The following data is part of a premarket notification filed by Genoray Co., Ltd. with the FDA for Papaya 3d & Papaya 3d Plus.
| Device ID | K220392 |
| 510k Number | K220392 |
| Device Name: | PAPAYA 3D & PAPAYA 3D Plus |
| Classification | X-ray, Tomography, Computed, Dental |
| Applicant | GENORAY Co., Ltd. #512, 560, Dunchon-daero, Jungwon-gu Seongnam-si, KR 13230 |
| Contact | Jiyeon Lee |
| Correspondent | Kaitlynn Min GENORAY America Inc. 147 E. Bristol Lane Orange, CA 92865 |
| Product Code | OAS |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-02-11 |
| Decision Date | 2022-05-19 |