The following data is part of a premarket notification filed by Ewoo Soft Co., Ltd with the FDA for Ez3d-i, E3.
| Device ID | K131616 |
| 510k Number | K131616 |
| Device Name: | EZ3D-I, E3 |
| Classification | System, Image Processing, Radiological |
| Applicant | EWOO SOFT CO., LTD 12946 KIMBERLEY LN Houston, TX 77079 |
| Contact | Dave Kim |
| Correspondent | Dave Kim EWOO SOFT CO., LTD 12946 KIMBERLEY LN Houston, TX 77079 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-03 |
| Decision Date | 2013-08-29 |
| Summary: | summary |