The following data is part of a premarket notification filed by Dexin Medical Imaging Technology Co., Ltd. with the FDA for Fact Medical Imaging Sysytem.
| Device ID | K143586 |
| 510k Number | K143586 |
| Device Name: | FACT Medical Imaging Sysytem |
| Classification | System, Image Processing, Radiological |
| Applicant | Dexin Medical Imaging Technology Co., Ltd. 227 Chongye Street Weinan Hign-tech Zone, CN 714000 |
| Contact | Wang Yu |
| Correspondent | Leon Lu MEDevice Services, LLC 3500 South Dupont Highway Dover, DE 19901 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-18 |
| Decision Date | 2015-09-02 |
| Summary: | summary |