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FDA 510(k), K201560, Auto Lung Nodule Detection
FDA 510(k), K201560, Auto Lung Nodule Detection
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510(K) Number: K201560
Device Name: Auto Lung Nodule Detection
Manufacturer: Jaesang Noh
Device Classification Name: Analyzer, Medical Image
Regulation Number: MYN
Classification Product Code: 06/10/2020
Date Received: 08/31/2021
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
Device Name: Auto Lung Nodule Detection
Manufacturer: Jaesang Noh
Device Classification Name: Analyzer, Medical Image
Regulation Number: MYN
Classification Product Code: 06/10/2020
Date Received: 08/31/2021
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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