Cleared Traditional

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

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

K092103 · VATECH Co., Ltd. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K092103

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.

EHD Device Classification - Class 2, Special Controls

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 190
Devices cleared under the same product code (EHD) and FDA review panel - the closest regulatory comparables to K092103.
MINXRAY, MODEL: BPD60
K091255 · Minxray, Inc. · May 2010
BELRAY II
K093240 · Takara Belmont Corp. · Mar 2010
PORTABLE X-RAY SYSTEM, MODEL HAND-RAY
K092772 · Hanjin Digi-X Co., Ltd. · Jan 2010
PLANMECA PROSENSOR
K091197 · Planmeca Oy · Jul 2009
ROOGRAPH EVO, MODEL 9307XY11Z1, ROTOGRAPH EVO D, MODEL 9307XY1191
K090749 · Villa Sistemi Medicali S.P.A. · May 2009
PORTABLE X-RAY SYSTEM, MODEL DXR -1
K082875 · Exaro Co., Ltd. · Feb 2009
K092103 · DENTAL EXTRAORAL SOURCE X-RAY SYSTEM (ESX)
Download PDF FDA Summary VATECH Co., Ltd.