XGEO GU60— 510(k) K123105

Substantially Equivalent

Samsung Electronics Co., Ltd.

FDA 510(k) clearance K123105 for XGEO GU60, Substantially Equivalent on 2013-06-07. Applicant: Samsung Electronics Co., Ltd..

Clearance details

Applicant: Samsung Electronics Co., Ltd.
Product code: Code KPR
Advisory panel: Radiology
Date received: 2012-10-02
Decision date: 2013-06-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Echo, OR, US

Download summary PDF View on FDA.gov ↗

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.