Cleared Traditional

K082350 - PAX-500

K082350 is an FDA 510(k) clearance for PAX-500, 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 56-day FDA review.

K082350 · VATECH Co., Ltd. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2008
Decision
56d
Days
Class 2
Risk

K082350 is an FDA 510(k) clearance for the PAX-500. 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 October 10, 2008 after a review of 56 days - a notably fast clearance cycle.

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: 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 - K082350

510(k) Number K082350 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 2008
Decision Date October 10, 2008
Days to Decision 56 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
51d faster than avg
Panel avg: 107d · This submission: 56d
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 134
Devices cleared under the same product code (OAS) and FDA review panel - the closest regulatory comparables to K082350.
X-RAY, TOMOGRAPHY, COMPUTED, DENTAL
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VOLUMETRIC TOMOGRAPHY
K063773 · Instrumentarium Dental, Inc. · Jan 2007
NEWTOM 3G QR-DVT 9000
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