Cleared Traditional

K092103 - DENTAL EXTRAORAL SOURCE X-RAY SYSTEM (ESX)

K092103 is the FDA 510(k) clearance for DENTAL EXTRAORAL SOURCE X-RAY SYSTEM (ESX) by VATECH Co., Ltd.. It is a Class 2 Radiology device (product code EHD) cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K092103 · VATECH Co., Ltd. · Radiology device
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Oct 2009
Decision
87d
Days
Class 2
Risk

K092103 is an FDA 510(k) clearance for the DENTAL EXTRAORAL SOURCE X-RAY SYSTEM (ESX). Classified as Unit, X-ray, Extraoral With Timer (product code EHD), Class II - Special Controls.

Submitted by VATECH Co., Ltd. (Houston, US). The FDA issued a Cleared decision on October 9, 2009 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 872.1800 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all VATECH Co., Ltd. devices

Submission Details

510(k) Number K092103 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 2009
Decision Date October 09, 2009
Days to Decision 87 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 107d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EHD Unit, X-ray, Extraoral With Timer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.1800
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - EHD Unit, X-ray, Extraoral With Timer

All 65
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