Cleared Traditional

K102259 - DENTAL COMPUTED TOMOGRAPHY X-RAY SYSTEM

K102259 is an FDA 510(k) clearance for DENTAL COMPUTED TOMOGRAPHY X-RAY SYSTEM, manufactured by VATECH Co., Ltd.. The device is a Class 2 Radiology device with product code JAK cleared through the Traditional 510(k) pathway after a 192-day FDA review.

K102259 · VATECH Co., Ltd. · Radiology device
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Feb 2011
Decision
192d
Days
Class 2
Risk

K102259 is an FDA 510(k) clearance for the DENTAL COMPUTED TOMOGRAPHY X-RAY SYSTEM. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by VATECH Co., Ltd. (Secaucus, US). The FDA issued a Cleared decision on February 18, 2011 after a review of 192 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

FDA 510(k) Submission Details - K102259

510(k) Number K102259 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 2010
Decision Date February 18, 2011
Days to Decision 192 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
85d slower than avg
Panel avg: 107d · This submission: 192d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JAK Device Classification - Class 2, Special Controls

Product Code JAK System, X-ray, Tomography, Computed
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1750
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 - JAK System, X-ray, Tomography, Computed

All 732
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K102259.
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