The following data is part of a premarket notification filed by Dalian Senyint Digital Medical System Co., Ltd. with the FDA for Senyint Remote Consultation System.
| Device ID | K162727 |
| 510k Number | K162727 |
| Device Name: | SENYINT Remote Consultation System |
| Classification | System, Image Processing, Radiological |
| Applicant | Dalian Senyint Digital Medical System Co., Ltd. Room 403-404, Building 3, East Rd. In Software Park Dalian, CN 116023 |
| Contact | Yinghui Miao |
| Correspondent | Di Wu Di Wu Regulatory 3440 Indian Queen Lane, Rear Philadelphia, PA 19129 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-29 |
| Decision Date | 2018-02-08 |