Neusoft Medical Systems Co., Ltd.
Manufacturer and brand owner in Shenyang, Liaoning, China. 1 device type, 5 products catalogued, 23 clearances.
Neusoft Medical Systems Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers System, X-Ray, Tomography, Computed. 5 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2012.
1device type
5products catalogued under its own name
23510(k) clearances
17recalls
Registration
| Registered name | NEUSOFT MEDICAL SYSTEMS CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3003575350 |
| FEI number | 3003575350 |
| DUNS | 724421537 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 东软医疗系统股份有限公司 |
|---|---|
| Unified social credit code | 91210112702087542R |
| Source | NMPA UDI database |
Location
| City | Shenyang |
|---|---|
| Province | Liaoning |
| Address | No.177-1 Chuangxin Road |
| Postal code | 110167 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| System, X-Ray, Tomography, Computed | Class 2 | NeuViz 64 In, NeuViz 64 En, NeuViz 64i,NeuViz 64e, ClearView, NeuViz 16 Essence Multi-Slice CT Scanner System, NeuViz 128 | 2012 | 8 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| NeuViz 64 Multi-slice CT Scanner System | JAK | 4 |
| NeuSight PET/CT Scanner System | JAK | 2 |
| NeuViz 128 Multi-Slice CT Scanner System | JAK | 2 |
| NeuViz Prime Multi-Slice CT Scanner System | JAK | 1 |
| NeuViz 16 Essence Multi-Slice CT Scanner System | JAK | 1 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K230220 | 2023-10-11 | JAK | Traditional | This company |
| K171198 | 2017-12-07 | JAK | Traditional | This company |
| K171201 | 2017-09-13 | JAK | Traditional | This company |
| K151383 | 2015-11-04 | JAK | Traditional | This company |
| K151403 | 2015-11-02 | KPS | Traditional | This company |
| K133373 | 2014-12-03 | JAK | Traditional | This company |
| K121792 | 2012-11-16 | JAK | Traditional | This company |
| K110077 | 2011-01-28 | LLZ | Traditional | This company |
| K102435 | 2010-10-15 | LLZ | Traditional | This company |
| K092742 | 2009-09-22 | JAK | Traditional | This company |
| K092237 | 2009-09-09 | LNH | Traditional | This company |
| K092235 | 2009-08-06 | LLZ | Traditional | This company |
| K090552 | 2009-03-16 | LLZ | Traditional | This company |
| K090173 | 2009-02-05 | JAK | Traditional | This company |
| K083877 | 2009-01-13 | ITX | Traditional | This company |
| K082485 | 2008-09-09 | LNH | Traditional | This company |
| K080540 | 2008-03-13 | JAK | Traditional | This company |
| K072841 | 2007-10-16 | JAK | Traditional | This company |
| K071308 | 2007-08-16 | JAK | Traditional | This company |
| K071154 | 2007-05-10 | LNH | Traditional | This company |
| K062860 | 2006-10-27 | LNH | Special | This company |
| K062451 | 2006-09-28 | JAK | Traditional | This company |
| K061132 | 2006-05-24 | LNH | Special | This company |
Recalls
13 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2018-10-22 | Class II | Software design | 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, r | 6 | 2022-08-25 |
| 2018-10-22 | Class II | Software design | 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, r | 37 | 2022-08-25 |
| 2018-10-22 | Class II | Software design | 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, r | 2 | 2022-08-25 |
| 2017-05-19 | Class II | Software design | Software defect | 234 | 2020-11-19 |
| 2017-05-19 | Class II | Software design | Software defect | 154 | 2020-11-19 |
| 2016-08-31 | Class II | Software design | 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 befo | 23 units | 2018-01-04 |
| 2016-08-31 | Class II | Software design | 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 befo | 23 units | 2018-01-04 |
| 2016-03-24 | Class II | Under Investigation by firm | 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 | 37 units | 2016-11-23 |
| 2015-05-02 | Class II | Device Design | 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 | 7 units | 2016-11-04 |
| 2013-03-04 | Class II | Use error | 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 pane | 25 units | 2013-11-22 |
| 2013-03-04 | Class II | Use error | 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 pane | 23 units | 2013-11-22 |
| 2012-10-18 | Class II | Device Design | 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. | 20 units of NeuViz 16 CT Scanner Systems and 25 units of Neu | 2013-07-08 |
| 2012-06-08 | Class II | Device Design | 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. | 15 units distributed in the US | 2012-09-17 |
| 2011-02-09 | Not classified | Other | Dimension measurement displays on a combined image were found inaccurate after the clinician merged multiple image series into one image. | 9 units distributed in US | 2011-08-24 |
| 2010-02-10 | Not classified | Other | Potential for the CT patient table top to become detached from the carrier due to missing washers. | 26 devices | 2011-04-15 |
| 2008-06-23 | Not classified | Nonconforming Material/Component | 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 | 15 units in US | 2010-09-24 |
| 2007-12-17 | Not classified | Software design | Labeling of patient position on scanned image does not match actual patient orientation. | 15 units | 2012-02-16 |
From the Company
Published by the company on its own website, not by the FDA.
| Main products | CT systems, MRI systems, DSA systems, DR systems, PET/CT systems |
|---|---|
| Certifications | FDA, CE |
| Export markets | 130+ countries and regions |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
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