The following data is part of a premarket notification filed by Genoray Co., Ltd. with the FDA for Papaya 3d Plus.
| Device ID | K150354 |
| 510k Number | K150354 |
| Device Name: | PAPAYA 3D Plus |
| Classification | X-ray, Tomography, Computed, Dental |
| Applicant | GENORAY CO., LTD. 512 BYUCKSAN TECHNOPIA 434-6 SANGDAEWON 1-DONG, JUNGWON-GU Seongnam-city, KR 462-716 |
| Contact | Kyoung-hwa Kim |
| Correspondent | Kaitlynn Min GENORAY AMERICA INC. 3002 Dow Avenue, Suite 420 Tustin, CA 92780 |
| Product Code | OAS |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-02-11 |
| Decision Date | 2015-12-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809244061134 | K150354 | 000 |
| 08809244061127 | K150354 | 000 |
| 08809244061196 | K150354 | 000 |
| 08809244061189 | K150354 | 000 |