510(k) clearance
EXSYS DEXi (EXSYS DEXi-S40S); EXSYS DEXi (EXSYS DEXi-S40P); EXSYS DEXi (EXSYS DEXi-S40T); EXSYS DEXi (EXSYS DEXi-S50H
- 510(k) number
- K260227
- Applicant
- DRTECH Corporation
- Decision date
- Sep 8, 2026
- Date received
- Jan 26, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- KPR
- Device type
- System, X-Ray, Stationary
- Device class
- Class II
- Regulation
- 21 CFR 892.1680
- Advisory committee
- Radiology
- Statement or summary
- Summary
- Third party
- N
- Location
- Seongnam-Si, KR