FDA 510(k) Applications Submitted by NEUSOFT MEDICAL SYSTEMS CO., LTD.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K071154 |
04/25/2007 |
SUPERSTAR 0.35T MRI SYSTEM |
NEUSOFT MEDICAL SYSTEMS CO., LTD. |
| K121792 |
06/28/2012 |
NEUVIZ 64 MULTI-SLICE CT SCANNER SYSTEM |
NEUSOFT MEDICAL SYSTEMS CO., LTD. |
| K171198 |
04/24/2017 |
NeuViz 16 Essence Multi-slice CT Scanner System |
Neusoft Medical Systems Co., Ltd. |
| K171201 |
04/24/2017 |
NeuViz Prime Multi-slice CT Scanner System |
Neusoft Medical Systems Co., Ltd. |
| K072841 |
10/04/2007 |
NEUVIZ SPIRAL CT SCANNER SYSTEM |
NEUSOFT MEDICAL SYSTEMS CO., LTD. |
| K090173 |
01/23/2009 |
NEUVIZ 16 MULTI-SLICE CT SCANNER SYSTEM |
NEUSOFT MEDICAL SYSTEMS CO., LTD. |
| K080540 |
02/27/2008 |
NEUSOFT SPIRAL CT SCANNER SYSTEM, MODEL NEUVIZ VERSION 2.0 |
NEUSOFT MEDICAL SYSTEMS CO., LTD. |
| K090552 |
03/02/2009 |
UROCARE |
NEUSOFT MEDICAL SYSTEMS CO., LTD. |
| K061132 |
04/24/2006 |
MODIFICATION TO SUPEROPEN 0.35T, MODEL NSM-P035 |
NEUSOFT MEDICAL SYSTEMS CO., LTD. |
| K071308 |
05/09/2007 |
MODIFICATION TO NEUVIZ DUAL MULTI-SLICE CT SCANNER SYSTEM |
NEUSOFT MEDICAL SYSTEMS CO., LTD. |
| K062451 |
08/22/2006 |
NEUVIZ DUAL MULTI-SLICE CT SCANNER SYSTEM |
NEUSOFT MEDICAL SYSTEMS CO., LTD. |
| K082485 |
08/28/2008 |
MODIFICATION TO SUPEROPEN 0.23T MRI SYSTEM, MODEL NAM-P023A |
NEUSOFT MEDICAL SYSTEMS CO., LTD. |
| K062860 |
09/25/2006 |
MODIFICATION TO SUPEROPEN 0.23T, MODEL NAM-P023A |
NEUSOFT MEDICAL SYSTEMS CO., LTD. |
| K083877 |
12/29/2008 |
FLYING DIAGNOSTIC ULTRASOUND SYSTEM |
NEUSOFT MEDICAL SYSTEMS CO., LTD. |
| K092742 |
09/08/2009 |
NEUVIZ 16 MULTI-SLICE CT SCANNER SYSTEM |
NEUSOFT MEDICAL SYSTEMS CO., LTD. |
| K110077 |
01/11/2011 |
NEUCOLONCARE |
NEUSOFT MEDICAL SYSTEMS CO., LTD. |
| K151383 |
05/22/2015 |
NeuViz 128 Multi-slice CT Scanner System |
NEUSOFT MEDICAL SYSTEMS CO., LTD. |
| K151403 |
05/26/2015 |
Positron Emission Tomography (PET) and Computed Tomography (CT) System, Positron Emission Tomography (PET) and Computed Tomography (CT) System |
NEUSOFT MEDICAL SYSTEMS CO., LTD. |
| K092235 |
07/23/2009 |
BEYONDIMAGE WORKSTATION |
NEUSOFT MEDICAL SYSTEMS CO., LTD. |
| K092237 |
07/23/2009 |
NSM-S15 SYSTEM |
NEUSOFT MEDICAL SYSTEMS CO., LTD. |
| K102435 |
08/26/2010 |
BEYONDIMAGE WORKSTATION |
NEUSOFT MEDICAL SYSTEMS CO., LTD. |
| K133373 |
11/01/2013 |
CLEARVIEW |
NEUSOFT MEDICAL SYSTEMS CO., LTD. |
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