Cleared Traditional

Planmed Verity

K143435 · Planmed OY · Radiology
May 2015
Decision
164d
Days
Class 2
Risk

About This 510(k) Submission

K143435 is an FDA 510(k) clearance for the Planmed Verity, a X-ray, Tomography, Computed, Dental (Class II — Special Controls, product code OAS), submitted by Planmed OY (Helsinki, FI). The FDA issued a Cleared decision on May 14, 2015, 164 days after receiving the submission on December 1, 2014. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1750.

Submission Details

510(k) Number K143435 FDA.gov
FDA Decision Cleared SESE
Date Received December 01, 2014
Decision Date May 14, 2015
Days to Decision 164 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code OAS — X-ray, Tomography, Computed, Dental
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1750
Definition Produce Cross-sectional Diagnostic X-ray Images Of The Intra-oral Tissue And Teeth.