510(k) K993958

IDX-60 INTRAORAL X-RAY by X-Cel X-Ray Corp. — Product Code MUH

K993958 is an FDA 510(k) premarket notification submitted by X-Cel X-Ray Corp. for the device "IDX-60 INTRAORAL X-RAY". The FDA issued a decision of Substantially Equivalent on February 14, 2000. The device falls under product code MUH (System, X-Ray, Extraoral Source, Digital), a Class II device regulated under 21 CFR 872.1800. X-Cel X-Ray Corp. has at least 3 other 510(k) clearances on record.