPHA ST, ALPHA RT AND ALPHA IQ by Instrumentarium Corp. — Product Code IZH

K981641 is an FDA 510(k) premarket notification submitted by Instrumentarium Corp. for the device "MAMMOGRAPHY X-RAY EQUIPMENT MODELS MGF101 AND MGF110, ALPHA III, ALPHA ST, ALPHA RT AND ALPHA IQ". The FDA issued a decision of Substantially Equivalent on July 17, 1998. The device falls under product code IZH (System, X-Ray, Mammographic), a Class II device regulated under 21 CFR 892.1710. Instrumentarium Corp. has at least 10 other 510(k) clearances on record.