Auto Lung Nodule Detection
FDA 510(k) K201560 · Samsung Electronics Co., Ltd.
510(k) numberK201560
Submission
- Device name
- Auto Lung Nodule Detection
- Applicant
- Samsung Electronics Co., Ltd.
Suwon-Si, KR - Received
- June 10, 2020
- Decision date
- August 31, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MYN – Analyzer, Medical Image
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 892.2070
- Specialty
- Radiology
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
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Questions and answers
When was Auto Lung Nodule Detection cleared by the FDA?
Auto Lung Nodule Detection (K201560) received a 510(k) decision of Substantially Equivalent on August 31, 2021, 447 days after the submission was received.
What is the product code of K201560?
The FDA product code is MYN – Analyzer, Medical Image, a Class II (moderate risk) device regulated under 21 CFR 892.2070.