The following data is part of a premarket notification filed by Ray Co.,ltd with the FDA for Rct700.
| Device ID | K160525 |
| 510k Number | K160525 |
| Device Name: | RCT700 |
| Classification | X-ray, Tomography, Computed, Dental |
| Applicant | RAY CO.,LTD 332-7, SAMSUNG 1-RO Hwaseong-si, KR 445-330 |
| Contact | Changhwan Lee |
| Correspondent | Jeff Rongero UL LLC 12 LABORATORY DRIVE Research Triangle Park, NC 27709 |
| Product Code | OAS |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-25 |
| Decision Date | 2016-06-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800003001255 | K160525 | 000 |
| 08800003001026 | K160525 | 000 |
| 08800003001033 | K160525 | 000 |
| 08800003001040 | K160525 | 000 |
| 08800003001057 | K160525 | 000 |
| 08800003001064 | K160525 | 000 |
| 08800003001071 | K160525 | 000 |
| 08800003001088 | K160525 | 000 |
| 08800003001095 | K160525 | 000 |
| 08800003001101 | K160525 | 000 |
| 08800003001118 | K160525 | 000 |
| 08800003001125 | K160525 | 000 |
| 08800003001132 | K160525 | 000 |
| 08800003001149 | K160525 | 000 |
| 08800003001156 | K160525 | 000 |
| 08800003001163 | K160525 | 000 |
| 08800003001170 | K160525 | 000 |
| 08800003001200 | K160525 | 000 |
| 08800003001019 | K160525 | 000 |