52 results
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75ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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NEUSOFT MEDICAL SYSTEMS CO., LTD.
FDA registration
NEUSOFT MEDICAL SYSTEMS CO., LTD.·1 product·🇨🇳 China
NeuViz 128 Multi-Slice CT Scanner System
FDA UDI
Neusoft Medical Systems Co., Ltd.·06970167441616·
NeuViz 64 Multi-slice CT Scanner System
FDA UDI
Neusoft Medical Systems Co., Ltd.·06970167440039·
NeuSight PET/CT Scanner System
FDA UDI
Neusoft Medical Systems Co., Ltd.·06970167440060·
NeuViz 128 Multi-slice CT Scanner System
FDA UDI
Neusoft Medical Systems Co., Ltd.·06970167440046·
NeuViz 64 Multi-slice CT Scanner System
FDA UDI
Neusoft Medical Systems Co., Ltd.·06970167440008·
NeuViz 64 Multi-slice CT Scanner System
FDA UDI
Neusoft Medical Systems Co., Ltd.·06970167440022·
NeuViz 64 Multi-slice CT Scanner System
FDA UDI
Neusoft Medical Systems Co., Ltd.·06970167440015·
NeuViz Prime Multi-Slice CT Scanner System
FDA UDI
Neusoft Medical Systems Co., Ltd.·06970167440077·
NeuSight PET/CT Scanner System
FDA UDI
Neusoft Medical Systems Co., Ltd.·06970167440053·
NeuViz 16 Essence Multi-Slice CT Scanner System
FDA UDI
Neusoft Medical Systems Co., Ltd.·06970167440084·
NeuViz 16 Multi-Slice CT Scanner System is a computed Tomography X-ray system, and has a Part number 989605858501. The device is labeled in part: "***Neusoft***NeuViz16 MULTI-SLICE CT SCANNER SYSTEM***MANUFACTURED FOR NEUSOFT MEDICAL SYSTEMS CO., LTD***MANUFACTURED BY PHILIPS AND NEUSOFT MEDICAL SYSTEMS CO., LTD***ADDRESS: NEUSOFT PARK, HUNNAN INDUSTRIAL AREA, SHENYANG***CHINA***".
FDA Enforcement
Class II
·Terminated·Philips And Neusoft Medical Systems Co., Ltd.·August 1, 2012
NEUSOFT POSITRON MEDICAL SYSTEMS CO.,LTD.
FDA registration
NEUSOFT POSITRON MEDICAL SYSTEMS CO.,LTD.·1 product·🇨🇳 China
NeuViz 16 Multi-Slice CT Scanner System is a computed Tomography X-ray system, and has a Part number 989605858501. The device is labeled in part: "***Neusoft***NeuViz16 MULTI-SLICE CT SCANNER SYSTEM***MANUFACTURED FOR NEUSOFT MEDICAL SYSTEMS CO., LTD***MANUFACTURED BY PHILIPS AND NEUSOFT MEDICAL SYSTEMS CO., LTD***ADDRESS: NEUSOFT PARK, HUNNAN INDUSTRIAL AREA, SHENYANG***CHINA***".
FDA Recall
Terminated
·Philips And Neusoft Medical Systems Co., Ltd.·Product code JAK·June 8, 2012
NeuViz 16 Multi-Slice CT Scanner System is a computed Tomography X-ray system, and has a Part number 989605858501. The device is labeled in part: "***Neusoft***NeuViz16 MULTI-SLICE CT SCANNER SYSTEM***MANUFACTURED FOR NEUSOFT MEDICAL SYSTEMS CO., LTD***MANUFACTURED BY PHILIPS AND NEUSOFT MEDICAL SYSTEMS CO., LTD***ADDRESS: NEUSOFT PARK, HUNNAN INDUSTRIAL AREA, SHENYANG***CHINA***".
FDA Recall
Terminated
·Philips And Neusoft Medical Systems Co., Ltd.·Product code JAK·February 9, 2011
NeuViz 16 Multi-Sliced CT Scanner System, part number 989605858501. NeuViz Dual series CT Scanner System, part number 989605651321 The NeuViz 16 CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array with multi-slice capability up to 16 slices simultaneously.
FDA Recall
Terminated
·Philips And Neusoft Medical Systems Co., Ltd.·Product code JAK·October 18, 2012
NEUVIZ 64 IN
FDA Adverse Event
Malfunction
·NEUSOFT MEDICAL SYSTEMS CO., LTD.·Product code JAK·October 29, 2019
The device is the NeuViz Dual series Computed Tomography (CT) Scanner System. The device is identified as NeuViz Dual, PN: 989605651321. Labeling on the device reads in part: "***Neusoft NeuViz Dual MULTI-SLICE CT SCANNER SYSTEM***MANUFACTURED BY PHILIPS AND NEUSOFT MEDICAL SYSTEMS CO., LTD. ADDRESS: NEUSOFT PARK, HUN NAN INDUSTRIAL AREA, SHENYANG 110179, CHINA***". Device is intended to produce cross-section images of head and body by computer reconstruction of x-ray transmission data taken at different angles.
FDA Recall
Terminated
·Philips And Neusoft Medical Systems Co., Ltd. Neusoft Park, Hun Nan Industrial Area Shenyang, Liaoning China·Product code JAK·February 10, 2010
CT SCAN
FDA Adverse Event
Injury
·NEUSOFT MEDICAL SYSTEMS CO., LTD.·Product code JAK·October 7, 2019
NeuViz Dual series CT Scanner System, Part number (PN): 989605651321. This is a computed X-ray, Tomography system. NeuViz Dual Multi-slice CT Scanner System is intended to produce cross-section images of head and body by computer reconstruction of X-ray transmission data taken at different angles.
FDA Recall
Terminated
·Philips And Neusoft Medical Systems Co., Ltd.·Product code JAK·March 4, 2013