The following data is part of a premarket notification filed by Ewoo Soft Co., Ltd. with the FDA for Ez3d Plus.
| Device ID | K152746 |
| 510k Number | K152746 |
| Device Name: | Ez3D Plus |
| Classification | System, Image Processing, Radiological |
| Applicant | EWOO SOFT CO., LTD. 401-1-HO, 13, SAMSUNG 1-RO 2-GIL Hwaseong-si, KR 18449 |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-23 |
| Decision Date | 2016-01-03 |
| Summary: | summary |