Data / Medical devices / China / Neusoft Medical Systems Co., Ltd.
Neusoft Medical Systems Co., Ltd.: FDA-registered device maker in SHENYANG Liaoning, China, 5 510(k) clearances
Neusoft Medical Systems Co., Ltd. is registered with the FDA (registration 3003575350) in SHENYANG Liaoning, China. It lists 1 device type. The FDA files 5 510(k) clearances under its listings, the newest dated October 11, 2023. 12 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003575350
- Address
- No.177-1 Chuangxin Road Hunnan District, SHENYANG Liaoning, China, 110167
- Owner or operator
- NEUSOFT MEDICAL SYSTEMS CO., LTD. (9050318)
- Roles
- Manufacturer
- First device listed
- November 20, 2012
- Registered through
- 2026
- Brand names listed
- ClearView, NeuViz 128, NeuViz 16 Essence Multi-Slice CT Scanner System, NeuViz 64 In, NeuViz 64 En, NeuViz 64i,NeuViz 64e
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, X-Ray, Tomography, Computed | JAK | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 11, 2023 | K230220 | NeuViz 128 Multi-Slice CT Scanner System | JAK | Substantially Equivalent | Neusoft Medical Systems Co., Ltd. | accessdata.fda.gov |
| December 7, 2017 | K171198 | NeuViz 16 Essence Multi-slice CT Scanner System | JAK | Substantially Equivalent | Neusoft Medical Systems Co., Ltd. | accessdata.fda.gov |
| November 4, 2015 | K151383 | NeuViz 128 Multi-slice CT Scanner System | JAK | Substantially Equivalent | Neusoft Medical Systems Co., Ltd. | accessdata.fda.gov |
| December 3, 2014 | K133373 | CLEARVIEW | JAK | Substantially Equivalent | Neusoft Medical Systems Co., Ltd. | accessdata.fda.gov |
| November 16, 2012 | K121792 | NEUVIZ 64 MULTI-SLICE CT SCANNER SYSTEM | JAK | Substantially Equivalent | Neusoft Medical Systems Co., Ltd. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| October 22, 2018 | 82753 | Class II | Terminated | 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 a | 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 | accessdata.fda.gov |
| May 19, 2017 | 77608 | Class II | Terminated | 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 previ | Software defect | accessdata.fda.gov |
| August 31, 2016 | 75383 | Class II | Terminated | 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. | accessdata.fda.gov |
| March 24, 2016 | 73741 | Class II | Terminated | 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 simultane | 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 | accessdata.fda.gov |
| May 2, 2015 | 73832 | Class II | Terminated | 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. | accessdata.fda.gov |
| March 4, 2013 | 64783 | Class II | Terminated | 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-ra | 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. | accessdata.fda.gov |
| October 18, 2012 | 63553 | Class II | Terminated | 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 sys | 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. | accessdata.fda.gov |
| June 8, 2012 | 62481 | Class II | Terminated | 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 NE | 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. | accessdata.fda.gov |
| February 9, 2011 | 58582 | Not yet classified | Terminated | 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 NE | Dimension measurement displays on a combined image were found inaccurate after the clinician merged multiple image series into one image. | accessdata.fda.gov |
| February 10, 2010 | 54638 | Not yet classified | Terminated | 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 SCANNE | Potential for the CT patient table top to become detached from the carrier due to missing washers. | accessdata.fda.gov |
| June 23, 2008 | 48727 | Not yet classified | Terminated | 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. | accessdata.fda.gov |
| December 17, 2007 | 48657 | Not yet classified | Terminated | 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 | Labeling of patient position on scanned image does not match actual patient orientation. | accessdata.fda.gov |
Compare with other makers
Updated October 11, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.