Medical Device Manufacturer · KR , Seongam-Si

DRTECH Corporation

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

DRTECH Corporation — FDA 510(k) Submissions

DRTECH Corporation has submitted 25 FDA 510(k) premarket notifications since 2015, of which 25 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Solid State X-ray Imager (flat Panel/digital Imager), System, Image Processing, Radiological, Full Field Digital, System, X-ray, Mammographic, Interventional Fluoroscopic X-ray System, System, X-ray, Stationary . Use the specialty filter in the sidebar to narrow results.

25 devices
1–25 of 25
EXTRON 3; EXTRON 5; EXTRON 7
K250010 · OWB Interventional... · Radiology
Jun 2025 159d
EXPD 114; EXPD 114G; EXPD 114P; EXPD 114PG
K242770 · MQB Solid State X-ray Imager... · Radiology
Mar 2025 188d
EXPD 4343N1; EXPD 4343N; EXPD 4343U1; EXPD 4343NU; EXPD 4343NP; EXPD 3643N1; EXPD 3643N; EXPD 3643U1; EXPD 3643NU; EXPD 3643NP
K243443 · MQB Solid State X-ray Imager... · Radiology
Mar 2025 133d
XERO-alpha
K242591 · EHD Unit, X-ray, Extraoral... · Radiology
Nov 2024 63d
EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A401S-FRM); EXSYS DEXi (EXSYS DEXi-D402S-FRM); EXSYS DEXi (EXSYS DEXi-A402S-FRM); EXSYS DEXi (EXSYS DEXi-D401P-FRM); EXSYS DEXi (EXSYS DEXi-A401P-FRM); EXSYS DEXi (EXSYS DEXi-D402P-FRM); EXSYS DEXi (EXSYS DEXi-A402P-FRM); EXSYS DEXi (EXSYS DEXi-D503T-FRM); EXSYS DEXi (EXSYS DEXi-A503T-FRM); EXSYS DEXi (EXSYS DEXi-D401S-FRA); EXSYS DEXi (EXSYS DEXi-D402S-FRA); EXSYS DEXi (EXSYS DEXi-D401P-FRA); EXSYS DEXi (EXSYS DEXi-D402P-FRA);
K242847 · KPR System, X-ray, Stationary · Radiology
Oct 2024 33d
EConsole2
K240243 · LLZ System, Image Processing,... · Radiology
Sep 2024 237d
EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A401S-FRM); EXSYS DEXi (EXSYS DEXi-D402S-FRM); EXSYS DEXi (EXSYS DEXi-A402S-FRM); EXSYS DEXi (EXSYS DEXi-D401P-FRM); EXSYS DEXi (EXSYS DEXi-A401P-FRM); EXSYS DEXi (EXSYS DEXi-D402P-FRM); EXSYS DEXi (EXSYS DEXi-A402P-FRM); EXSYS DEXi (EXSYS DEXi-D503T-FRM); EXSYS DEXi (EXSYS DEXi-A503T-FRM)
K233530 · KPR System, X-ray, Stationary · Radiology
Jul 2024 267d
EXPD 4343S
K232082 · MQB Solid State X-ray Imager... · Radiology
Feb 2024 215d
EXPD 4343D; EXPD 3643D
K232753 · MQB Solid State X-ray Imager... · Radiology
Nov 2023 69d
EConsole1
K231225 · LLZ System, Image Processing,... · Radiology
Oct 2023 173d
EXTRON 5; EXTRON 7
K230871 · OWB Interventional... · Radiology
Aug 2023 140d
EXPD 4357; EXPD 4357P
K231959 · MQB Solid State X-ray Imager... · Radiology
Aug 2023 29d
RMF-2000
K220073 · MUE Full Field Digital,... · Radiology
Jan 2023 381d
EXPD 86P, EXPD 86PG, EXPD 129P, EXPD 129PG
K223124 · MQB Solid State X-ray Imager... · Radiology
Nov 2022 46d
EVS 4343W / EVS 4343WG / EVS 4343WP / EVS 3643W / EVS 3643WG / EVS 3643WP
K193017 · MQB Solid State X-ray Imager... · Radiology
Nov 2019 24d
EXPD 4343P, EXPD 3643P
K193031 · MQB Solid State X-ray Imager... · Radiology
Nov 2019 23d
EVS 4343A, EVS 4343AG, EVS 3643A, EVS 3643AG
K192400 · MQB Solid State X-ray Imager... · Radiology
Oct 2019 30d
EVS 2430W, EVS 2430GW
K171137 · MQB Solid State X-ray Imager... · Radiology
May 2017 28d
RSM 2430C
K170930 · MUE Full Field Digital,... · Radiology
Apr 2017 29d
RSM 1824C with RConsole1
K162670 · MUE Full Field Digital,... · Radiology
Feb 2017 150d
EVS 4343, EVS 4343G
K162555 · MQB Solid State X-ray Imager... · Radiology
Dec 2016 99d
EVS 3643, EVS 3643G
K162552 · MQB Solid State X-ray Imager... · Radiology
Dec 2016 80d
Econsole1
K152172 · LLZ System, Image Processing,... · Radiology
Dec 2015 132d
EVS 3643
K151942 · MQB Solid State X-ray Imager... · Radiology
Oct 2015 99d
EVS 4343
K142475 · MQB Solid State X-ray Imager... · Radiology
Jan 2015 134d
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