EXSYS DEXi (EXSYS DEXi-S40S); EXSYS DEXi (EXSYS DEXi-S40P); EXSYS DEXi (EXSYS DEXi-S40T); EXSYS DEXi (EXSYS DEXi-S50H— 510(k) K260227
Substantially EquivalentDRTECH Corporation
FDA 510(k) clearance K260227 for EXSYS DEXi (EXSYS DEXi-S40S); EXSYS DEXi (EXSYS DEXi-S40P); EXSYS DEXi (EXSYS DEXi-S40T); EXSYS DEXi (EXSYS DEXi-S50H, Substantially Equivalent on 2026-09-08. Applicant: DRTECH Corporation. Device class: 2.
Summary
DRTECH's EXSYS DEXi appears in the record in four models: S40S, S40P, S40T, and S50H. The device name is cut off after the fourth model, so the list may be incomplete. Product code KPR covers stationary x-ray systems.
Class II, 21 CFR 892.1680. Radiology is both the classification panel and the review panel. It was a Traditional 510(k).
DRTECH filed from Seongnam-Si, South Korea. The decision came 225 calendar days after FDA received it (January 26 to September 8, 2026).
Clearance details
- Applicant
- DRTECH Corporation
- Product code
- Product code KPR
- Device class
- Class 2
- Regulation
- 21 CFR 892.1680
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Seongnam-Si, KR
Recent devices under product code KPR
view allMore clearances from DRTECH Corporation
view allAdverse events under product code KPR
product code KPR- Other
- 6
- Total
- 6
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.