Cleared Special

DBSWIN and VistaEasy Imaging Software

K161444 · Duerr Dental AG · Radiology
Jun 2016
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K161444 is an FDA 510(k) clearance for the DBSWIN and VistaEasy Imaging Software, a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ), submitted by Duerr Dental AG (Bietigheim-Bissingen, DE). The FDA issued a Cleared decision on June 21, 2016, 27 days after receiving the submission on May 25, 2016. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K161444 FDA.gov
FDA Decision Cleared SESE
Date Received May 25, 2016
Decision Date June 21, 2016
Days to Decision 27 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code LLZ — System, Image Processing, Radiological
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.2050