Auto Lung Nodule Detection— 510(k) K201560

Name: FDA 510(k) clearance K201560
Creator: U.S. Food and Drug Administration
Published: 2021-08-31

Substantially Equivalent

Samsung Electronics Co., Ltd.

FDA 510(k) clearance K201560 for Auto Lung Nodule Detection, Substantially Equivalent on 2021-08-31. Applicant: Samsung Electronics Co., Ltd.. Device class: 2.

Clearance details

Applicant: Samsung Electronics Co., Ltd.
Product code: Code MYN
Device class: Class 2
Regulation: 21 CFR 892.2070
Advisory panel: Radiology
Date received: 2020-06-10
Decision date: 2021-08-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Suwon-Si, KR

Download summary PDF View on FDA.gov ↗

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