EXSYS DEXi (EXSYS DEXi-S40S); EXSYS DEXi (EXSYS DEXi-S40P); EXSYS DEXi (EXSYS DEXi-S40T); EXSYS DEXi (EXSYS DEXi-S50H— 510(k) K260227

Name: FDA 510(k) clearance K260227
Creator: U.S. Food and Drug Administration
Published: 2026-09-08

Substantially Equivalent

DRTECH 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.

Clearance details

Applicant: DRTECH Corporation
Product code: Code KPR
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 2026-01-26
Decision date: 2026-09-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seongnam-Si, KR

Download summary PDF View on FDA.gov ↗

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More clearances from DRTECH Corporation

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K261413 — EXTRON 3; EXTRON 62026-08-19
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K242770 — EXPD 114; EXPD 114G; EXPD 114P; EXPD 114PG2025-03-20
K243443 — EXPD 4343N1 +9 more2025-03-19
K242591 — XERO-alpha2024-11-01

Adverse events under product code KPR

product code KPR

Other: 6
Total: 6

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.