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FDA 510(k)

Auto Lung Nodule Detection

K-Number: K201560 · 2021-08-31

ApplicantSamsung Electronics Co., Ltd.
Decision Date2021-08-31
Product CodeMYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Auto Lung Nodule Detection is the device name listed in this FDA 510(k) record. The listed applicant is Samsung Electronics Co., Ltd.. It received FDA 510(k) clearance on 2021-08-31 under 510(k) number K201560. The device is classified under product code MYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Auto Lung Nodule Detection?

Auto Lung Nodule Detection is a medical device that received FDA 510(k) clearance on 2021-08-31. The listed applicant is Samsung Electronics Co., Ltd.. The 510(k) number is K201560.

When did Auto Lung Nodule Detection receive FDA 510(k) clearance?

Auto Lung Nodule Detection received FDA 510(k) clearance on 2021-08-31, under 510(k) number K201560.

Who is the listed applicant for Auto Lung Nodule Detection?

The FDA 510(k) record lists Samsung Electronics Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Auto Lung Nodule Detection?

The FDA product code for Auto Lung Nodule Detection is MYN.

Related Clinical Trials

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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