Cleared Traditional

K092830 - DIGITAL X-RAY IMAGING SYSTEM

K092830 is the FDA 510(k) clearance for DIGITAL X-RAY IMAGING SYSTEM by VATECH Co., Ltd.. It is a Class 2 Radiology device (product code KPR) cleared through the Traditional 510(k) pathway after a 310-day FDA review.

K092830 · VATECH Co., Ltd. · Radiology device
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Jul 2010
Decision
310d
Days
Class 2
Risk

K092830 is an FDA 510(k) clearance for the DIGITAL X-RAY IMAGING SYSTEM, MODEL DRC-1000. Classified as System, X-ray, Stationary (product code KPR), Class II - Special Controls.

Submitted by VATECH Co., Ltd. (Houston, US). The FDA issued a Cleared decision on July 21, 2010 after a review of 310 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1680 - 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. Elevated predicate reliance profile. 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 K092830 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 2009
Decision Date July 21, 2010
Days to Decision 310 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
203d slower than avg
Panel avg: 107d · This submission: 310d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KPR System, X-ray, Stationary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1680
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 - KPR System, X-ray, Stationary

All 171
Devices cleared under the same product code (KPR) and FDA review panel - the closest regulatory comparables to K092830.
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DRX-EVOLUTION, MODEL VX3733-SYS
K091889 · Carestream Health, Inc. · Jul 2009
DRAD30003/RADREX-I
K083503 · Toshiba America Medical Systems, In.C · Feb 2009
YSIO
K081722 · Siemens Medical Solutions USA, Inc. · Aug 2008