XPLUS 35 Series (XPLUS 35, XPLUS 35FD)— 510(k) K233200

Name: FDA 510(k) clearance K233200
Creator: U.S. Food and Drug Administration
Published: 2023-11-16

Substantially Equivalent

GEMSS HEALTHCARE CO., LTD.

FDA 510(k) clearance K233200 for XPLUS 35 Series (XPLUS 35, XPLUS 35FD), Substantially Equivalent on 2023-11-16. Applicant: GEMSS HEALTHCARE CO., LTD.. Device class: 2.

Clearance details

Applicant: GEMSS HEALTHCARE CO., LTD.
Product code: Code OWB
Device class: Class 2
Regulation: 21 CFR 892.1650
Advisory panel: Radiology
Date received: 2023-09-28
Decision date: 2023-11-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Paju-Si, KR

Download summary PDF View on FDA.gov ↗

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Adverse events under product code OWB

product code OWB

Death: 49
Injury: 340
Malfunction: 36,973
Total: 37,362

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.