The following data is part of a premarket notification filed by Neusoft Medical Systems Co., Ltd. with the FDA for Modification To Neuviz Dual Multi-slice Ct Scanner System.
| Device ID | K071308 |
| 510k Number | K071308 |
| Device Name: | MODIFICATION TO NEUVIZ DUAL 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, Liaoning, CN 110179 |
| Contact | Tian Yanfang |
| Correspondent | Tian Yanfang NEUSOFT MEDICAL SYSTEMS CO., LTD. NO. 16, SHIJI ROAD HUNNAN INDUSTRIAL AREA Shenyang, Liaoning, 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 | 2007-05-09 |
| Decision Date | 2007-08-16 |
| Summary: | summary |