510(k) K991455

ORTHOSLICE OS1000 SERIES; PANORAMIC ORTHOSLICE OS 1000: OS1000, OS1000E PANORAMIC AND CEPHALOMETRIC ORTHOSLICE OS1000C, by Trophy Radiologie — Product Code EHD

K991455 is an FDA 510(k) premarket notification submitted by Trophy Radiologie for the device "ORTHOSLICE OS1000 SERIES; PANORAMIC ORTHOSLICE OS 1000: OS1000, OS1000E PANORAMIC AND CEPHALOMETRIC ORTHOSLICE OS1000C,". The FDA issued a decision of Substantially Equivalent on June 25, 1999. The device falls under product code EHD (Unit, X-Ray, Extraoral With Timer), a Class II device regulated under 21 CFR 872.1800. Trophy Radiologie has at least 10 other 510(k) clearances on record.