Cleared Special

K171137 - EVS 2430W

K171137 is an FDA 510(k) clearance for EVS 2430W, manufactured by DRTECH Corporation. The device is a Class 2 Radiology device with product code MQB cleared through the Special 510(k) pathway after a 28-day FDA review.

K171137 · DRTECH Corporation · Radiology device
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May 2017
Decision
28d
Days
Class 2
Risk

K171137 is an FDA 510(k) clearance for the EVS 2430W, EVS 2430GW. Classified as Solid State X-ray Imager (flat Panel/digital Imager) (product code MQB), Class II - Special Controls.

Submitted by DRTECH Corporation (Seongnam-Si, KR). The FDA issued a Cleared decision on May 15, 2017 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1680 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all DRTECH Corporation devices

FDA 510(k) Submission Details - K171137

510(k) Number K171137 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 2017
Decision Date May 15, 2017
Days to Decision 28 days
Submission Type Special
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
79d faster than avg
Panel avg: 107d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

MQB Device Classification - Class 2, Special Controls

Product Code MQB Solid State X-ray Imager (flat Panel/digital Imager)
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 - MQB Solid State X-ray Imager (flat Panel/digital Imager)

All 259
Devices cleared under the same product code (MQB) and FDA review panel - the closest regulatory comparables to K171137.
1417WCC_127um and1417WCC_140um
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1717SGC_127um and 1717SGC_140um
K171419 · Rayence Co., Ltd. · Jun 2017
1717SCC_127um and 1717SCC_140um
K171420 · Rayence Co., Ltd. · Jun 2017
DIGITAL RADIOGRAPHY CXDI-710C WIRELESS, DIGITAL RADIOGRAPHY CXDI-810C WIRELESS
K170332 · Canon, Inc. · Mar 2017
EVS 4343, EVS 4343G
K162555 · DRTECH Corporation · Dec 2016
EVS 3643, EVS 3643G
K162552 · DRTECH Corporation · Dec 2016