510(k) K992385

ORTHOPANTOMOGRAPH OP100D by Instrumentarium Corp. — Product Code MUH

K992385 is an FDA 510(k) premarket notification submitted by Instrumentarium Corp. for the device "ORTHOPANTOMOGRAPH OP100D". The FDA issued a decision of Substantially Equivalent on September 28, 1999. The device falls under product code MUH (System, X-Ray, Extraoral Source, Digital), a Class II device regulated under 21 CFR 872.1800. Instrumentarium Corp. has at least 10 other 510(k) clearances on record.