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

FDA 510(k) cleared devices by DRTECH Corporation Radiology

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
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