NEUSOFT SPIRAL CT SCANNER SYSTEM, MODEL NEUVIZ VERSION 2.0

K080540 · Neusoft Medical Systems Co., Ltd. · JAK · Mar 13, 2008 · Radiology

Device Facts

• Record ID: K080540
• Device Name: NEUSOFT SPIRAL CT SCANNER SYSTEM, MODEL NEUVIZ VERSION 2.0
• Applicant: Neusoft Medical Systems Co., Ltd.
• Product Code: JAK · Radiology
• Decision Date: Mar 13, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The NeuViz Spiral CT Scanner System is 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 Spiral CT Scanner System; head and whole body X-ray computed tomography scanner. Features continuously rotating tube-detector system; operates on fan beam principle. Inputs: X-ray transmission data acquired at different angles. Processing: computer reconstruction of transmission data. Outputs: 2D and 3D images for clinical review, filming, or electronic storage. Used in clinical settings; operated by trained healthcare professionals. System includes gantry, patient couch, operator console, acquisition hardware, and software for scan control, reconstruction, and image archive/evaluation. High-frequency high-voltage generator produces X-radiation. Facilitates diagnostic imaging for clinical decision-making.

Clinical Evidence

No clinical tests conducted. Substantial equivalence supported by non-clinical performance, biocompatibility, electrical, mechanical, chemical, biological, and radiation safety testing.

Technological Characteristics

Computed tomography X-ray system; fan beam principle; continuously rotating tube-detector system; high-frequency high-voltage generator; solid-state detector; interactive software for scan control, reconstruction, and archiving. Conforms to 21 CFR Subchapter J (Federal Diagnostic X-ray Equipment Standard).

Indications for Use

Indicated for head and whole body cross-sectional imaging via computer reconstruction of X-ray transmission data. Prescription use only.

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 Multi-slice CT Scanner System (K071308)

Submission Summary (Full Text)

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Ko 80 540
\$_{510(k)}\$

## Attachment 1 Summary of Safety and Effectiveness

Page 1 of 2

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:

| | | MAR 13 2008 |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Trade Name:<br>Common Name: | NeuViz Spiral CT Scanner System<br>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 | |
| Manufacture: | PHILIPS AND NEUSOFT MEDICAL SYSTEMS CO., LTD.<br>Neusoft Park, Hun Nan Industrial Area, Shenyang 110179,<br>P.R.China | |
| Distributor: | NEUSOFT MEDICAL SYSTEMS CO., LTD.<br>No.3-11,Wenhua Road, Heping District,<br>Shenyang, P.R.China<br>Post Code : 110004 | |
| Submitter: | Contact : Tianyanfang<br>Title : Manager of Q&R Department<br>Tel : [phone]<br>Fax : [phone]<br>E-Mail : [e-mail] | |

Summary prepared :Dec. 28, 2007

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#### Page 2 of 2

### Safety and Effectiveness information

Intended Uses:

The NeuViz Spiral CT Scanner System is 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 Spiral 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 software is an interactive program used for X-ray scan control, image reconstruction, and image archive/evaluation.

The NeuViz Spiral CT Scanner System uses the same materials, construction and operating principle as our existing marketed product, NeuViz Dual Multi-slice CT Scanner System.

Predicated Device:

NeuViz Dual Multi-slice CT Scanner System (K071308)

Statement of Substantial Equivalence:

The NeuViz Spiral CT Scanner System is of comparable type and substantially equivalent to the NeuViz Dual Multi-slice CT Scanner System (K071308) that complies with the same or equivalent standards and has the same intended uses. Both of these systems 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 solid-state detector and is reconstructed by the computer which has an interactive user interface. Both of these devices produce two dimensional image and 3D image that can be filmed or electronically stored for future review.

a. Non-clinical tests: The device has been evaluated for performance, biocompatibility and effectiveness as well as electdical , mechanical, chemical, biological, and radiation safety and has been found to substantially equivalent to predicate device. The design and development process of the manufacturer conforms to 21 CFR part 820, ISO 9001 and ISO 13485 quality systems. b. Clinical tests: No clinical tests conducted.

c. Conclusion: The device was evaluated against the predicate device (NeuViz Dual Multi-slice CT Scanner System (K071308)) for all performance, safety & effectiveness requirements and found as substantially equivalent to the predicate device.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# MAR 1 3 2008

Neusoft Medical Systems Co., Inc. c/o TUV Rheinland of North America 12 Commerce Rd. Newton, CT 06470

Re: K080540

Trade/Device Name: Neusoft Spiral CT Scanner System (Modified) V2.0 (Model NeuViz) Regulation Number: 21 CFR 1750 Regulation Name: Computed tomography x-ray system Regulatory Class:. Class II Product Code: JAK Dated: February 25, 2008 Received: February 27, 2008

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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.

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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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for 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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrh/industry/support/index.html.

Sincerely yours.

Nancy C. Brogdon

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

nclosure

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510(k)

## Attachment 2 Indications for Use Statement

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1080540 510(k) Number:

Device Name: NeuViz Spiral CT Scanner System

Environment of Use / Patient Population:

The NeuViz Spiral CT Scanner Systems are intended to produce cross-section images of head and whole 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 (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)

Toni Mitha

Division of Reproductive. Abdominal and Radiological De 510(k) Number

Indications for Use Statement