Cleared Traditional

Planmeca Viso

K181576 · Planmeca Oy · Radiology
Sep 2018
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K181576 is an FDA 510(k) clearance for the Planmeca Viso, a X-ray, Tomography, Computed, Dental (Class II — Special Controls, product code OAS), submitted by Planmeca Oy (Helsinki, FI). The FDA issued a Cleared decision on September 13, 2018, 90 days after receiving the submission on June 15, 2018. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1750.

Submission Details

510(k) Number K181576 FDA.gov
FDA Decision Cleared SESE
Date Received June 15, 2018
Decision Date September 13, 2018
Days to Decision 90 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.