The following data is part of a premarket notification filed by Genoray Co., Ltd. with the FDA for Papaya & Papaya Plus.
| Device ID | K220423 |
| 510k Number | K220423 |
| Device Name: | PAPAYA & PAPAYA Plus |
| Classification | System, X-ray, Extraoral Source, Digital |
| 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 | MUH |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-02-14 |
| Decision Date | 2022-05-19 |