Cleared Traditional

RX DC

K163519 · Cefla S.C. · Radiology
Jan 2017
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K163519 is an FDA 510(k) clearance for the RX DC, a Unit, X-ray, Extraoral With Timer (Class II — Special Controls, product code EHD), submitted by Cefla S.C. (Imola, IT). The FDA issued a Cleared decision on January 13, 2017, 29 days after receiving the submission on December 15, 2016. This device falls under the Radiology review panel. Regulated under 21 CFR 872.1800.

Submission Details

510(k) Number K163519 FDA.gov
FDA Decision Cleared SESE
Date Received December 15, 2016
Decision Date January 13, 2017
Days to Decision 29 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code EHD — Unit, X-ray, Extraoral With Timer
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.1800

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