Cleared Traditional

K201560 - Auto Lung Nodule Detection
(FDA 510(k) Clearance)

K201560 · Samsung Electronics Co., Ltd. · Radiology
Aug 2021
Decision
447d
Days
Class 2
Risk

K201560 is an FDA 510(k) clearance for the Auto Lung Nodule Detection. This device is classified as a Analyzer, Medical Image (Class II — Special Controls, product code MYN).

Submitted by Samsung Electronics Co., Ltd. (Suwon-Si, KR). The FDA issued a Cleared decision on August 31, 2021, 447 days after receiving the submission on June 10, 2020.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2070. For Information On The Myn Device, Please See: Https://www.federalregister.gov/documents/2020/01/22/2020-00494/radiology-devices-reclassification-of-medical-image-analyzers.

Submission Details

510(k) Number K201560 FDA.gov
FDA Decision Cleared SESE
Date Received June 10, 2020
Decision Date August 31, 2021
Days to Decision 447 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code MYN — Analyzer, Medical Image
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.2070
Definition For Information On The Myn Device, Please See: Https://www.federalregister.gov/documents/2020/01/22/2020-00494/radiology-devices-reclassification-of-medical-image-analyzers