BSD4343R Digital Flat Panel X-ray Detector

K171485 · Bontech, Inc. · MQB · Jun 21, 2017 · Radiology

Device Facts

• Record ID: K171485
• Device Name: BSD4343R Digital Flat Panel X-ray Detector
• Applicant: Bontech, Inc.
• Product Code: MQB · Radiology
• Decision Date: Jun 21, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1680
• Device Class: Class 2

Intended Use

The BSD4343R Digital Flat Panel X-ray Detector (Model: BT-DA24-IA) is indicated for digital imaging solution designed for general radiographic system for human anatomy. It is intended to replace film or screen based radiographic system in all general-purpose diagnostic procedures. It is not to be used for mammography.

Device Story

The BSD4343R is a digital flat panel X-ray detector (FPD) designed to replace traditional film or screen-based radiographic systems. It captures X-ray radiation transmitted through human anatomy and converts it into digital image data. The device is intended for use in general-purpose diagnostic radiographic procedures by trained healthcare professionals. It functions as a component within a larger radiographic system, providing digital output for clinical review and diagnostic decision-making. By enabling digital image acquisition, the device facilitates faster image processing, storage, and transmission compared to analog systems, potentially improving clinical workflow and diagnostic efficiency.

Clinical Evidence

Bench testing only.

Technological Characteristics

Digital flat panel X-ray detector; intended for general radiographic systems; excludes mammography applications. Operates as a component of a stationary X-ray system. Connectivity via standard digital interface for image data transfer.

Indications for Use

Indicated for digital radiographic imaging of human anatomy in general-purpose diagnostic procedures. Contraindicated for mammography.

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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Public Health Service

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

June 21, 2017

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Bontech Inc. % Dave Kim Medical Device Regulatory Affairs Mtech Group 8310 Buffalo Speedway Houston, Texas 77025

Re: K171485

Trade/Device Name: BSD4343R Digital Flat Panel X-ray Detector Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MOB Dated: May 17, 2017 Received: May 22, 2017

Dear Dave Kim:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

Michael D. O'Hara

For

Robert A. Ochs. Ph.D Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K171485

Device Name BSD4343R Digital Flat Panel X-ray Detector

## Indications for Use (Describe)

The BSD4343R Digital Flat Panel X-ray Detector (Model: BT-DA24-IA) is indicated for digital imaging solution designed for general radiographic system for human anatomy. It is intended to replace film or screen based radiographic system in all general-purpose diagnostic procedures. It is not to be used for mammography.

Type of Use (Select one or both, as applicable)

| <span style="font-family: Arial;"> <svg height="12" width="12"> <rect fill="none" height="12" stroke="black" width="12" x="0" y="0"></rect> <path d="M2,2 L10,10 M2,10 L10,2" stroke="black"></path> </svg> Prescription Use (Part 21 CFR 801 Subpart D)</span> |
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| <span style="font-family: Arial;"> <svg height="12" width="12"> <rect fill="none" height="12" stroke="black" width="12" x="0" y="0"></rect> </svg> Over-The-Counter Use (21 CFR 801 Subpart C)</span> |

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