Medical Device Manufacturer · KR , Seongam-Si

DRTECH Corporation - FDA 510(k) Cleared Devices

25 submissions · 25 cleared · Since 2015
25
Total
25
Cleared
0
Denied

DRTECH Corporation has 25 FDA 510(k) cleared radiology devices. Based in Seongam-Si, KR.

Latest FDA clearance: Jun 2025. Active since 2015.

Browse the complete list of FDA 510(k) cleared radiology devices from this manufacturer. Filter by specialty or product code using the sidebar.

FDA 510(k) Regulatory Record - DRTECH Corporation
25 devices
1-25 of 25
Cleared Jun 10, 2025
EXTRON 3
K250010 · OWB
Radiology · 159d
Cleared Mar 20, 2025
EXPD 114
K242770 · MQB
Radiology · 188d
Cleared Mar 19, 2025
EXPD 4343N1
K243443 · MQB
Radiology · 133d
Cleared Nov 01, 2024
XERO-alpha
K242591 · EHD
Radiology · 63d
Cleared Oct 23, 2024
EXSYS DEXi (EXSYS DEXi-D401S-FRM)
K242847 · KPR
Radiology · 33d
Cleared Sep 23, 2024
EConsole2
K240243 · LLZ
Radiology · 237d
Cleared Jul 26, 2024
EXSYS DEXi (EXSYS DEXi-D401S-FRM)
K233530 · KPR
Radiology · 267d
Cleared Feb 13, 2024
EXPD 4343S
K232082 · MQB
Radiology · 215d
Cleared Nov 16, 2023
EXPD 4343D
K232753 · MQB
Radiology · 69d
Cleared Oct 18, 2023
EConsole1
K231225 · LLZ
Radiology · 173d
Cleared Aug 17, 2023
EXTRON 5
K230871 · OWB
Radiology · 140d
Cleared Aug 01, 2023
EXPD 4357
K231959 · MQB
Radiology · 29d
Cleared Jan 26, 2023
RMF-2000
K220073 · MUE
Radiology · 381d
Cleared Nov 18, 2022
EXPD 86P, EXPD 86PG, EXPD 129P, EXPD 129PG
K223124 · MQB
Radiology · 46d
Cleared Nov 22, 2019
EVS 4343W / EVS 4343WG / EVS 4343WP / EVS 3643W / EVS 3643WG / EVS 3643WP
K193017 · MQB
Radiology · 24d
Cleared Nov 22, 2019
EXPD 4343P, EXPD 3643P
K193031 · MQB
Radiology · 23d
Cleared Oct 03, 2019
EVS 4343A, EVS 4343AG, EVS 3643A, EVS 3643AG
K192400 · MQB
Radiology · 30d
Cleared May 15, 2017
EVS 2430W, EVS 2430GW
K171137 · MQB
Radiology · 28d
Cleared Apr 27, 2017
RSM 2430C
K170930 · MUE
Radiology · 29d
Cleared Feb 23, 2017
RSM 1824C with RConsole1
K162670 · MUE
Radiology · 150d
Cleared Dec 21, 2016
EVS 4343, EVS 4343G
K162555 · MQB
Radiology · 99d
Cleared Dec 02, 2016
EVS 3643, EVS 3643G
K162552 · MQB
Radiology · 80d
Cleared Dec 14, 2015
Econsole1
K152172 · LLZ
Radiology · 132d
Cleared Oct 21, 2015
EVS 3643
K151942 · MQB
Radiology · 99d
Cleared Jan 15, 2015
EVS 4343
K142475 · MQB
Radiology · 134d
Filters
All25 Radiology 25