The following data is part of a premarket notification filed by Ewoo Soft Co., Ltd. with the FDA for Ez3d-i / E3.
| Device ID | K161246 |
| 510k Number | K161246 |
| Device Name: | Ez3D-i / E3 |
| Classification | System, Image Processing, Radiological |
| Applicant | EWOO SOFT CO., LTD. 801-HO, 6, SAMSUNG 1-RO 1-GIL Hwaseong-si, KR 18449 |
| Contact | Young Seok Kim |
| Correspondent | Priscilla Chung LK Consulting Group USA, Inc. 800 ROOSEVELT STE 417 Irvine, CA 92620 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-03 |
| Decision Date | 2016-05-31 |
| Summary: | summary |