Cleared Special

PHT-6500, PHT-60CFO

K130432 · VATECH Co., Ltd. · Radiology
May 2013
Decision
99d
Days
Class 2
Risk

About This 510(k) Submission

K130432 is an FDA 510(k) clearance for the PHT-6500, PHT-60CFO, 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 May 31, 2013, 99 days after receiving the submission on February 21, 2013. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1750.

Submission Details

510(k) Number K130432 FDA.gov
FDA Decision Cleared SESE
Date Received February 21, 2013
Decision Date May 31, 2013
Days to Decision 99 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.