Data / Medical devices / South Korea / DRTECH Corporation
DRTECH Corporation: FDA-registered device maker in Seongnam-si Gyeonggi, South Korea, 24 510(k) clearances
DRTECH Corporation is registered with the FDA (registration 3005172103) in Seongnam-si Gyeonggi, South Korea. It lists 10 device types. The FDA files 24 510(k) clearances under its listings, the newest dated September 8, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005172103
- Address
- Suite No.1, 2 Floor / Suite No.2, 3 Floor, 29, Dunchon-daero 541beon-gil JUNGWON-GU, Seongnam-si Gyeonggi, South Korea, 13216
- Owner or operator
- DRTECH CORPORATION (9073399)
- Roles
- Manufacturer
- First device listed
- December 5, 2011
- Registered through
- 2026
- Brand names listed
- DBS-57M, EConsole1, EConsole2, EVS 2430GW, EVS 2430W, EVS 3643, EVS 3643G, EVS 3643A, EVS 3643AG, EVS 4343A, EVS 4343AG, EVS 3643W, EVS 3643WG, EVS 3643WP, EVS 4343W, EVS 4343WG, EVS 4343WP, EVS 4343, EVS 4343G and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Full Field Digital, System, X-Ray, Mammographic | MUE | 2 | Manufacturer | accessdata.fda.gov |
| Generator, High-Voltage, X-Ray, Diagnostic | IZO | 1 | Manufacturer | accessdata.fda.gov |
| Holder, Radiographic Cassette, Wall-Mounted | IXY | 1 | Manufacturer | accessdata.fda.gov |
| Image-Intensified Fluoroscopic X-Ray System, Mobile | OXO | 2 | Manufacturer | accessdata.fda.gov |
| Interventional Fluoroscopic X-Ray System | OWB | 2 | Manufacturer | accessdata.fda.gov |
| Solid State X-Ray Imager (Flat Panel/Digital Imager) | MQB | 2 | Manufacturer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Manufacturer | accessdata.fda.gov |
| System, X-Ray, Fluoroscopic, Image-Intensified | JAA | 2 | Manufacturer | accessdata.fda.gov |
| System, X-Ray, Stationary | KPR | 2 | Manufacturer | accessdata.fda.gov |
| Unit, X-Ray, Extraoral With Timer | EHD | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 8, 2026 | K260227 | EXSYS DEXi (EXSYS DEXi-S40S); EXSYS DEXi (EXSYS DEXi-S40P); EXSYS DEXi (EXSYS DEXi-S40T); EXSYS DEXi (EXSYS DEXi-S50H | KPR | Substantially Equivalent | DRTECH Corporation | accessdata.fda.gov |
| August 19, 2026 | K261413 | EXTRON 3;EXTRON 6 | OWB | Substantially Equivalent | DRTECH Corporation | accessdata.fda.gov |
| June 10, 2025 | K250010 | EXTRON 3; EXTRON 5; EXTRON 7 | OWB | Substantially Equivalent | DRTECH Corporation | accessdata.fda.gov |
| March 20, 2025 | K242770 | EXPD 114; EXPD 114G; EXPD 114P; EXPD 114PG | MQB | Substantially Equivalent | DRTECH Corporation | accessdata.fda.gov |
| March 19, 2025 | K243443 | EXPD 4343N1; EXPD 4343N; EXPD 4343U1; EXPD 4343NU; EXPD 4343NP; EXPD 3643N1; EXPD 3643N; EXPD 3643U1; EXPD 3643NU; EXPD 3643NP | MQB | Substantially Equivalent | DRTECH Corporation | accessdata.fda.gov |
| November 1, 2024 | K242591 | XERO-alpha | EHD | Substantially Equivalent | DRTECH Corporation | accessdata.fda.gov |
| October 23, 2024 | K242847 | 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); | KPR | Substantially Equivalent | DRTECH Corporation | accessdata.fda.gov |
| September 23, 2024 | K240243 | EConsole2 | LLZ | Substantially Equivalent | DRTECH Corporation | accessdata.fda.gov |
| February 13, 2024 | K232082 | EXPD 4343S | MQB | Substantially Equivalent | DRTECH Corporation | accessdata.fda.gov |
| November 16, 2023 | K232753 | EXPD 4343D; EXPD 3643D | MQB | Substantially Equivalent | DRTECH Corporation | accessdata.fda.gov |
| October 18, 2023 | K231225 | EConsole1 | LLZ | Substantially Equivalent | DRTECH Corporation | accessdata.fda.gov |
| August 1, 2023 | K231959 | EXPD 4357; EXPD 4357P | MQB | Substantially Equivalent | DRTECH Corporation | accessdata.fda.gov |
| January 26, 2023 | K220073 | RMF-2000 | MUE | Substantially Equivalent | DRTECH Corporation | accessdata.fda.gov |
| November 18, 2022 | K223124 | EXPD 86P, EXPD 86PG, EXPD 129P, EXPD 129PG | MQB | Substantially Equivalent | DRTECH Corporation | accessdata.fda.gov |
| November 22, 2019 | K193031 | EXPD 4343P, EXPD 3643P | MQB | Substantially Equivalent | DRTECH Corporation | accessdata.fda.gov |
| November 22, 2019 | K193017 | EVS 4343W / EVS 4343WG / EVS 4343WP / EVS 3643W / EVS 3643WG / EVS 3643WP | MQB | Substantially Equivalent | DRTECH Corporation | accessdata.fda.gov |
| October 3, 2019 | K192400 | EVS 4343A, EVS 4343AG, EVS 3643A, EVS 3643AG | MQB | Substantially Equivalent | DRTECH Corporation | accessdata.fda.gov |
| May 15, 2017 | K171137 | EVS 2430W, EVS 2430GW | MQB | Substantially Equivalent | DRTECH Corporation | accessdata.fda.gov |
| April 27, 2017 | K170930 | RSM 2430C | MUE | Substantially Equivalent | DRTECH Corporation | accessdata.fda.gov |
| February 23, 2017 | K162670 | RSM 1824C with RConsole1 | MUE | Substantially Equivalent | DRTECH Corporation | accessdata.fda.gov |
| December 21, 2016 | K162555 | EVS 4343, EVS 4343G | MQB | Substantially Equivalent | DRTECH Corporation | accessdata.fda.gov |
| December 2, 2016 | K162552 | EVS 3643, EVS 3643G | MQB | Substantially Equivalent | DRTECH Corporation | accessdata.fda.gov |
| December 14, 2015 | K152172 | Econsole1 | LLZ | Substantially Equivalent | DRTECH Corporation | accessdata.fda.gov |
| October 4, 2011 | K111583 | FLAATZ 560 | MQB | Substantially Equivalent | Drtech Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of Image-Intensified Fluoroscopic X-Ray System, Mobile
- All makers of System, X-Ray, Fluoroscopic, Image-Intensified
- All makers of Interventional Fluoroscopic X-Ray System
- All makers of Solid State X-Ray Imager (Flat Panel/Digital Imager)
- All makers of System, Image Processing, Radiological
- All makers of Unit, X-Ray, Extraoral With Timer
Updated September 8, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.