Cleared Traditional

Planmed Verity

K180918 · Planmed OY · Radiology
Nov 2018
Decision
235d
Days
Class 2
Risk

About This 510(k) Submission

K180918 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 November 30, 2018, 235 days after receiving the submission on April 9, 2018. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1750.

Submission Details

510(k) Number K180918 FDA.gov
FDA Decision Cleared SESE
Date Received April 09, 2018
Decision Date November 30, 2018
Days to Decision 235 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.