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 a medical device manufactured by Samsung Electronics Co., Ltd.. It received FDA 510(k) clearance on 2021-08-31 under approval 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. It is manufactured by Samsung Electronics Co., Ltd.. The 510(k) number is K201560.
When was Auto Lung Nodule Detection approved by the FDA?
Auto Lung Nodule Detection received FDA 510(k) clearance on 2021-08-31, under approval number K201560.
What company makes Auto Lung Nodule Detection?
Auto Lung Nodule Detection is manufactured by Samsung Electronics Co., Ltd..
What is the FDA product code for Auto Lung Nodule Detection?
The FDA product code for Auto Lung Nodule Detection is MYN.
Other Devices by Samsung Electronics Co., Ltd.
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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.