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 | K130419 |
| 510k Number | K130419 |
| Device Name: | PAPAYA PLUS, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM |
| Classification | System, X-ray, Extraoral Source, Digital |
| Applicant | GENORAY CO., LTD. 1073 N. Batavia St Orange, CA 92867 |
| Contact | Jae Kim |
| Correspondent | Jae Kim GENORAY CO., LTD. 1073 N. Batavia St Orange, CA 92867 |
| Product Code | MUH |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-02-19 |
| Decision Date | 2013-11-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809244061110 | K130419 | 000 |
| 08809244061103 | K130419 | 000 |