# DRTECH Corporation

- Location (FDA's records): Seongnam-Si, KR
- FDA decisions: 33 (2008–2026): 33 510(k) clearances
- Names in FDA's records: DRTECH Corporation (27); Drtech Corp. (6)
- Product codes: MQB (18), KPR (5), MUE (3), LLZ (3), OWB (3), EHD (1)
- 510(k) review time since 2016: median 99 days, against 95 for FDA's reviews in the same codes and years (10 of 23 faster)
- Predicates its devices cite: 37 (23 its own); citations of its devices by later devices: 37 (23 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Carestream Health, Inc.: 2 (https://510kreport.com/company/carestream-health)
- Imfou Co., Ltd.: 2 (https://510kreport.com/company/imfou)
- Philips Medical Systems Nethrlands BV: 2 (https://510kreport.com/company/philips-medical-systems-nethrlands)
- E-Woo Technology: 1 (https://510kreport.com/company/e-woo-technology)
- VATECH Co., Ltd.: 1 (https://510kreport.com/company/vatech)
- New Medical Co., Ltd.: 1 (https://510kreport.com/company/new-medical)
- DRGEM Corporation: 1 (https://510kreport.com/company/drgem)
- Medicatech USA: 1 (https://510kreport.com/company/medicatech-usa)

## Firms that cite its devices most
- Vieworks Co., Ltd.: 3 (https://510kreport.com/company/vieworks)
- Medicatech USA: 3 (https://510kreport.com/company/medicatech-usa)
- Imix Adr Finland OY: 2 (https://510kreport.com/company/imix-adr-finland)
- Rayence Co., Ltd.: 1 (https://510kreport.com/company/rayence)
- Atlaim Corporation: 1 (https://510kreport.com/company/atlaim)
- Aspen Imaging Healthcare, Inc.: 1 (https://510kreport.com/company/aspen-imaging-healthcare)
- Skanray Technologies Limited: 1 (https://510kreport.com/company/skanray-technologies)
- Choong Wae Medical Corp.: 1 (https://510kreport.com/company/choong-wae-medical)

## Its most-cited devices
- K080064: Flaatz 750 (2008), cited by 8
- K231225: EConsole1 (2023), cited by 3
- K192400: Evs 4343A, Evs 4343AG, Evs 3643A, Evs 3643AG (2019), cited by 3
- K142475: EVS 4343 (2015), cited by 2
- K162552: Evs 3643, Evs 3643G (2016), cited by 2
- K111583: Flaatz 560 (2011), cited by 2

## Recent decisions
- K260227: EXSYS DEXi (EXSYS DEXi-S40S); EXSYS DEXi (EXSYS DEXi-S40P); EXSYS DEXi (EXSYS DEXi-S40T); EXSYS DEXi (EXSYS DEXi-S50H (Sep 8, 2026)
- K261413: Extron 3;Extron 6 (Aug 19, 2026)
- K250010: Extron 3; Extron 5; Extron 7 (Jun 10, 2025)
- K242770: Expd 114; Expd 114G; Expd 114P; Expd 114PG (Mar 20, 2025)
- K243443: Expd 4343N1; Expd 4343N; Expd 4343U1; Expd 4343NU; Expd 4343NP; Expd 3643N1; Expd 3643N; Expd 3643U1; Expd 3643NU; Expd 3643NP (Mar 19, 2025)
- K242591: XERO-alpha (Nov 1, 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); (Oct 23, 2024)
- K240243: EConsole2 (Sep 23, 2024)

Source page: https://510kreport.com/company/drtech