510(k) K173319

KaVo NOMAD Pro 2 Handheld X-ray System by Aribex — Product Code EHD

K173319 is an FDA 510(k) premarket notification submitted by Aribex for the device "KaVo NOMAD Pro 2 Handheld X-ray System". The FDA issued a decision of Substantially Equivalent on November 16, 2017. The device falls under product code EHD (Unit, X-Ray, Extraoral With Timer), a Class II device regulated under 21 CFR 872.1800. Aribex has at least 3 other 510(k) clearances on record.