Neusoft Medical Systems Co., Ltd.
SHENYANG Liaoning, CN
NEUSOFT MEDICAL SYSTEMS CO., LTD. appears in FDA device records in SHENYANG Liaoning, CN. FDA records list 23 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 17 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Neusoft Medical Systems Co., Ltd. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Philips And Neusoft Medical Systems Co., Ltd.enforcement report, recall
510(k) clearance history
FDA records hold 23 510(k) clearances for Neusoft Medical Systems Co., Ltd. between 2006 and 2023. The busiest year on record is 2009, with 6. The most recent is 2023, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2006 | 3 |
| 2007 | 3 |
| 2008 | 2 |
| 2009 | 6 |
| 2010 | 1 |
| 2011 | 1 |
| 2012 | 1 |
| 2014 | 1 |
| 2015 | 2 |
| 2017 | 2 |
| 2023 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K230220 | NeuViz 128 Multi-Slice CT Scanner System | JAK | Substantially Equivalent | |
| K171198 | NeuViz 16 Essence Multi-slice CT Scanner System | JAK | Substantially Equivalent | |
| K171201 | NeuViz Prime Multi-slice CT Scanner System | JAK | Substantially Equivalent | |
| K151383 | NeuViz 128 Multi-slice CT Scanner System | JAK | Substantially Equivalent | |
| K151403 | Positron Emission Tomography (PET) and Computed Tomography (CT) System, Positron Emission Tomography (PET) and Computed Tomography (CT) System | KPS | Substantially Equivalent | |
| K133373 | CLEARVIEW | JAK | Substantially Equivalent | |
| K121792 | NEUVIZ 64 MULTI-SLICE CT SCANNER SYSTEM | JAK | Substantially Equivalent | |
| K110077 | NEUCOLONCARE | LLZ | Substantially Equivalent | |
| K102435 | BEYONDIMAGE WORKSTATION | LLZ | Substantially Equivalent | |
| K092742 | NEUVIZ 16 MULTI-SLICE CT SCANNER SYSTEM | JAK | Substantially Equivalent | |
| K092237 | NSM-S15 SYSTEM | LNH | Substantially Equivalent | |
| K092235 | BEYONDIMAGE WORKSTATION | LLZ | Substantially Equivalent | |
| K090552 | UROCARE | LLZ | Substantially Equivalent | |
| K090173 | NEUVIZ 16 MULTI-SLICE CT SCANNER SYSTEM | JAK | Substantially Equivalent | |
| K083877 | FLYING DIAGNOSTIC ULTRASOUND SYSTEM | ITX | Substantially Equivalent | |
| K082485 | MODIFICATION TO SUPEROPEN 0.23T MRI SYSTEM, MODEL NAM-P023A | LNH | Substantially Equivalent | |
| K080540 | NEUSOFT SPIRAL CT SCANNER SYSTEM, MODEL NEUVIZ VERSION 2.0 | JAK | Substantially Equivalent | |
| K072841 | NEUVIZ SPIRAL CT SCANNER SYSTEM | JAK | Substantially Equivalent | |
| K071308 | MODIFICATION TO NEUVIZ DUAL MULTI-SLICE CT SCANNER SYSTEM | JAK | Substantially Equivalent | |
| K071154 | SUPERSTAR 0.35T MRI SYSTEM | LNH | Substantially Equivalent | |
| K062860 | MODIFICATION TO SUPEROPEN 0.23T, MODEL NAM-P023A | LNH | Substantially Equivalent | |
| K062451 | NEUVIZ DUAL MULTI-SLICE CT SCANNER SYSTEM | JAK | Substantially Equivalent | |
| K061132 | MODIFICATION TO SUPEROPEN 0.35T, MODEL NSM-P035 | LNH | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3003575350 | 3003575350 | NEUSOFT MEDICAL SYSTEMS CO., LTD. | No.177-1 Chuangxin Road, SHENYANG Liaoning 110167 CN | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1281-2019 | NeuViz 16 Essence Multi-slice CT Scanner System Product Usage: The Multi-Slice 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. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images of the body from either the same axial plane taken at different angles or spiral planes taken at different angles. | Software defect: For Helical scan with ClearView function, when small arc (uninterrupted scan) occurs during scan, there will be some electromagnetic interference in the system which may affect the control signal of the flying focal spot, resulting in an incorrect flying focal spot sequence. If the system does not receive error, it would continue to complete the scan with the incorrect flying focal spot sequence, having an effect on the reconstruction of some images, resulting in image loss. | Class II | Terminated | |
| Z-1280-2019 | NeuViz 128 Multi-slice CT Scanner System Product Usage: The Multi-Slice 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. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images of the body from either the same axial plane taken at different angles or spiral planes taken at different angles. | Software defect: For Helical scan with ClearView function, when small arc (uninterrupted scan) occurs during scan, there will be some electromagnetic interference in the system which may affect the control signal of the flying focal spot, resulting in an incorrect flying focal spot sequence. If the system does not receive error, it would continue to complete the scan with the incorrect flying focal spot sequence, having an effect on the reconstruction of some images, resulting in image loss. | Class II | Terminated | |
| Z-1279-2019 | NeuViz 64 Multi-slice CT Scanner System Product Usage: The Multi-Slice 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. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images of the body from either the same axial plane taken at different angles or spiral planes taken at different angles. | Software defect: For Helical scan with ClearView function, when small arc (uninterrupted scan) occurs during scan, there will be some electromagnetic interference in the system which may affect the control signal of the flying focal spot, resulting in an incorrect flying focal spot sequence. If the system does not receive error, it would continue to complete the scan with the incorrect flying focal spot sequence, having an effect on the reconstruction of some images, resulting in image loss. | Class II | Terminated | |
| Z-3045-2017 | Neusoft NeuViz 128 Multi-slice CT Scanner System Product Usage: The Multi-Slice 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. The acquired X-RAY transmission data is reconstructed by computer into cross-sectional images of the body from either the same axial plane taken at different angles or spiral planes taken at different angles. | Software defect | Class II | Terminated | |
| Z-3044-2017 | Neusoft Medical NeuViz 64 Multi-slice CT Scanner System, including: NeuViz 64e, NeuViz 64i with software version 1.0.6.3258 +P11 or previous version, NeuViz 64En, NeuViz 641n with software version 1.0.7.4021+P11 or previous version Product Usage: The Multi-Slice 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. The acquired X-RAY transmission data is reconstructed by computer into cross-sectional images of the body from either the same axial plane taken at different angles or spiral planes taken at different angles. | Software defect | Class II | Terminated | |
| Z-0876-2017 | NeuViz 128 Multi-slice CT Scanner System with software version 1.0.7.4038+P06 or previous version | The Firm discovered during contrast agent tracking scan, when the expected concentration of contrast agent is reached, later planned scan may be interrupted. The system must be powered down and restarted to clear the interruption error before scanning can resume. | Class II | Terminated | |
| Z-0875-2017 | NeuViz 64 Multi-slice CT Scanner Systems | The Firm discovered during contrast agent tracking scan, when the expected concentration of contrast agent is reached, later planned scan may be interrupted. The system must be powered down and restarted to clear the interruption error before scanning can resume. | Class II | Terminated | |
| Z-1573-2016 | NeuViz 16 Multi-Slice CT Scanner System PN: 989605858501 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. | The following issues are found in NeuViz 16 systems with software version 1.1.4.21425 and version 1.1.4.21426: 1) During the filming operation on MX 16-slice console software, the clipboard used for copying and pasting images is not cleared between patients. If the operator fails to copy the current patient's images before pasting, a previous patient's image may be present in the clipboard and be | Class II | Terminated | |
| Z-1650-2016 | NeuViz 64 Multi-Slice CT Scanner System (consist if two variants: NeuViz 64e, NeuViz 64i) | It was found by R&D in April, 2014 that there was a defect in NeuViz 64 system software version 1.0.5+P09. The icons of side decubitus didn't meet the patient position description, when the scanner position was set to "Right" in the system setting - scanner options. | Class II | Terminated | |
| Z-1166-2013 | 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. | User error of the NeuViz 16 or NeuViz Dual may cause personnel injuries. There was a report where a finger was pinched when the table was moved backward while the tabletop was controlled by another person from the gantry left control panel. | Class II | Terminated | |
| Z-1165-2013 | NeuViz 16 Multi-Slice CT Scanner System, Part number (PN): 989605858501, Model: NeuViz 16. This is a computed X-ray, Tomography system. 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. The acquired X-RAY transmission data is reconstructed by computer into cross-sectional images of the body from the same axial plane taken at different angles. The system is suitable for all patients | User error of the NeuViz 16 or NeuViz Dual may cause personnel injuries. There was a report where a finger was pinched when the table was moved backward while the tabletop was controlled by another person from the gantry left control panel. | Class II | Terminated | |
| Z-0466-2013 | 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. | The four screws that secure the patient table top to the carrier pulled out and caused the table top to detach. This issue may affect NeuViz Dual and NeuViz 16 scanners. | Class II | Terminated | |
| Z-2083-2012 | 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***". | One of the four screws that secure the Oil-accumulator to the X-Ray Tube pulled out in the NeuViz 16 CT scanner, which caused the Oil-accumulator to detach. | Class II | Terminated | |
| Z-2241-2011 | 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***". | Dimension measurement displays on a combined image were found inaccurate after the clinician merged multiple image series into one image. | Terminated | ||
| Z-0846-2011 | 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. | Potential for the CT patient table top to become detached from the carrier due to missing washers. | Terminated | ||
| Z-2307-2008 | NeuViz Dual series computed Tomography Scanner System, X-Ray System | Potential for R-host box and components inside to be detached of its mounting during the gantry rotor rotation. There is a potential for components to be damaged inside the system gantry and for the internal components to be expelled from the system gantry and injure the patient, operator, bystander or service people. | Terminated | ||
| Z-2235-2008 | NeuViz Dual series computed Tomography Scanner System, X-Ray System The CT scanner is a whole body x-ray computed tomography scanner which features a continuously rotating tube-detector system and functions according to the fan beam principle. | Labeling of patient position on scanned image does not match actual patient orientation. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain