Cleared Traditional

K160882 - PaX-i3D Green Premium (Model: PCT-90LH)

K160882 is the FDA 510(k) clearance for PaX-i3D Green Premium (Model: PCT-90LH) by VATECH Co., Ltd.. It is a Class 2 Radiology device (product code OAS) cleared through the Traditional 510(k) pathway after a 211-day FDA review.

K160882 · VATECH Co., Ltd. · Radiology device
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Oct 2016
Decision
211d
Days
Class 2
Risk

K160882 is an FDA 510(k) clearance for the PaX-i3D Green Premium (Model: PCT-90LH). Classified as X-ray, Tomography, Computed, Dental (product code OAS), Class II - Special Controls.

Submitted by VATECH Co., Ltd. (Hwaseong-Si, KR). The FDA issued a Cleared decision on October 28, 2016 after a review of 211 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. 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

Submission Details

510(k) Number K160882 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 2016
Decision Date October 28, 2016
Days to Decision 211 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
104d slower than avg
Panel avg: 107d · This submission: 211d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Consultant

Mtechgroup
Dave Kim

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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