Cleared Traditional

K170066 - Green16/Green18 (Model: PHT-65LHS) (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K170066 · VATECH Co., Ltd. · Radiology device
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Jun 2017
Decision
158d
Days
Class 2
Risk

K170066 is an FDA 510(k) clearance for the Green16/Green18 (Model: PHT-65LHS). 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 June 16, 2017 after a review of 158 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 K170066 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 2017
Decision Date June 16, 2017
Days to Decision 158 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d slower than avg
Panel avg: 107d · This submission: 158d
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 Peers - OAS X-ray, Tomography, Computed, Dental

All 129
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