The following data is part of a premarket notification filed by Hinacom Software And Technology, Ltd with the FDA for Miplatform Medical Imaging Suite V3.0 (miplatform V3.0), Miplatform Zfp Viewer.
| Device ID | K171977 |
| 510k Number | K171977 |
| Device Name: | MiPlatform Medical Imaging Suite V3.0 (miPlatform V3.0), MiPlatform ZFP Viewer |
| Classification | System, Image Processing, Radiological |
| Applicant | Hinacom Software And Technology, Ltd Suite B301, R&D Plaza, Tsinghua Science Park, Haidian Distr. Beijing, CN 100084 |
| Contact | Yi Isabelle Sun |
| Correspondent | Yi Isabelle Sun Hinacom Software And Technology, Ltd Suite B301, R&D Plaza, Tsinghua Science Park, Haidian Distr. Beijing, CN 100084 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-30 |
| Decision Date | 2018-08-02 |
| Summary: | summary |