510(k) K973642

ORTHOPANTOMOGRAPH OP100 AND ORTHOCEPH OC100 by Instrumentarium Imaging, Inc. — Product Code EHD

K973642 is an FDA 510(k) premarket notification submitted by Instrumentarium Imaging, Inc. for the device "ORTHOPANTOMOGRAPH OP100 AND ORTHOCEPH OC100". The FDA issued a decision of Substantially Equivalent on November 21, 1997. The device falls under product code EHD (Unit, X-Ray, Extraoral With Timer), a Class II device regulated under 21 CFR 872.1800. Instrumentarium Imaging, Inc. has at least 10 other 510(k) clearances on record.