The following data is part of a premarket notification filed by Genoray Co., Ltd. with the FDA for Papaya Plus, Digital Extraoral Source X-ray System.
| Device ID | K141700 |
| 510k Number | K141700 |
| Device Name: | PAPAYA PLUS, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM |
| Classification | System, X-ray, Extraoral Source, Digital |
| Applicant | GENORAY CO., LTD. 3002 DOW AVENUE, SUITE 420 Tustin, CA 92780 |
| Contact | Kaitlynn Min |
| Correspondent | Kaitlynn Min GENORAY CO., LTD. 3002 DOW AVENUE, SUITE 420 Tustin, CA 92780 |
| Product Code | MUH |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-06-24 |
| Decision Date | 2014-10-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809244061110 | K141700 | 000 |
| 08809244061103 | K141700 | 000 |
| 08809244061172 | K141700 | 000 |
| 08809244061165 | K141700 | 000 |