510(k) K974877

CRANEX TOME CEPH, OR CRANEX TOME by Orion Corporation Soredex — Product Code EHD

K974877 is an FDA 510(k) premarket notification submitted by Orion Corporation Soredex for the device "CRANEX TOME CEPH, OR CRANEX TOME". The FDA issued a decision of Substantially Equivalent on March 27, 1998. The device falls under product code EHD (Unit, X-Ray, Extraoral With Timer), a Class II device regulated under 21 CFR 872.1800. Orion Corporation Soredex has at least 3 other 510(k) clearances on record.