Cleared Traditional

K090467 - DIGITAL X-RAY IMAGING SYSTEM, MODEL PAX-UNI3D

K090467 is an FDA 510(k) clearance for DIGITAL X-RAY IMAGING SYSTEM, manufactured by VATECH Co., Ltd.. The device is a Class 2 Radiology device with product code OAS cleared through the Traditional 510(k) pathway after a 319-day FDA review.

K090467 · VATECH Co., Ltd. · Radiology device
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Jan 2010
Decision
319d
Days
Class 2
Risk

K090467 is an FDA 510(k) clearance for the DIGITAL X-RAY IMAGING SYSTEM, MODEL PAX-UNI3D. Classified as X-ray, Tomography, Computed, Dental (product code OAS), Class II - Special Controls.

Submitted by VATECH Co., Ltd. (Houston, US). The FDA issued a Cleared decision on January 8, 2010 after a review of 319 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1750 - 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all VATECH Co., Ltd. devices

FDA 510(k) Submission Details - K090467

510(k) Number K090467 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 2009
Decision Date January 08, 2010
Days to Decision 319 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
212d slower than avg
Panel avg: 107d · This submission: 319d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OAS Device Classification - Class 2, Special Controls

Product Code OAS X-ray, Tomography, Computed, Dental
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1750
Definition Produce Cross-sectional Diagnostic X-ray Images Of The Intra-oral Tissue And Teeth.
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 - OAS X-ray, Tomography, Computed, Dental

All 128
Devices cleared under the same product code (OAS) and FDA review panel - the closest regulatory comparables to K090467.
NEWTOM 5G / NEWTOM 5G VERSION FP
K110260 · Qr S.R.L. · Apr 2011
COMPUTED TOMOGRAPHY X-RAY SYSTEM
K102196 · VATECH Co., Ltd. · Mar 2011
ORTHOPHOS XG 3D / CEPH
K103711 · Sirona Dental Systems GmbH · Mar 2011
PAX-500
K082350 · VATECH Co., Ltd. · Oct 2008
FINECUBE DENTAL CT
K063622 · The Yoshida Dental Mfg. Co., Ltd. · Feb 2007
VOLUMETRIC TOMOGRAPHY
K063773 · Instrumentarium Dental, Inc. · Jan 2007