GC70, GU60A, GU60A-65, GF50, GR50A; GR40CW; GM85; GC85A— 510(k) K182183

Name: FDA 510(k) clearance K182183
Creator: U.S. Food and Drug Administration
Published: 2018-12-07

Substantially Equivalent

Samsung Electronics Co., Ltd.

FDA 510(k) clearance K182183 for GC70, GU60A, GU60A-65, GF50, GR50A; GR40CW; GM85; GC85A, Substantially Equivalent on 2018-12-07. Applicant: Samsung Electronics Co., Ltd.. Device class: 2.

Clearance details

Device name as filed: GC70, GU60A, GU60A-65, GF50, GR50A ; GR40CW ; GM85 ; GC85A
Applicant: Samsung Electronics Co., Ltd.
Product code: Code KPR
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 2018-08-13
Decision date: 2018-12-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Suwon-Si, KR

Download summary PDF View on FDA.gov ↗

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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.