The following data is part of a premarket notification filed by Ewoo Soft Co., Ltd with the FDA for Ez3d-i/e3.
| Device ID | K150761 |
| 510k Number | K150761 |
| Device Name: | Ez3D-i/E3 |
| Classification | System, Image Processing, Radiological |
| Applicant | EWOO SOFT CO., LTD S-402, 231 PANGYOYEOK-RO BUNDANG-GU Seongnam, KR 463-400 |
| Contact | Young Seok Kim |
| Correspondent | Priscilla Chung LK Consulting Group USA, Inc. 2651 E Chapman Ave Ste 110 Fullerton, CA 92831 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-23 |
| Decision Date | 2015-06-05 |
| Summary: | summary |