The following data is part of a premarket notification filed by Xian Wingspan Electronic Technology Co., Ltd. with the FDA for Restore Pacs.
| Device ID | K162141 |
| 510k Number | K162141 |
| Device Name: | Restore PACS |
| Classification | System, Image Processing, Radiological |
| Applicant | XIAN WINGSPAN ELECTRONIC TECHNOLOGY CO., LTD. Rm. A608, Pioneering Square, No. 48 Keji Rd., Gaoxin Dist. Xi'an, CN 710075 |
| Contact | Echo Chou |
| Correspondent | Echo Chou XIAN WINGSPAN ELECTRONIC TECHNOLOGY CO., LTD. Rm. A608, Pioneering Square, No. 48 Keji Rd., Gaoxin Dist. Xi'an, CN 710075 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-01 |
| Decision Date | 2016-09-02 |
| Summary: | summary |