Cleared Special

K162555 - EVS 4343

K162555 is an FDA 510(k) clearance for EVS 4343, 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 99-day FDA review.

K162555 · DRTECH Corporation · Radiology device
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Dec 2016
Decision
99d
Days
Class 2
Risk

K162555 is an FDA 510(k) clearance for the EVS 4343, EVS 4343G. 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 December 21, 2016 after a review of 99 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 - K162555

510(k) Number K162555 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 2016
Decision Date December 21, 2016
Days to Decision 99 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
8d faster than avg
Panel avg: 107d · This submission: 99d
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 K162555.
1717SCC_127um and 1717SCC_140um
K171420 · Rayence Co., Ltd. · Jun 2017
EVS 2430W, EVS 2430GW
K171137 · DRTECH Corporation · May 2017
DIGITAL RADIOGRAPHY CXDI-710C WIRELESS, DIGITAL RADIOGRAPHY CXDI-810C WIRELESS
K170332 · Canon, Inc. · Mar 2017
EVS 3643, EVS 3643G
K162552 · DRTECH Corporation · Dec 2016
1012WCC, 1012WGC
K162518 · Rayence Co., Ltd. · Oct 2016
1717WCC / 1717WGC
K162519 · Rayence Co., Ltd. · Oct 2016