Cleared Traditional

K083640 - DIGITAL X-RAY IMAGING SYSTEM, MODEL: CXD-DR80D

K083640 is an FDA 510(k) clearance for DIGITAL X-RAY IMAGING SYSTEM, manufactured by Choong Wae Medical Corp.. The device is a Class 2 Radiology device with product code KPR cleared through the Traditional 510(k) pathway after a 202-day FDA review.

K083640 · Choong Wae Medical Corp. · Radiology device
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Optimized for regulatory review, auditing and printing
Jun 2009
Decision
202d
Days
Class 2
Risk

K083640 is an FDA 510(k) clearance for the DIGITAL X-RAY IMAGING SYSTEM, MODEL: CXD-DR80D. Classified as System, X-ray, Stationary (product code KPR), Class II - Special Controls.

Submitted by Choong Wae Medical Corp. (Echo, US). The FDA issued a Cleared decision on June 29, 2009 after a review of 202 days - an extended review cycle.

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. 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 Choong Wae Medical Corp. devices

FDA 510(k) Submission Details - K083640

510(k) Number K083640 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 2008
Decision Date June 29, 2009
Days to Decision 202 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
95d slower than avg
Panel avg: 107d · This submission: 202d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPR Device Classification - Class 2, Special Controls

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 220
Devices cleared under the same product code (KPR) and FDA review panel - the closest regulatory comparables to K083640.
DX-D 300
K103050 · Agfa Healthcare N.V. · Oct 2010
DIGITAL X-RAY IMAGING SYSTEM, MODEL DRC-1000
K092830 · VATECH Co., Ltd. · Jul 2010
DRX-EVOLUTION, MODEL VX3733-SYS
K091889 · Carestream Health, Inc. · Jul 2009
SEDECAL, MILLENNIUM PLUS
K090279 · Sedecal., Sa. · Mar 2009
SEDECAL X-PLUS LP PLUS DIGITAL DIAGNOSTIC X-RAY SYSTEMS
K090238 · Sedecal., Sa. · Feb 2009
DRAD30003/RADREX-I
K083503 · Toshiba America Medical Systems, In.C · Feb 2009