Cleared Special

PAX-FLEX3D, PHT-7000

K121412 · VATECH Co., Ltd. · Radiology
Jun 2012
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K121412 is an FDA 510(k) clearance for the PAX-FLEX3D, PHT-7000, 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 June 8, 2012, 28 days after receiving the submission on May 11, 2012. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1750.

Submission Details

510(k) Number K121412 FDA.gov
FDA Decision Cleared SESE
Date Received May 11, 2012
Decision Date June 08, 2012
Days to Decision 28 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.