The following data is part of a premarket notification filed by Samsung Electronics Co.,ltd. with the FDA for Auto Lung Nodule Detection.
| Device ID | K201560 |
| 510k Number | K201560 |
| Device Name: | Auto Lung Nodule Detection |
| Classification | Analyzer, Medical Image |
| Applicant | Samsung Electronics Co.,Ltd. 129, Samsung-Ro, Yeongtong-Gu Suwon-si, KR 16677 |
| Contact | Jaesang Noh |
| Correspondent | Jaesang Noh Samsung Electronics Co.,Ltd. 129, Samsung-Ro, Yeongtong-Gu Suwon-si, KR 16677 |
| Product Code | MYN |
| CFR Regulation Number | 892.2070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-10 |
| Decision Date | 2021-08-31 |
| Summary: | summary |