GM60A-32S, GM60A-40S— 510(k) K142492

Substantially Equivalent

Samsung Electronics Co., Ltd.

FDA 510(k) clearance K142492 for GM60A-32S, GM60A-40S, Substantially Equivalent on 2014-12-17. Applicant: Samsung Electronics Co., Ltd..

Clearance details

Applicant: Samsung Electronics Co., Ltd.
Product code: Code IZL
Advisory panel: Radiology
Date received: 2014-09-04
Decision date: 2014-12-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Suwon-Si, Gyeonggi-Do, KR

Download summary PDF View on FDA.gov ↗

Adverse events under product code IZL

product code IZL

Other: 3
Total: 3

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.