The following data is part of a premarket notification filed by Hdx Will Corp. with the FDA for Will3d.
| Device ID | K211114 |
| 510k Number | K211114 |
| Device Name: | Will3D |
| Classification | System, Image Processing, Radiological |
| Applicant | HDX WILL CORP. #105, 106, 201, 202, 203, 204, 38, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu Cheongju-si, KR 28161 |
| Contact | Kim In-young |
| Correspondent | Kim In-young HDX WILL CORP. #105, 106, 201, 202, 203, 204, 38, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu Cheongju-si, KR 28161 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-04-14 |
| Decision Date | 2021-12-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800005200298 | K211114 | 000 |