Cleared Special

K193017 - EVS 4343W / EVS 4343WG / EVS 4343WP / EVS 3643W / EVS 3643WG / EVS 3643WP

K193017 is an FDA 510(k) clearance for EVS 4343W / EVS 4343WG / EVS 4343WP / E..., 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 24-day FDA review.

K193017 · DRTECH Corporation · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2019
Decision
24d
Days
Class 2
Risk

K193017 is an FDA 510(k) clearance for the EVS 4343W / EVS 4343WG / EVS 4343WP / EVS 3643W / EVS 3643WG / EVS 3643WP. Classified as Solid State X-ray Imager (flat Panel/digital Imager) (product code MQB), Class II - Special Controls.

Submitted by DRTECH Corporation (Jungwon-Gu, Seongam-Si, KR). The FDA issued a Cleared decision on November 22, 2019 after a review of 24 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.

FDA 510(k) Submission Details - K193017

510(k) Number K193017 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 2019
Decision Date November 22, 2019
Days to Decision 24 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
83d faster than avg
Panel avg: 107d · This submission: 24d
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 423
Devices cleared under the same product code (MQB) and FDA review panel - the closest regulatory comparables to K193017.
HAD1717MC
K200018 · H&Abyz · Jan 2020
Nexus DR Digital X-Ray Imaging System (with vSharp)
K193238 · Varex Imaging Corporation · Dec 2019
CareView 1800Le
K193173 · Careray Digital Medical System Co., Ltd. · Dec 2019
EXPD 4343P, EXPD 3643P
K193031 · DRTECH Corporation · Nov 2019
FDR D-EVO III flat panel detector system
K192932 · Fujifilm Corporation · Nov 2019
DIGITAL RADIOGRAPHY CXDI-702C Wireless, DIGITAL RADIOGRAPHY CXDI-402C Wireless
K192632 · Canon, Inc. · Nov 2019
K193017 · EVS 4343W / EVS 4343WG / EVS 4343WP / EVS 3643W / EVS 3643WG / EVS 3643WP
Download PDF FDA Summary DRTECH Corporation