The NeuViz 128 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.

Device Description

The NeuViz 128 Multi-slice CT Scanner System is composed of a gantry, a patient couch, an operator console and includes image acquisition hardware and software, and associated accessories. It is designed to be a head and whole body X-ray computed tomography scanner which features a continuously rotating tube-detector system and functions according to the fan beam principle.

The system provides the filter back-projection (FBP) and iterative reconstruction algorithm(ClearView cleared in K133373) to reconstruct images. The end user can choose to apply either ClearView or the FBP to the acquired raw data.

The system software is an interactive program used for X-ray scan control, image reconstruction, and image archive/evaluation. It provides the following digital image processing and visualization tools:

Support following scan speed:0.374s、0.5s、0.6s、0.8s、1.0s、1.5s、2.0s.
· Surview scan
· Dual surview
o Spiral scan
o Axial scan
Image reconstruction
Plan scan
Patient information management
Patient information reqistration
O Protocol selection
Bolus Tracking
CCT scan
. Cardiac scan
Multi-phase scan
O Tube Warm-up
Film
Report
O 2D
DICOM Viewer O
O MPR
0 3D
Virtual Endoscopy
. Dental
Vessel Analysis
Virtual Colonoscopy
Brain Perfusion
· Body Perfusion
Lung Nodule Analysis
Lung Density Analysis
Coronary Analysis
Cardiac Calcium Scoring
Cardiac Function Analysis
Cardiac Viewer
Fat Analysis
CTDSA
Tumor Assessment

AI/ML Overview

The provided text describes the NeuViz 128 Multi-Slice CT Scanner System (K151383), and its substantial equivalence claims against predicate devices. However, it does not contain detailed acceptance criteria for a specific device performance, nor does it present a study that explicitly details the device meeting such criteria with specific metrics.

The document focuses on non-clinical testing for compliance with various standards (electrical safety, EMC, radiation protection, usability, software lifecycle, risk management, DICOM) and states that "Verification and validation activities (including performance testing, safety testing and simulated use testing) are performed" and "The results of these tests demonstrate that the subject device performs as intended." It also mentions "Sample clinical images were provided within the submission. The image quality has been evaluated in bind state by two certified radiologists."

Therefore, based on the provided text, I cannot complete a table of acceptance criteria and reported device performance, nor fully answer all aspects of your request, as the specific performance metrics and detailed study results are not present.

However, I can extract the available information:

1. A table of acceptance criteria and the reported device performance:

This information is not explicitly provided in the document. The text states that the device adheres to various international and national standards (listed in the "Nonclinical Testing" section) and that "Verification and validation activities... are performed" and "The results of these tests demonstrate that the subject device performs as intended." However, specific numerical acceptance criteria (e.g., spatial resolution > X lp/cm, contrast resolution > Y HU) and corresponding reported performance values for the NeuViz 128 are not detailed.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Test Set Sample Size: "Sample clinical images were provided within the submission." The exact number of images or cases is not specified.
Data Provenance: The country of origin and whether the data was retrospective or prospective are not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Number of Experts: "two certified radiologists."
Qualifications of Experts: They are described as "certified radiologists." Further details on their experience level are not specified.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

The term "adjudication method" is not explicitly mentioned. The document states that image quality was "evaluated in bind state by two certified radiologists," implying a consensus or independent review process, but the specific method (e.g., if one disagreed, what was the next step) is not detailed.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

MRMC Study: An MRMC comparative effectiveness study, particularly one comparing human readers with and without AI assistance, is not described or mentioned in the provided text. The device is a CT scanner, not an AI-powered diagnostic tool explicitly designed to assist human readers in a comparative effectiveness study as described.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

The document describes the NeuViz 128 as a CT scanner system that performs image acquisition and reconstruction. While it has advanced image processing and visualization tools (e.g., "ClearView" iterative reconstruction, "Lung Nodule Analysis," "Cardiac Function Analysis"), the submission focuses on its performance as an imaging device. A "standalone" performance evaluation in the context of an algorithm replacing human interpretation is not explicitly described. The evaluation mentioned is of "image quality" evaluated by radiologists, suggesting human interpretation of the images produced by the device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

The "ground truth" for the image quality evaluation appears to be the expert opinion/assessment of the two certified radiologists on the "sample clinical images." No mention of pathology, outcomes data, or other objective ground truths is included.

8. The sample size for the training set:

Training Set Sample Size: The document does not mention a training set sample size. The device is a CT scanner, and while it uses algorithms for image reconstruction and analysis, the details of any machine learning training data are not provided in this 510(k) summary.

9. How the ground truth for the training set was established:

Ground Truth for Training Set: Since a training set is not mentioned, how its ground truth was established is also not provided.

Summary

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Image /page/0/Picture/1 description: The image is a circular seal for the U.S. Department of Health & Human Services. The seal features the department's name in a circular arrangement around the perimeter. In the center is the department's logo, which consists of a stylized caduceus symbol with three intertwined figures representing people.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 4, 2015

Neusoft Medical Systems Co., Ltd. % Tian Yuehui Manager of Q&R Department No.16, Shiji Road, Hunnan Industrial Area Shenyang, Liaoning 110179 CHINA

Re: K151383

Trade/Device Name: NeuViz 128 Multi-Slice CT Scanner System Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: September 17, 2015 Received: September 21, 2015

Dear Tian Yuehui:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Robert Ochs

Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K151383

Device Name

NeuViz 128 Multi-Slice CT Scanner System

Type of Use (Select one or both, as applicable)

Indications for Use (Describe)

X Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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510(K) Summary

This 510(k) summary of Safety and Effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.92

General Information:

Trade Name:	NeuViz 128
Common Name:	CT Scanner
CFR Section:	21 CFR 892.1750
Classification Name:	Computed tomography x-ray system
Product Code:	JAK
Classification:	Class II
Performance Standard:	21 CFR Subchapter J, Federal Diagnostic X-ray EquipmentStandard
Manufacturer:	Neusoft Medical Systems Co., Ltd.No.16 Shiji Road, Hunnan Industrial Area, Shenyang,Liaoning, 110179, China.
Submitter:	Contact : Tian YuehuiTitle : Manager of Q&R DepartmentTel : 86-24-83660646Fax : 86-24-83660563E-Mail : tianyh@neusoft.com

Summary prepared :September 16, 2015

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Safety and Effectiveness information

Indications for use:

Device Description:

Support following scan speed:0.374s、0.5s、0.6s、0.8s、1.0s、1.5s、2.0s.
· Surview scan
· Dual surview
o Spiral scan
o Axial scan
Image reconstruction
Plan scan
Patient information management
Patient information reqistration
O Protocol selection
Bolus Tracking
CCT scan
. Cardiac scan
Multi-phase scan
O Tube Warm-up
Film
Report
O 2D
DICOM Viewer O
O Home
O MPR
0 3D
Virtual Endoscopy
. Dental
Vessel Analysis
Virtual Colonoscopy
Brain Perfusion
· Body Perfusion
Lung Nodule Analysis

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Neusoft

Lung Density Analysis
Coronary Analysis
Cardiac Calcium Scoring
Cardiac Function Analysis
Cardiac Viewer
Fat Analysis
CTDSA
Tumor Assessment

Predicated Device:

Philips Ingenuity Core128 CT System(K033326)

Reference Device

NeuViz 64e CT system (K121792).

Statement of Substantial Equivalence:

The NeuViz 128 Multi-slice CT Scanner System has the same indications for use as the predicate device, "Philips Ingenuity Core128" CT Scanner (K033326). The "NeuViz 128" is a computed Tomography X-Ray System intended to produce images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. The subject device does not have significant changes in technological characteristics when compared to the predicate device. The subject device and predicate device are the same in regards to:

Detector/Tube system that can rotate continuously. The Tube emits X-ray beam 0 of fan shape, detector system with multiple channels;
Low voltage slip ring and On-Board HV Generator; ●
0 Parallel data acquisition, simultaneous scan and image reconstruction;
Gantry that may be tilted forward or backward;
Patient Couch that can be elevated or lowered;
0 Computerized control of scan and other operations;
0 Computerized image reconstruction and post processing;
0 Digitarized display, storage and output of data/image.

The subject device and the reference device, "NeuViz 64e" CT Scanner (K121792) are the same in regard to most of application features.

A complete comparison table is included in this submission. The following table shows a brief comparison of the application features, including both similarities and differences among the subject, the predicate and the reference devices.

NeuViz 128	Ingenuity Core128	NeuViz 64e
O-Dose	√	√
Networking	√	√
Bolus tracking	√	√
SAS	√	√

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Home	✓	✓
Filming	✓	✓
Report	✓	✓
Image Review	✓	✓
MPR	✓	✓
3D	✓	✓
VE(Virtual Endoscopy)	✓	✓
Vessel Analysis	✓	✓
Dicom Viewer	✓	✓
Barcode Reader	✓	✓
Dual Monitor	✓	✓
Continuous CT	✓	✓
ClearView	✓	✓
iHD	✓	X
Cardiac Scan	✓	✓
Dental Analysis	✓	✓
Virtual Colonoscopy	✓	✓
Brain Perfusion	✓	✓
Body Perfusion	✓	✓
Lung Nodule Analysis	✓	✓
Lung Density	✓	✓
Coronary Analysis	✓	✓
Cardiac Calcium Scoring	✓	✓
Cardiac Function Analysis	✓	✓
Cardiac Viewer	✓	X
Fat Analysis	X	X
Nerve System DSA	X	✓
Tumor Assessment	X	✓
Preprocessing function	✓	X
Comparison

" √ " symbol means the comparable type and substantially equivalent to the contrasted devices.

"x" symbol means the new clinical functionality.

But the main algorithm of Fat Analysis Application is segmenting the contour of subcutaneous and visceral, and calculating the area of subcutaneous and visceral according to the result of segmentation. Additionally, the segmentation method is similar to the Contour Segmentation function in 3D Application, and the calculation method is similar to the ROI's area calculation in Common Tool. Verification and validation testing supports this application.

According to the comparison based on the requirements of 21 CFR 807.87, we stated that these devices are substantially equivalent.

Nonclinical Testing:

The safety and effectiveness of the NeuViz 128 was assured by adherence to Good Manufacturing Practices(GMP) 21CFR 820 and to International Standards ISO 13485:2003. This device is in conformance with the applicable parts of the following standards:

ANSI/AAMI ES60601-1:2005/(R) 2012 and A1:2012, C1:2009/(R)2012 and o A2:2010/(R)2012 medical electrical equipment -- part 1: general requirements for basic safety and essential performance

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Neusoft

0 IEC 60601-1-2: 2007, Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
IEC 60601-1-3: 2008, Medical electrical equipment -- Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
IEC 60601-1-6: 2013, Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
IEC 60601-2-28: 2010, Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis
0 IEC 60601-2-44:2009, Medical Electrical Equipment - Part 2-44: Particular Requirements For The Basic Safety And Essential Performance Of X-Ray Equipment For Computed Tomography
IEC 60825-1:2007, Safety of laser products - part 1: equipment classification, and requirements
0 IEC 61223-3-5: 2004, Evaluation and routine testing in medical imaging departments - Part 3-5: Acceptance tests - Imaging performance of computed tomography X-ray equipment
0 IEC 62304:2006, Medical device software - Software life-cycle processes
0 IEC 62366:2014,Medical Devices - Application Of Usability Engineering To Medical Devices
0 ISO 10993-1: 2009, Biological evaluation of medical devices - part 1: evaluation and testing within a risk management process.
0 ISO 14971:2007, Medical devices – Application of risk management to medical devices
O NEMA PS 3.1 - 3.20: 2011, Digital Imaging and Communications in Medicine (DICOM)
0 NEMA XR 25: 2010, Computed tomography dose check
0 NEMA XR 28: 2013, Supplemental Requirements for User Information and System Function Related to Dose in CT

Additionally, this device complies with all applicable requirements of the radiation safety performance standards, as outlined in 21 CFR §1010 and §1020.

Risk management is ensured via a hazard analysis which is used to identify potential hazards. These potential hazards are controlled during product development, and verification and validation testing. To minimize electrical, mechanical, and radiation hazards, Neusoft adheres to recognized and established industry practice and standards.

Software safety is assured by the company procedures that conform to accepted practices. Quality assurance procedures are adhered to, and meeting the specifications and functional requirements if demonstrated via testing. Software Documentation for a Moderate Level of Concern, per the FDA guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Document" issued on May 11, 2005, is also included as part of this submission.

Verification and validation activities(including performance testing, safety testing and simulated use testing) are performed. The results of these tests demonstrate that the subject device performs as intended. The result of all conducted testing was found acceptable to support the claim of substantial equivalence.

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clinical Testing:

Sample clinical images were provided within the submission. The image quality has been evaluated in bind state by two certified radiologists.

Conclusions:

According to the comparison based on the requirements of 21.CFR 807.87, We state that the candidate device and the predicate device are substantially equivalent.

Regulation Number and Section

§ 892.1750 Computed tomography x-ray system.

(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.