Cleared Traditional

K113672 - PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY...

K113672 is the FDA 510(k) clearance for PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY... by VATECH Co., Ltd.. It is a Class 2 Radiology device (product code MUH) cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K113672 · VATECH Co., Ltd. · Radiology device
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Mar 2012
Decision
105d
Days
Class 2
Risk

K113672 is an FDA 510(k) clearance for the PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM. Classified as System, X-ray, Extraoral Source, Digital (product code MUH), Class II - Special Controls.

Submitted by VATECH Co., Ltd. (Houston, US). The FDA issued a Cleared decision on March 27, 2012 after a review of 105 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 872.1800 - 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 K113672 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 2011
Decision Date March 27, 2012
Days to Decision 105 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
2d faster than avg
Panel avg: 107d · This submission: 105d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MUH System, X-ray, Extraoral Source, Digital
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.1800
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 - MUH System, X-ray, Extraoral Source, Digital

All 73
Devices cleared under the same product code (MUH) and FDA review panel - the closest regulatory comparables to K113672.
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K102124 · VATECH Co., Ltd. · Oct 2010