FDA Registration
Active
🇰🇷 South Korea
DRTECH Corporation
Reg #: 3005172103
·
FEI: 3005172103
·
Expires 2026
Products
10
Proprietary Names
59
Establishment Types
1
Classifications
10
Registration Details
- Registration Name
- DRTECH Corporation
- Registration Number
- 3005172103
- FEI Number
- 3005172103
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Suite No.1, 2 Floor / Suite No.2, 3 Floor, 29, Dunchon-daero 541beon-gil, JUNGWON-GU
- City
- Seongnam-si Gyeonggi
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K162670
Owner / Operator
- Firm Name
- DRTECH CORPORATION
- Operator Number
- 9073399
- Address
- Suite No.2, 3 Floor, 29, Dunchon-daero541beon-gil, Jungwon-gu
- City
- Seongnam-si
- State
- Gyeonggi
- Postal Code
- 13216
- Country
- KR
- Correspondent
- SEONGHYUN - AHN
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2017-08-03 |
| Full Field Digital, System, X-Ray, Mammographic | MUE | Class 2 | Radiology | No | 2017-08-03 |
| Generator, High-Voltage, X-Ray, Diagnostic | IZO | Class 1 | Radiology | No | 2025-05-08 |
| System, X-Ray, Stationary | KPR | Class 2 | Radiology | No | 2024-11-07 |
| Solid State X-Ray Imager (Flat Panel/Digital Imager) | MQB | Class 2 | Radiology | No | 2017-08-03 |
| Holder, Radiographic Cassette, Wall-Mounted | IXY | Class 1 | Radiology | No | 2022-11-21 |
| Unit, X-Ray, Extraoral With Timer | EHD | Class 2 | Dental | No | 2024-12-01 |
| Image-Intensified Fluoroscopic X-Ray System, Mobile | OXO | Class 2 | Radiology | No | 2025-06-13 |
| System, X-Ray, Fluoroscopic, Image-Intensified | JAA | Class 2 | Radiology | No | 2025-06-13 |
| Interventional Fluoroscopic X-Ray System | OWB | Class 2 | Radiology | No | 2025-06-13 |
Proprietary Names
RSM 1824C with RConsole1
NexGen 900 Series; NexGen 940 Series; NexGen 950 Series; NexGen 960 Series
EXSYS DEXi (EXSYS DEXi-A401S-FRM)
EXSYS DEXi (EXSYS DEXi-A402P-FRM)
EXSYS DEXi (EXSYS DEXi-A503T-FRM)
EXSYS DEXi (EXSYS DEXi-D401S-FRM)
EXSYS DEXi (EXSYS DEXi-D402S-FRM)
EXSYS DEXi (EXSYS DEXi-A401P-FRM)
EXSYS DEXi (EXSYS DEXi-D401S-FRA)
EXSYS DEXi (EXSYS DEXi-D503T-FRA)
EXSYS DEXi (EXSYS DEXi-D402S-FRA)
EXSYS DEXi (EXSYS DEXi-A402S-FRM)
EXSYS DEXi (EXSYS DEXi-D402P-FRM)
EXSYS DEXi (EXSYS DEXi-D503T-FRM)
EXSYS DEXi (EXSYS DEXi-D401P-FRA)
EXSYS DEXi (EXSYS DEXi-D402P-FRA)
EXSYS DEXi (EXSYS DEXi-D401P-FRM)
EVS 2430GW, EVS 2430W
EConsole2
EXPD 3643D
EXPD 4343D
FLAATZ 560
RMF-2000
EConsole1
EVS 3643W, EVS 3643WG, EVS 3643WP, EVS 4343W, EVS 4343WG, EVS 4343WP
EXPD 129P, EXPD 129PG, EXPD 86P, EXPD 86PG
LLD 129 Basic
LLD 129 Compact
LLD 129 with rotation
LLD 129 without rotation
DBS-57M
LLD 129 Samsung
LLD 86 Basic
EXPD 4343U1
EXPD 3643NU
EXPD 4343N1
EXPD 3643N1
EXPD 4343N
EXPD 4343NU
EXPD 3643N
EXPD 3643NP
EXPD 4343NP
EXPD 3643U1
EVS 3643, EVS 3643G
EXPD 3643P, EXPD 4343P
XERO ?
EVS 4343, EVS 4343G
EXPD 4343S
Econsole1
EXTRON 3
EXTRON 7
EXTRON 5
EVS 3643A, EVS 3643AG, EVS 4343A, EVS 4343AG
RSM 2430C
EXPD 4357, EXPD 4357P
EXPD 114P
EXPD 114G
EXPD 114PG
EXPD 114
Establishment Types
Manufacture Medical Device