The following data is part of a premarket notification filed by Ewoosoft Co., Ltd. with the FDA for Ez3d-i/e3.
| Device ID | K190791 |
| 510k Number | K190791 |
| Device Name: | Ez3D-i/E3 |
| Classification | System, Image Processing, Radiological |
| Applicant | EwooSoft Co., Ltd. 801-ho, Vatechnetworks Bldg. 13, Samsung 1-ro 2-gil Hwaseong-si, KR 18449 |
| Contact | Young Seok Kim |
| Correspondent | Priscilla Chung LK Consulting Group USA, Inc. 1150 Roosevelt STE 200 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 | 2019-03-27 |
| Decision Date | 2019-04-19 |