DRTECH Corporation
Seongnam-si Gyeonggi, KR
DRTECH CORPORATION appears in FDA device records in Seongnam-si Gyeonggi, KR. FDA records list 31 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 31 510(k) clearances for DRTECH Corporation between 2008 and 2025. The busiest year on record is 2023, with 5. The most recent is 2025, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2008 | 1 |
| 2009 | 1 |
| 2011 | 3 |
| 2014 | 1 |
| 2015 | 3 |
| 2016 | 2 |
| 2017 | 3 |
| 2019 | 3 |
| 2022 | 1 |
| 2023 | 5 |
| 2024 | 5 |
| 2025 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K250010 | EXTRON 3; EXTRON 5; EXTRON 7 | OWB | Substantially Equivalent | |
| K242770 | EXPD 114; EXPD 114G; EXPD 114P; EXPD 114PG | MQB | Substantially Equivalent | |
| K243443 | EXPD 4343N1; EXPD 4343N; EXPD 4343U1; EXPD 4343NU; EXPD 4343NP; EXPD 3643N1; EXPD 3643N; EXPD 3643U1; EXPD 3643NU; EXPD 3643NP | MQB | Substantially Equivalent | |
| K242591 | XERO-alpha | EHD | Substantially Equivalent | |
| 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 | |
| K240243 | EConsole2 | LLZ | Substantially Equivalent | |
| K233530 | 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) | KPR | Substantially Equivalent | |
| K232082 | EXPD 4343S | MQB | Substantially Equivalent | |
| K232753 | EXPD 4343D; EXPD 3643D | MQB | Substantially Equivalent | |
| K231225 | EConsole1 | LLZ | Substantially Equivalent | |
| K230871 | EXTRON 5; EXTRON 7 | OWB | Substantially Equivalent | |
| K231959 | EXPD 4357; EXPD 4357P | MQB | Substantially Equivalent | |
| K220073 | RMF-2000 | MUE | Substantially Equivalent | |
| K223124 | EXPD 86P, EXPD 86PG, EXPD 129P, EXPD 129PG | MQB | Substantially Equivalent | |
| K193031 | EXPD 4343P, EXPD 3643P | MQB | Substantially Equivalent | |
| K193017 | EVS 4343W / EVS 4343WG / EVS 4343WP / EVS 3643W / EVS 3643WG / EVS 3643WP | MQB | Substantially Equivalent | |
| K192400 | EVS 4343A, EVS 4343AG, EVS 3643A, EVS 3643AG | MQB | Substantially Equivalent | |
| K171137 | EVS 2430W, EVS 2430GW | MQB | Substantially Equivalent | |
| K170930 | RSM 2430C | MUE | Substantially Equivalent | |
| K162670 | RSM 1824C with RConsole1 | MUE | Substantially Equivalent | |
| K162555 | EVS 4343, EVS 4343G | MQB | Substantially Equivalent | |
| K162552 | EVS 3643, EVS 3643G | MQB | Substantially Equivalent | |
| K152172 | Econsole1 | LLZ | Substantially Equivalent | |
| K151942 | EVS 3643 | MQB | Substantially Equivalent | |
| K142475 | EVS 4343 | MQB | Substantially Equivalent | |
| K132842 | FLAATZ 600 SERIES (FLAATZ 600/601) | MQB | Substantially Equivalent | |
| K111655 | FLAATZ 760 | KPR | Substantially Equivalent | |
| K111583 | FLAATZ 560 | MQB | Substantially Equivalent | |
| K102474 | FLAATZ 750E | MQB | Substantially Equivalent | |
| K091747 | FLAATZ 500 | KPR | Substantially Equivalent | |
| K080064 | FLAATZ 750 | MQB | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3024891354 | 3024891354 | DRTECH CORPORATION | 5F, Seongnam-si Gyeonggi 13212 KR | 2026 | |
| 3005172103 | 3005172103 | DRTECH Corporation | Suite No.1, 2 Floor / Suite No.2, 3 Floor, 29, Dunchon-daero 541beon-gil, Seongnam-si Gyeonggi 13216 KR | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- MYNAnalyzer, Medical Image
- MUEFull Field Digital, System, X-Ray, Mammographic
- IZOGenerator, High-Voltage, X-Ray, Diagnostic
- IXYHolder, Radiographic Cassette, Wall-Mounted
- OXOImage-Intensified Fluoroscopic X-Ray System, Mobile
- OWBInterventional Fluoroscopic X-Ray System
- MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)
- LLZSystem, Image Processing, Radiological
- JAASystem, X-Ray, Fluoroscopic, Image-Intensified
- IZLSystem, X-Ray, Mobile
- KPRSystem, X-Ray, Stationary
- EHDUnit, X-Ray, Extraoral With Timer
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain