GC85A— 510(k) K160997

Substantially Equivalent

Samsung Electronics Co., Ltd.

FDA 510(k) clearance K160997 for GC85A, Substantially Equivalent on 2016-07-06. Applicant: Samsung Electronics Co., Ltd..

Clearance details

Applicant: Samsung Electronics Co., Ltd.
Product code: Code KPR
Advisory panel: Radiology
Date received: 2016-04-11
Decision date: 2016-07-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Suwon-Si,, KR

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.