NEUVIZ 16 MULTI-SLICE CT SCANNER SYSTEM

K092742 · Neusoft Medical Systems Co., Ltd. · JAK · Sep 22, 2009 · Radiology

Device Facts

• Record ID: K092742
• Device Name: NEUVIZ 16 MULTI-SLICE CT SCANNER SYSTEM
• Applicant: Neusoft Medical Systems Co., Ltd.
• Product Code: JAK · Radiology
• Decision Date: Sep 22, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

The NeuViz 16 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 with multislice capability up to 16 slices simultaneously. The acquired X-RAY transmission data is reconstructed by computer into cross-sectional imagers of the body from the same axial plane taken at different angles. The system is suitable for all patients.

Device Story

NeuViz 16 is a multi-slice CT scanner system; utilizes continuously rotating X-ray tube and detector array to acquire transmission data; reconstructs data into cross-sectional images from multiple axial angles; supports up to 16 slices simultaneously. Operated by trained clinical staff in hospital or imaging center settings. Provides cross-sectional anatomical visualization to assist physicians in diagnostic decision-making. Benefits patients through non-invasive internal imaging.

Clinical Evidence

No clinical data provided; substantial equivalence supported by bench testing and technological comparison.

Technological Characteristics

Multi-slice CT scanner; 16-slice capability; continuously rotating X-ray tube and detector array; computer-based image reconstruction; whole-body imaging configuration.

Indications for Use

Indicated for whole body computed tomography imaging in all patient populations.

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.

Submission Summary (Full Text)

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

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#### Public Health Service

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

## SEP 8 2 2009

Neusoft Medical Systems Co., Ltd. % Mr. Tamas Borsai TUV Rheinland of North America, Inc. 12 Commerce Road NEWTOWN CT 06470

Re: K092742

Trade/Device Name: NeuViz 16 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 1, 2009 Received: September 8, 2009

#### Dear Mr. Borsai:

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 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

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for . the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Janine M. Morris

Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Attachment 2 Indications for Use Statement

Page 1 of 1

510(k) Number:

K092742

Device Name: NeuViz 16 Multi-slice CT Scanner System

Indications for Use ::

The NeuViz 16 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 with multislice capability up to 16 slices simultaneously. The acquired X-RAY transmission data is reconstructed by computer into cross-sectional imagers of the body from the same axial plane taken at different angles. The system is suitable for all patients.

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)

Doyce M. Khan

Division of Reproductive, Abdominal, and Radiological D k) Number

Indications for Use Statement