MODIFICATION TO NEUVIZ DUAL MULTI-SLICE CT SCANNER SYSTEM

K071308 · Neusoft Medical Systems Co., Ltd. · JAK · Aug 16, 2007 · Radiology

Device Facts

• Record ID: K071308
• Device Name: MODIFICATION TO NEUVIZ DUAL MULTI-SLICE CT SCANNER SYSTEM
• Applicant: Neusoft Medical Systems Co., Ltd.
• Product Code: JAK · Radiology
• Decision Date: Aug 16, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2

Intended Use

The NeuViz Dual Systems (modified) are intended to produce cross-section images of head and whole body by computer reconstruction of X-ray transmission data taken at different angles.

Device Story

NeuViz Dual Multi-slice CT Scanner System; whole-body X-ray computed tomography scanner. Features continuously rotating tube-detector system; multi-slice capability (2 slices simultaneously). Inputs: X-ray transmission data taken at different angles. Transformation: High-frequency high-voltage generator produces X-radiation; detector captures transmission data; computer performs image reconstruction. Outputs: 2D and 3D cross-sectional images for electronic storage or filming. Used in clinical settings; operated by trained medical professionals. Healthcare providers use output for diagnostic review and clinical decision-making. Benefits: Enables non-invasive visualization of internal anatomy for diagnostic assessment.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Multi-slice CT scanner (2 slices). High-frequency high-voltage generator. Rotating tube-detector system. Connectivity: Interactive user interface for scan control, reconstruction, and archive. Standards: IEC/EN 60601-1, 60601-1-1, 60601-1-2, 60601-1-3, 60601-1-4, 60601-2-28, 60601-2-32, 60601-2-44.

Indications for Use

Indicated for producing cross-sectional images of the head and whole body via computer reconstruction of X-ray transmission data for diagnostic purposes.

Regulatory Classification

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.

Predicate Devices

• NeuViz Dual Systems (K062451)
• Philips Plus CT Scanner (K033326)

Submission Summary (Full Text)

{0}------------------------------------------------

# Neusoft

510(k) K071308

# Attachment 1

AUG 16 2007

## Summary of Safety and Effectiveness

Page 1 of 3

This 510(k) summary of Safety and Effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.87(h)

General Information:

| Trade Name: | NeuViz Dual Multi-slice CT Scanner System |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | CT Scanner |
| Classification Name: | 21 CFR Part 892.1750<br>Computed Tomography X-ray System |
| Classification: | Class II |
| Performance Standard: | 21 CFR Subchapter J, Federal Diagnostic X-ray Equipment<br>Standard |
| | IEC/EN 60601-1, Medical Electrical Equipment - Part 1:<br>General Requirements for Safety |
| | IEC/EN 60601-1-1, Medical electrical equipment--Part<br>1:General requirements for safety-1. Collateral Standard:<br>Safety requirements for medical electrical systems |
| | IEC/EN 60601-1-2, Medical electrical equipment--Part<br>1:General requirements for safety-2. Collateral Standard:<br>Electromagnetic compatibility-Requirements and tests |
| | IEC/EN 60601-1-3, Medical electrical equipment--Part<br>1:General requirements for safety-3. Collateral Standard:<br>General requirements for radiation protection in diagnostic<br>X-ray equipment |

{1}------------------------------------------------

IEC/EN 60601-1-4, Medical electrical equipment-Part 1:General requirements for safety-4. Collateral Standard: Programmable electrical medical systems

IEC/EN 60601-2-28, Medical electrical equipment--- Part 2:Particular requirements for the safety of X-ray source assemblies and X-ray tube assemblies for medical diagnosis

IEC/EN 60601-2-32, Medical electrical equipment--- Part 2:Particular requirements for the safety of associated equipment of X-ray equipment

IEC/EN 60601-2-44, Medical electrical equipment--- Part 2:Particular requirements for the safety of X-ray equipment for computed tomography

Page 2 of 3

| Manufacture: | PHILIPS AND NEUSOFT MEDICAL SYSTEMS CO., LTD.<br>Neusoft Park, Hun Nan Industrial Area, Shenyang 110179<br>P.R.China |
|--------------|----------------------------------------------------------------------------------------------------------------------|
|--------------|----------------------------------------------------------------------------------------------------------------------|

NEUSOFT MEDICAL SYSTEMS CO., LTD. Distributor: No.3-11,Wenhua Road, Heping District, Shenyang, P.R.China Post Code : 110004

Submitter: Contact : Tianyanfang Title : Manager of Q&R Department Tel : [phone] Fax : [phone] E-Mail : [e-mail]

Summary prepared : May 19th, 2006

{2}------------------------------------------------

#### Page 3 of 3

#### Safety and Effectiveness information

Intended Uses:

The NeuViz Dual Systems (modified) are intended to produce cross-section images of head and whole body by computer reconstruction of X-ray transmission data taken at different angles.

Device Description:

The NeuViz Dual Systems (modified) are whole body X-ray computed tomography scanner which features a continuously rotating tube-detector system and multi-slice capability of 2 slices simultaneously. The system software is an interactive program used for X-ray scan control, image reconstruction, and image archive/evaluation.

Predicated Device:

K062451: NeuViz Dual Systems K033326: Philips Plus CT Scanner

Statement of Substantial Equivalence:

The NeuViz Dual (modified) systems are of comparable type and substantially equivalent to the NeuViz Dual system (K062451) and the "Philips Plus" CT Scanner (K033326) that comply with the same or equivalent standards and have the same intended uses. All of these system use on-board high frequency High-Voltage generator to generate X-radiation from X-ray tube. The X-ray transmission data is detected by the detector and is reconstructed by the computer which has an interactive user interface. All of these devices produce two dimensional image and 3D image that can be filmed or electronically stored for future review.

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows a circular logo. The logo contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is a stylized image of an eagle.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Mr. Tian Yanfang Manager of Quality Management Department NEUSOFT Medical Systems Co., Ltd. No. 3-11, Wenhua Road, Heping District Shenyang, Liaoning 110004 P. R. CHINA

AUG 16 2007

Re: K071308

Trade/Device Name: NeuViz Dual 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: July 11, 2007 Received: August 9, 2007

#### Dear Mr. Yanfang:

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 coaminer ro 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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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.

Image /page/3/Picture/10 description: The image shows a circular logo with the text "1876-1976" at the top. Below the text is the abbreviation "PA" in large, bold letters. Underneath "PA" is the word "Centennial" in a cursive font. There are four stars at the bottom of the logo. The logo is surrounded by a dotted circle.

lating and Promoting Public Ha

{4}------------------------------------------------

Page 2 -

Please be advised that FDA's issuance of a substantial equivalence determination does not mean i that FDA has made a determination that your device complies with other requirements of the Act that I Drives made a and regulations administered by other Federal agencies. You must or any I oditar bakated is requirements, including, but not limited to: registration and listing (21 Comply with an the Hot 811 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic ford in all quality by crossions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter with anow you'ls cognituding of substantial equivalence of your device to a legally premaints in a classification for your device and thus, permits your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please n you done office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone]

or at its Internet address http://www.fda.gov/cdrlv/industry/support/index.html.

Sincerely yours,

Nancy Chogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

### Attachment 2

### Indications for Use

510(k) Number:

K071308

Device Name: NeuViz Dual Multi-slice CT Scanner System

The NeuViz Dual Systems (modified) are intended to produce cross-section images of head and body by computer reconstruction of X-ray transmission data taken at different angles.

Prescription Use YES (Part 21 CFR 801 Subpart D) Over-The-Counter Use NO

(Part 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF DEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

JWhang

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

Page 1 of 1

Indications for Use Statement