Cleared Special

PAX-UNI3D, PHT-7500

K121400 · VATECH Co., Ltd. · Radiology
Aug 2012
Decision
110d
Days
Class 2
Risk

About This 510(k) Submission

K121400 is an FDA 510(k) clearance for the PAX-UNI3D, PHT-7500, a X-ray, Tomography, Computed, Dental (Class II — Special Controls, product code OAS), submitted by VATECH Co., Ltd. (Houston, US). The FDA issued a Cleared decision on August 28, 2012, 110 days after receiving the submission on May 10, 2012. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1750.

Submission Details

510(k) Number K121400 FDA.gov
FDA Decision Cleared SESE
Date Received May 10, 2012
Decision Date August 28, 2012
Days to Decision 110 days
Submission Type Special
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.