WV3000T DIGITAL X-RAY DIRECT IMAGING FLAT PANEL DETECTOR SYSTEM

K110801 · Direct Digital Imaging Technology (Beijing), Inc. · MQB · Aug 2, 2011 · Radiology

Device Facts

• Record ID: K110801
• Device Name: WV3000T DIGITAL X-RAY DIRECT IMAGING FLAT PANEL DETECTOR SYSTEM
• Applicant: Direct Digital Imaging Technology (Beijing), Inc.
• Product Code: MQB · Radiology
• Decision Date: Aug 2, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1680
• Device Class: Class 2

Intended Use

The 3000T Digital X-ray Direct Imaging Flat Panel Detector System provides a digital image capture capability for conventional radiographic examinations (excluding fluoroscopic, angiographic, and mammographic applications). The device has application wherever conventional screen-film systems are currently used.

Device Story

WV3000T Digital X-ray Direct Imaging Flat Panel Detector System captures and converts conventional projection X-rays into digital images. System components include a detector array, multi-box for exposure synchronization with high-voltage generators, and a system controller (PC-based software). Detector array captures diagnostic images in electronic form; multi-box harmonizes array and generator; system controller manages patient demographics, exposure initiation, image preview, and storage. Controller performs image processing including gain, offset, and defective pixel correction. Used in clinical settings for conventional radiography; operated by healthcare professionals. Enables immediate image quality verification without wet chemical film processing. Output transmitted via LAN for diagnostic viewing, printing, or archiving.

Clinical Evidence

Clinical Test Report provided. Device performance validated through electrical safety and electromagnetic compatibility testing per IEC 60601-1 and IEC 60601-1-2 standards.

Technological Characteristics

Solid-state X-ray imaging detector array; digital flat panel technology. System controller software runs on customer-provided PC hardware. Connectivity via LAN for image transmission. Electrical safety/EMC per IEC 60601-1 and IEC 60601-1-2.

Indications for Use

Indicated for conventional radiographic examinations in patients requiring diagnostic imaging where screen-film systems are typically used. Excludes fluoroscopic, angiographic, and mammographic applications.

Regulatory Classification

Identification

A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Special Controls

*Classification.* Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Submission Summary (Full Text)

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# Chapter III 510(k) Summary

AUG - 2 2011

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 9807.92.

The Assigned 510(k) Number is:

The Assigned 510(k) Number is:
Prepared Date: 4th, March, 2011

K110801

- 1. Device Information
Device Common Name: Solid State X-Ray Imaging Devices Device Trade/Proprietary Name: WV3000T Digital X-ray Direct Imaging Flat Panel Detector System

Classification Information:

- (1) Classification Name: Solid State X-Ray Imaging Devices
(2) Regulation Number:892.1650

- (3) Product Code: MBQ
(4) Class: II

(5) Review Panel: Radiology

#### 2. Submitter Information

#### Manufacturer:

Direct Digital Imaging Technology (Beijing) Inc. #33 Building, Yuquan Wisdom Vale, Tsinghua Science Park, #3 Min Zhuang Road Haidian District, Beijing 100097, CHINA

#### Contact Person of the Submission

Ms. Likun Fu Direct Digital Imaging Technology (Beijing) Inc. #33 Building, Yuquan Wisdom Bale, Tsinghua Science Park, # 3 Min Zhuang Road Haidian District, Beijing 100095 China Phone: [phone] Fax: [phone] Email: [e-mail]

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#### 3. Device Description

The WV300T Digital X-ray Direct Imaging Flat Panel Detector System is used to directly capture and convert conventional projection X-ray images to digital images. A image preview function can be displayed on a review monitor for viewing. The diagnostic image can be transmitted through LAN for diagnostic viewing and printing. The device provides digital image capture for conventional radiographic examinations, excluding fluoroscopic, angiographic and mammographic applications. The system differs from traditional X-ray systems in that instead of exposing a film for subsequent wet chemical processing to create a hardcopy image, a device called a detector array is used to capture the image in electronic form. The digital data are then used to produce hardcopy and softcopy images.

The WV3000T Digital X-ray Direct Imaging Flat Panel Detector System is composed of the following:

A detector array is used to capture the diagnostic image, and transfer the image to system controller in digital format.

An multi-box is used to control detector array, harmonize the working between the array controller and high-voltage generator for exposal synchronization.

A system controller is used to enter patient demographic information, initiate the exposure process, review captured images, and accept or reject captured images. The system controller is also used to send images to a hardcopy printer, workstation, or archive, and manage images temporarily stored in its database. Here, the system controller is the software device and which should install in the PC hardware system purchased by themselves of customer.

The system controller also can make some disposal for the original image, such as gain, offset and defective pixel correction.

By capturing, previewing, and storing and image, the system enables an operator to check the quality of an image at the time of exposure without having to develop a film.

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#### 4. Intended Use

The 3000T Digital X-ray Direct Imaging Flat Panel Detector System provides a digital image capture capability for conventional radiographic examinations (excluding fluoroscopic, angiographic, and mammographic applications). The device has application wherever conventional screen-film systems are currently used.

## 5. Substantially Equivalence Determination

The applicant devices Substantially Equivalent (SE) to the predicate device which is US legally market device. Therefore, the applicant devices are determined as safe and effectiveness.

### 6. Test Summary

The device is electrically operated and the electrical safety and electromagnetic compatibility following IEC 60601-1 and IEC60601-1-2 were conducted.

All the information about the device performance has provided.

The Clinical Test Report has provided.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The logo is encircled by the text "DEPARTMENT US HEALTH & HUMAN SERVICES USA" in a circular arrangement.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Mr. Likun Fu Product Manager Direct Digital Imaging Technology (Beijing), Inc. #33 Building, Yuquan Wisdon Vale, Tsinghua Science Park BEIJING 100097 CHINA

Re: K110801

Trade/Device Name: WV3000T Digital Direct Imaging Flat Panel Detector System Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB AUG 23 2013 Dated: July 4, 2011 Received: July 5, 2011

Dear Mr. Fu:

This letter corrects our substantially equivalent letter of August 2, 2011.

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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter roquions as bet for are as a gour 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 CFF Parts 801 and 11 you desire specific at 100 tor Joan 10 in Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket s 150. Thouse now as a 100.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

under the MDK regulation (2) "CFRT at 005), product government of 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 Tou may 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,

Janine M. Morris

Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## Indication For Use

510(k) Number (if known): __ Pending

Device Name: __ WV3000T Digital Direct Imaging Flat Panel Detector System

Indications for Use:

The WV3000T Digital X-ray Direct Imaging Flat Panel Detector System provides a digital image capture capability for conventional radiographic examinations (excluding fluoroscopic, angiographic, and mammographic applications). The device has application wherever conventional screen-film systems are currently used.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ V (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _____ (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation {ODE}

Mary S. Lattel

Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

.510K. K110801

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