Auto Lung Nodule Detection is an AI-enabled medical device from Samsung Electronics Co.,Ltd. that the U.S. FDA cleared through 510(k) K201560 on August 31, 2021. Its lead review panel is Radiology and its primary product code is MYN (Analyzer, Medical Image).
See also FDA-cleared AI radiology devices in 2021, all FDA AI clearances in 2021, top radiology AI devices.
Key facts
| Submission number | K201560 |
|---|---|
| Pathway | 510(k) |
| Date of final decision | |
| Company (FDA list) | Samsung Electronics Co.,Ltd. |
| Lead review panel | Radiology |
| Primary product code | MYN — Analyzer, Medical Image |
| Applicant (openFDA) | Samsung Electronics Co., Ltd. |
| Applicant location | Suwon-Si, KR |
| Device class | Class 2 |
| Regulation number | 21 CFR 892.2070 |
| Decision code | SESE |
| Submission type | Traditional |
Source: FDA AI-Enabled Medical Devices list and openFDA.
What this means
A 510(k) is a premarket submission showing the device is substantially equivalent to a legally marketed predicate device. A cleared 510(k) means FDA agreed with that equivalence. Auto Lung Nodule Detection went through this pathway (K201560).
openFDA lists it as a Class 2 device under 21 CFR 892.2070. Class II devices are moderate risk and are subject to general and special controls.
Product code MYN covers 43 devices on the FDA AI list. By decision date, this device is #8 of 43 under that code. Samsung Electronics Co.,Ltd. has 1 AI-enabled device on the list, and the Radiology panel accounts for 1,230 in total.
Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.