Neusoft Medical Systems Co., Ltd.
FDA Regulatory Profile
Summary
- Total Recalls
- 8
- 510(k) Clearances
- 23
- Inspections
- 5
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1279-2019 | Class II | NeuViz 64 Multi-slice CT Scanner System Product Usage: The Multi-Slice CT Scanner System can be u | October 22, 2018 |
| Z-1281-2019 | Class II | NeuViz 16 Essence Multi-slice CT Scanner System Product Usage: The Multi-Slice CT Scanner System | October 22, 2018 |
| Z-1280-2019 | Class II | NeuViz 128 Multi-slice CT Scanner System Product Usage: The Multi-Slice CT Scanner System can be | October 22, 2018 |
| Z-3044-2017 | Class II | Neusoft Medical NeuViz 64 Multi-slice CT Scanner System, including: NeuViz 64e, NeuViz 64i wit | May 19, 2017 |
| Z-3045-2017 | Class II | Neusoft NeuViz 128 Multi-slice CT Scanner System Product Usage: The Multi-Slice CT Scanner Sys | May 19, 2017 |
| Z-0875-2017 | Class II | NeuViz 64 Multi-slice CT Scanner Systems | August 31, 2016 |
| Z-0876-2017 | Class II | NeuViz 128 Multi-slice CT Scanner System with software version 1.0.7.4038+P06 or previous version | August 31, 2016 |
| Z-1650-2016 | Class II | NeuViz 64 Multi-Slice CT Scanner System (consist if two variants: NeuViz 64e, NeuViz 64i) | May 2, 2015 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K230220 | NeuViz 128 Multi-Slice CT Scanner System | October 11, 2023 |
| K171198 | NeuViz 16 Essence Multi-slice CT Scanner System | December 7, 2017 |
| K171201 | NeuViz Prime Multi-slice CT Scanner System | September 13, 2017 |
| K151383 | NeuViz 128 Multi-slice CT Scanner System | November 4, 2015 |
| K151403 | Positron Emission Tomography (PET) and Computed Tomography (CT) System, Positron Emission Tomography | November 2, 2015 |
| K133373 | CLEARVIEW | December 3, 2014 |
| K121792 | NEUVIZ 64 MULTI-SLICE CT SCANNER SYSTEM | November 16, 2012 |
| K110077 | NEUCOLONCARE | January 28, 2011 |
| K102435 | BEYONDIMAGE WORKSTATION | October 15, 2010 |
| K092742 | NEUVIZ 16 MULTI-SLICE CT SCANNER SYSTEM | September 22, 2009 |
| K092237 | NSM-S15 SYSTEM | September 9, 2009 |
| K092235 | BEYONDIMAGE WORKSTATION | August 6, 2009 |
| K090552 | UROCARE | March 16, 2009 |
| K090173 | NEUVIZ 16 MULTI-SLICE CT SCANNER SYSTEM | February 5, 2009 |
| K083877 | FLYING DIAGNOSTIC ULTRASOUND SYSTEM | January 13, 2009 |
| K082485 | MODIFICATION TO SUPEROPEN 0.23T MRI SYSTEM, MODEL NAM-P023A | September 9, 2008 |
| K080540 | NEUSOFT SPIRAL CT SCANNER SYSTEM, MODEL NEUVIZ VERSION 2.0 | March 13, 2008 |
| K072841 | NEUVIZ SPIRAL CT SCANNER SYSTEM | October 16, 2007 |
| K071308 | MODIFICATION TO NEUVIZ DUAL MULTI-SLICE CT SCANNER SYSTEM | August 16, 2007 |
| K071154 | SUPERSTAR 0.35T MRI SYSTEM | May 10, 2007 |