510(k) K980581

PLANMECA DIXI, DIGITAL INTRAORAL X-RAY IMAGING SYSTEM by Planmeca Oy — Product Code EHD

K980581 is an FDA 510(k) premarket notification submitted by Planmeca Oy for the device "PLANMECA DIXI, DIGITAL INTRAORAL X-RAY IMAGING SYSTEM". The FDA issued a decision of Substantially Equivalent on April 17, 1998. The device falls under product code EHD (Unit, X-Ray, Extraoral With Timer), a Class II device regulated under 21 CFR 872.1800. Planmeca Oy has at least 10 other 510(k) clearances on record.