NeuViz 128 Multi-Slice CT Scanner System
NeuViz 128 is a whole body X-ray CT scanner that produces cross sectional images from transmission measurements acquired around the patient. It combines a gantry, patient couch, operator…
NeuViz 128 is a whole body X-ray CT scanner that produces cross sectional images from transmission measurements acquired around the patient. It combines a gantry, patient couch, operator console and image acquisition and reconstruction hardware and software.
An X-ray tube and detector array rotate continuously around the patient using fan beam geometry. The computer reconstructs images from measurements taken at different angles during axial or spiral scanning. A 64 row detector supports generation of up to 128 slices per rotation.
Image Reconstruction
The scanner provides filtered back projection and ClearView iterative reconstruction. Optional ClearInfinity reconstruction uses a trained neural network for image noise reduction. The gantry has a 72 cm opening and a standard reconstruction field of view up to 50 cm.
8manufacturers in China registered for this device type
2catalogue numbers in this listing
12510(k) clearances naming this product code
17recalls on this code
Who Else Makes It
Concentrated in Beijing (2), Shanghai (2), Jiangsu (2). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Philips Healthcare (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 5 |
| Qisda Electronics (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 5 |
| GE Hangwei Medical Systems Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| GE Healthcare (China) Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| Shanghai United Imaging Healthcare Co., Ltd. | Shanghai | Shanghai | Manufacturer | 12 |
| Siemens Shanghai, Medical Equipment Ltd. | Shanghai | Shanghai | Contract manufacturer | 10 |
| Neusoft Medical Systems Co., Ltd. | Shenyang | Liaoning | Manufacturer | 1 |
| Philips Health Technology (China) Co., Ltd. Shenyang Branch | Shenyang | Liaoning | Specification developer | 1 |
Record
| Listed by | Neusoft Medical Systems Co., Ltd., China |
|---|---|
| FDA product code | JAK |
| Device type | System, X-Ray, Tomography, Computed |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1750 |
| Establishment | Manufacturer |
| 510(k) | K230220 |
| Record published | 2023-10-23 |
| Record revised | 2023-06-29 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| NeuViz 128 | In distribution | |
| NeuViz 128 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Visicoil | IZI Medical Products LLC | 48 |
| Visicoil MR | IZI Medical Products LLC | 41 |
| Illumisite | Covidien LP | 25 |
| Imbio LDA | Imbio, LLC | 24 |
| Edge | Covidien LP | 20 |
| Revolution | GE Hangwei Medical Systems Co., Ltd. | 20 |
| Gold Fiducial | IZI Medical Products LLC | 20 |
| superDimension | Covidien LP | 17 |
| Lodox | Lodox Systems (PTY) Ltd. | 12 |
| Revolution | GE Medical Systems, L.L.C. | 12 |
| Toshiba Scanner | Canon Inc. | 10 |
| syngo.CT Dual Energy | Siemens Healthcare Limited | 7 |
Showing 12 of 495. All products under System, X-Ray, Tomography, Computed
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K230220 | 2023-10-11 |
| K171198 | 2017-12-07 |
| K171201 | 2017-09-13 |
| K151383 | 2015-11-04 |
| K133373 | 2014-12-03 |
| K121792 | 2012-11-16 |
| K092742 | 2009-09-22 |
| K090173 | 2009-02-05 |
| K080540 | 2008-03-13 |
| K072841 | 2007-10-16 |
| K071308 | 2007-08-16 |
| K062451 | 2006-09-28 |
Recalls Naming This Product
3 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Neusoft Medical Systems IMP & EX | 510(k) number | 2019-01-09 | Class II | Software design | For surview scan length more than 500mm,if the user aborts or skips the reconstructed surview, the image may have the wrong field of view (FOV). When user plans and performs subsequent clinical scan with the wrong FOV the actual start and | 3 | 2022-08-25 |
| Neusoft Medical Systems Co., Ltd. | 510(k) number | 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 |
| Neusoft Medical Systems Co., Ltd. | 510(k) number | 2017-05-19 | Class II | Software design | Software defect | 154 | 2020-11-19 |
Recalls
11 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 | 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 |
| 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 |
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.