The following data is part of a premarket notification filed by Neusoft Medical Systems Co., Ltd. with the FDA for Neuviz 16 Essence Multi-slice Ct Scanner System.
| Device ID | K171198 |
| 510k Number | K171198 |
| Device Name: | NeuViz 16 Essence Multi-slice CT Scanner System |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | Neusoft Medical Systems Co., Ltd. No. 16, Shiji Road Hunnan Industrial Area Shenyang, CN 110179 |
| Contact | Shao Xiancheng |
| Correspondent | Shao Xiancheng Neusoft Medical Systems Co., Ltd. No. 16, Shiji Road Hunnan Industrial Area Shenyang, CN 110179 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-04-24 |
| Decision Date | 2017-12-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06970167440084 | K171198 | 000 |