CT-C3000 SPIRAL CT SCANNER SYSTEM

K020913 · Neusoft Digital Medical Systems Co., Ltd. · JAK · Apr 3, 2002 · Radiology

Device Facts

• Record ID: K020913
• Device Name: CT-C3000 SPIRAL CT SCANNER SYSTEM
• Applicant: Neusoft Digital Medical Systems Co., Ltd.
• Product Code: JAK · Radiology
• Decision Date: Apr 3, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

CT-C3000 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

CT-C3000 Spiral CT Scanner System; acquires X-ray transmission data at multiple angles; performs computer reconstruction to generate cross-sectional images of head and whole body. Operated by trained medical professionals in clinical settings. Output used by physicians for diagnostic imaging and clinical decision-making. Benefits include non-invasive visualization of internal anatomy for diagnostic purposes.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and adherence to established performance standards for diagnostic X-ray equipment.

Technological Characteristics

Spiral CT scanner system; X-ray source; detector array for transmission data acquisition; computer reconstruction hardware/software. Complies with 21 CFR Subchapter J (Federal Diagnostic X-ray Equipment Standard), UL 187, and IEC 60601-1. Class II device.

Indications for Use

Indicated for head and whole-body cross-sectional imaging via X-ray transmission data reconstruction. Intended for prescription use.

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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## Attachment 2

K 020913

# 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:

| Trade Name: | CT-C3000 Spiral 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 Standard<br>UL 187, Standard for safety, X-ray Equipment<br>IEC60601-1, Medical Electrical Equipment - Part 1: General<br>Requirements for Safety |
| Manufacture: | Neusoft Digital Medical System Co.,Ltd<br>No.3-11,Wenhua Road, Heping District,<br>Shenyang, China<br>Post Code : 110004 |
| Distributor: | Neusoft Digital Medical System Co.,Ltd<br>No.3-11, Wenhua Road, Heping District,<br>Shenyang, China<br>Post Code : 110004 |
| Submitter: | Name: Wang Zhiqiang<br>Title: Manager of Quality Management Department<br>Who maybe contacted<br>by telephone at 86-24-83665003<br>by FAX at 86-24-23782711<br>by E-Mail at [e-mail] |
| | Summary prepared : Mar 9th , 2002 |

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

### APR 0 3 2002

Neusoft Digital Medical System Co. % Mr. Wolfram Gmelin Technical Manager TÜV Rheinland of North America 12 Commerce Road NEWTOWN CT 06470

Re: K020913

Trade/Device Name: CT C3000 Spiral CT Scan System Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: 90 JAK Dated: March 18, 2002 Received: March 21, 2002

Dear Mr. Gmelin:

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); 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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This letter will allow you to begin marketing your device as described in your 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 Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.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

Enclosure

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Image /page/3/Picture/0 description: The image shows the word "NEUSOFT" in bold, black letters. There is a curved line above the word, which appears to be part of a logo. The font is sans-serif and slightly italicized, giving the word a dynamic appearance. The overall impression is of a company logo or brand name.

510(k)

Attachment 3

Indications for Use

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510(k) Number (if Known) K020913

Device Name: CT-C3000 System

Indications for use:

CT-C3000 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.

David G. Seymour

(Division Sign-Off) Division of Reproductive, and Radiological Devi 510(k) Numb

Prescription Use (Per 21 CFR 801.109)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)