K Number
K151383
Device Name
NeuViz 128 Multi-slice CT Scanner System
Date Cleared
2015-11-04

(166 days)

Product Code
Regulation Number
892.1750
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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
More Information

No
The summary describes standard CT image reconstruction (FBP and iterative reconstruction) and image processing tools, but does not mention any AI or ML capabilities.

No

This device is a diagnostic imaging system (CT scanner) used to create images for medical evaluation, not to treat a disease or condition.

Yes

Explanation: The "Intended Use / Indications for Use" states that the NeuViz 128 "can be used as a whole body computed tomography X-ray system," and the "Device Description" details its use for "image acquisition hardware and software, and associated accessories...head and whole body X-ray computed tomography scanner." Furthermore, the device provides various "digital image processing and visualization tools" for "patient information management," "image reconstruction," and specific analyses like "Cardiac Calcium Scoring," "Lung Nodule Analysis," and "Vessel Analysis," which are all functions typically associated with diagnostic imaging. The "Summary of Performance Studies" also references "Radiation protection in diagnostic X-ray equipment" standards.

No

The device description explicitly states that the system is composed of hardware components including a gantry, patient couch, operator console, and image acquisition hardware, in addition to software.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use/Indications for Use: The intended use clearly states it's a "whole body computed tomography X-ray system" used to acquire and reconstruct images of the body using X-ray transmission data. This describes an imaging device, not a device used to examine specimens derived from the human body.
  • Device Description: The description details the physical components of a CT scanner (gantry, couch, console) and its function in acquiring and processing X-ray data to create images. This aligns with an imaging device.
  • Mentions image processing: While it mentions image processing, this is in the context of processing the acquired X-ray data to form diagnostic images, not processing biological samples.
  • Input Imaging Modality: The input is "Computed tomography X-ray," which is an imaging modality, not a biological sample.
  • Performance Studies: The performance studies focus on the safety and effectiveness of the CT system itself, adherence to standards for medical electrical equipment and radiation safety, and evaluation of image quality by radiologists. There are no studies related to the analysis of biological specimens.

IVD devices are specifically designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This CT scanner does not perform such analysis.

N/A

Intended Use / Indications for Use

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.

Product codes

JAK

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
  • Spiral scan
  • Axial scan
  • Image reconstruction
  • Plan scan
  • Patient information management
  • Patient information reqistration
  • Protocol selection
  • Bolus Tracking
  • CCT scan
  • Cardiac scan
  • Multi-phase scan
  • Tube Warm-up
  • Film
  • Report
  • 2D
  • DICOM Viewer
  • Home
  • MPR
  • 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

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

X-Ray Computed Tomography

Anatomical Site

whole body

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

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

Key Metrics

Not Found

Predicate Device(s)

K033326

Reference Device(s)

K121792

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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.

0

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.

1

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

2

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)

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.

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."

3

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 Equipment
Standard
Manufacturer:Neusoft Medical Systems Co., Ltd.
No.16 Shiji Road, Hunnan Industrial Area, Shenyang,
Liaoning, 110179, China.
Submitter:Contact : Tian Yuehui
Title : Manager of Q&R Department
Tel : 86-24-83660646
Fax : 86-24-83660563
E-Mail : tianyh@neusoft.com

Summary prepared :September 16, 2015

4

Safety and Effectiveness information

Indications for use:

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 Home
  • O MPR
  • 0 3D
  • Virtual Endoscopy
  • . Dental
  • Vessel Analysis
  • Virtual Colonoscopy
  • Brain Perfusion
  • · Body Perfusion
  • Lung Nodule Analysis

5

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 128Ingenuity Core128NeuViz 64e
O-Dose
Networking
Bolus tracking
SAS

6

Home
Filming
Report
Image Review
MPR
3D
VE(Virtual Endoscopy)
Vessel Analysis
Dicom Viewer
Barcode Reader
Dual Monitor
Continuous CT
ClearView
iHDX
Cardiac Scan
Dental Analysis
Virtual Colonoscopy
Brain Perfusion
Body Perfusion
Lung Nodule Analysis
Lung Density
Coronary Analysis
Cardiac Calcium Scoring
Cardiac Function Analysis
Cardiac ViewerX
Fat AnalysisXX
Nerve System DSAX
Tumor AssessmentX
Preprocessing functionX
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

7

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.

8

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.