The following data is part of a premarket notification filed by Neusoft Medical Systems Co., Ltd. with the FDA for Neusoft Spiral Ct Scanner System, Model Neuviz Version 2.0.
| Device ID | K080540 |
| 510k Number | K080540 |
| Device Name: | NEUSOFT SPIRAL CT SCANNER SYSTEM, MODEL NEUVIZ VERSION 2.0 |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | NEUSOFT MEDICAL SYSTEMS CO., LTD. NO.3-11, WENHUA ROAD HEPING DISTRICT Shenyang, Liaoning, CN 110004 |
| Contact | Tian Yanfang |
| Correspondent | Tamas Borsai TUV RHEINLAND OF NORTH AMERICA, INC. 12 COMMERCE RD. Newton, CT 06470 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-02-27 |
| Decision Date | 2008-03-13 |
| Summary: | summary |