CT-C3000DUAL AND CT-C2800DUAL FAMILY OF DUAL-SLICE CT SCANNER SYSTEMS

K041542 · Neusoft Digital Medical Systems Co., Ltd. · JAK · Jun 17, 2004 · Radiology

Device Facts

• Record ID: K041542
• Device Name: CT-C3000DUAL AND CT-C2800DUAL FAMILY OF DUAL-SLICE CT SCANNER SYSTEMS
• Applicant: Neusoft Digital Medical Systems Co., Ltd.
• Product Code: JAK · Radiology
• Decision Date: Jun 17, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The CT-C3000DUAL and CT-C2800DUAL Family of Dual-slice 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.

Device Story

Whole body X-ray computed tomography scanner; features continuously rotating tube-detector system; multi-slice capability (up to 2 slices simultaneously). Inputs: X-ray transmission data taken at different angles. Processing: High-frequency high-voltage generator produces X-radiation; solid-state detector captures transmission data; computer reconstructs data into 2D and 3D images. Output: 2D and 3D images for filming or electronic storage. Used in clinical settings; operated by trained personnel. Healthcare providers use images for diagnostic review and clinical decision-making. Benefits: Provides cross-sectional anatomical visualization for patient diagnosis.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics and performance standards.

Technological Characteristics

Dual-slice CT scanner; continuously rotating tube-detector system; solid-state detector; high-frequency high-voltage generator. Complies with 21 CFR Subchapter J, UL 187, and IEC60601-1. Software provides interactive scan control, image reconstruction, and archive/evaluation.

Indications for Use

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

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

• CT-C3000 system (K020913)

Submission Summary (Full Text)

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## Attachment 2 Summary of Safety and Effectiveness

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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-C3000DUAL and CT-C2800DUAL Family of Dual-slice CT<br>Scanner Systems |
| 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<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 Systems Co.,Ltd<br>No.3-11,Wenhua Road, Heping District,<br>Shenyang, China<br>Post Code : 110004 |
| Distributor: | Neusoft Digital Medical Systems 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]<br>Summary prepared : Dec 7th, 2003 |

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Image /page/1/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 the overall design is simple and modern. The image is in black and white.

## Safety and Effectiveness information

Intended Uses:

The CT-C3000DUAL and CT-C2800DUAL Family of Dual-slice 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.

Device Description:

The CT-C300DUAL and CT-C2800DUAL Family of Dual-slice CT Scanner Systems are a whole body X-ray computed tomography scanner which features a continuously rotating tube-detector system and multi-slice capability of up to 2 slices simultaneously . The system software is an interactive program used for X-ray scan control, image reconstruction, and image archive/evaluation.

Predicated Device:

CT-C3000 system (K020913)

Statement of Substantial Equivalence:

The CT-C300DUAL and CT-C2800DUAL Family of Dual-slice CT Scanner Systems comparable type and substantially equivalent to the CT-C3000 system are of (K020913) that complies with the same or equivalent standards and has the same intended uses. Both 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 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.

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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the seal is an emblem that appears to be an abstract representation of an eagle or bird-like figure with three stylized wings or feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUN 1 7 2004

Neusoft Digital Medical Systems Co., Ltd. % Mr. Tamas Borsai 76 Mir. Tainas Borbai
510(k) Third Party Review Program Manager Regulation Number: 21 CFR 892.1750 TUV Rheinland of North America 12 Commerce Road NEWTOWN CT 06470

Re: K041542 Trade/Device Name: CT-C3000DUAL and CT-C2800DUA Family of Dual-slice CT Scanner System Regulation Name: Computed tomography x-ray system Regulatory Class: II

Product Code: 90 JAK Dated: June 2, 2004 Received: June 8, 2004

Dear Mr. Borsai:

We have reviewed your Section 510(k) premarket notification of intent to market the device WC nave reviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enatiment date of the Medical Device Amendments, or to conniner of pror to may 20, sifed in accordance with the provisions of the Federal Food, Drug, de necs mat have been require approval of a premarket approval application (PMA), and Cosmetter roll (10) that to nevice, subject to the general controls provisions of the Act. The I ou may, therefore, marries 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 If your device is elassinos (social controls. Existing major regulations affecting your device can may be subjoct to back deegulations, Title 21, Parts 800 to 898. In addition, FDA may oublish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I loase of advisou that I Drimination that your device complies with other requirements of the Act that I DA has made a determination administered by other Federal agencies. You must comply or any 1 our artistics and and including, but not limited to: registration and listing (21 CFR Part with an the Ale Trequirements ( in 2000 manufacturing practice requirements as set forth in the 007); adociding (21 CFR Part 820); and if applicable, the electronic product quality Bybeenins (Sections (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 Section 510(k) I ms letter will anow you to begin manisting of substantial equivalence of your device to a legally premarket notincation. The PPP intemsessification 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 If you desire specific advice for your defit the following numbers, based on the regulation number at the top of the 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 Alountionally, for questions on and 1-639. Also, please note the regulation entitled, "Misbranding Other of Comphanes at (2017 97 - 687.97) you may obtain. Other general by receice to premarket nember the Act may be obtained from the Division of Small miorination on your responsional as assumer 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. Brydon

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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## Indications for Use Attachment 3

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510(k) Number (if known): Ko 41542

CT-C3000DUAL and CT-C2800DUAL Family of Dual-slice CT Scanner Device Name: Systems

Indications for Use:

The CT-C3000DUAL and CT-C2800DUAL Family of Dual-slice CT Scanner Systems are intended to produce cross-section images of head and body by computer reconstruction of X-ray transmission data taken at different angles.

David A. Lymm

(Division Sign-Off Division of Reproductive, Abdomin and Radinlogical Devices 510(k) Number

Prescription Use_ ﺎ

Concurrence of CDRH, Office of Device Evaluation (ODE)