GM85— 510(k) K222353

Substantially Equivalent

Samsung Electronics Co., Ltd.

FDA 510(k) clearance K222353 for GM85, Substantially Equivalent on 2022-09-29. Applicant: Samsung Electronics Co., Ltd..

Clearance details

Applicant: Samsung Electronics Co., Ltd.
Product code: Code IZL
Advisory panel: Radiology
Date received: 2022-08-04
Decision date: 2022-09-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Suwon-Si, 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.