The following data is part of a premarket notification filed by Neusoft Medical Systems Co., Ltd. with the FDA for Neuviz 64 Multi-slice Ct Scanner System.
| Device ID | K121792 |
| 510k Number | K121792 |
| Device Name: | NEUVIZ 64 MULTI-SLICE CT SCANNER SYSTEM |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | NEUSOFT MEDICAL SYSTEMS CO., LTD. 77325 JOYCE WAY Echo, OR 97826 |
| Contact | Charles Mack |
| Correspondent | Charles Mack NEUSOFT MEDICAL SYSTEMS CO., LTD. 77325 JOYCE WAY Echo, OR 97826 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-06-28 |
| Decision Date | 2012-11-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06970167440039 | K121792 | 000 |
| 06970167440022 | K121792 | 000 |
| 06970167440015 | K121792 | 000 |
| 06970167440008 | K121792 | 000 |