The following data is part of a premarket notification filed by 3d Industrial Imaging Co., Ltd. with the FDA for Varo Plan.
| Device ID | K200078 |
| 510k Number | K200078 |
| Device Name: | VARO Plan |
| Classification | System, Image Processing, Radiological |
| Applicant | 3D Industrial Imaging Co., Ltd. Bldg. 138, Rm. 413, Seoul National University, 1 Gwanak-ro Seoul, KR 08826 |
| Contact | Myungsuk Park |
| Correspondent | Sanglok Lee Wise Company Inc. #303, 142, Gasan Digital 1-ro Geumcheon-gu, KR 08507 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-01-14 |
| Decision Date | 2020-04-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800022900089 | K200078 | 000 |