Cleared Traditional

K213278 - Planmed Verity
(FDA 510(k) Clearance)

K213278 · Planmed OY · Radiology
Apr 2022
Decision
209d
Days
Class 2
Risk

K213278 is an FDA 510(k) clearance for the Planmed Verity. This device is classified as 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 April 28, 2022, 209 days after receiving the submission on October 1, 2021.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1750. Produce Cross-sectional Diagnostic X-ray Images Of The Intra-oral Tissue And Teeth..

Submission Details

510(k) Number K213278 FDA.gov
FDA Decision Cleared SESE
Date Received October 01, 2021
Decision Date April 28, 2022
Days to Decision 209 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.