Cleared Traditional

Planmeca Viso

K230985 · Planmeca Oy · Radiology
Dec 2023
Decision
266d
Days
Class 2
Risk

About This 510(k) Submission

K230985 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 December 28, 2023, 266 days after receiving the submission on April 6, 2023. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1750.

Submission Details

510(k) Number K230985 FDA.gov
FDA Decision Cleared SESE
Date Received April 06, 2023
Decision Date December 28, 2023
Days to Decision 266 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.