The following data is part of a premarket notification filed by Ray Co.,ltd with the FDA for Ris500.
| Device ID | K143000 |
| 510k Number | K143000 |
| Device Name: | RIS500 |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | RAY CO.,LTD 332-7, SAMSUNG 1-RO Hwaseong-si, KR 443-823 |
| Contact | Kyungha Seo |
| Correspondent | Andrew Paeng ANDREW PAENG 4747 HOEN AVE Santa Rosa, CA 95405 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-10-17 |
| Decision Date | 2015-01-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800003002023 | K143000 | 000 |
| 08800003002016 | K143000 | 000 |