DIGITAL RADIOGRAPHY CXDI-702C Wireless, DIGITAL RADIOGRAPHY CXDI-402C Wireless

K192632 · Canon, Inc. · MQB · Nov 7, 2019 · Radiology

Device Facts

• Record ID: K192632
• Device Name: DIGITAL RADIOGRAPHY CXDI-702C Wireless, DIGITAL RADIOGRAPHY CXDI-402C Wireless
• Applicant: Canon, Inc.
• Product Code: MQB · Radiology
• Decision Date: Nov 7, 2019
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1680
• Device Class: Class 2

Intended Use

The DIGITAL RADIOGRAPHY CXDI-702C Wireless and CXDI-402C Wireless provides digital image capture for conventional film/screen radiographic examinations. This device is intended to capture, for display, radiographic images of human anatomy, and to replace radiographic film/screen systems in all general purpose diagnostic procedures. This device is not intended for mammography applications.

Device Story

Solid-state X-ray imagers (flat panel detectors) capture X-ray photons using a CsI(Tl) scintillator; converts visible light to electrical signals; digitizes signals for display on monitors. Used in clinical settings for general radiography; operated by trained healthcare professionals. Features include wireless/wired communication to control console; optional X-ray I/F unit for generator synchronization; Advanced Edge Enhancement feature automatically adjusts six image processing parameters (edge enhancement, frequency, contrast boost, dynamic range, noise reduction) to improve structure visualization. Magnesium alloy casing; IP54 rated. Replaces film/screen systems; aids clinical decision-making through high-resolution digital imaging.

Clinical Evidence

Bench testing only. Included verification/validation of functional specifications, software testing, and non-clinical image quality comparisons (including Advanced Edge Enhancement feature) against predicate devices. Usability interviews conducted with clinicians regarding Advanced Edge Enhancement. Compliance with IEC 60601-1, 60601-1-2, 60601-1-6, 60601-2-54, and ISO 10993-1/5/10 biocompatibility standards confirmed.

Technological Characteristics

Solid-state flat panel detector; CsI(Tl) scintillator; 125µm pixel pitch. Magnesium alloy casing. Connectivity: Wired/Wireless to control PC/Multi Box/X-ray I/F unit. IP54 ingress protection. Software: CXDI Control Software V 2.19. Standards: IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), ISO 10993 (biocompatibility).

Indications for Use

Indicated for digital image capture for conventional film/screen radiographic examinations of human anatomy in general purpose diagnostic procedures. Not 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.

Predicate Devices

• DIGITAL RADIOGRAPHY CXDI-710C Wireless (K170332)

Reference Devices

• DIGITAL RADIOGRAPHY CXDI-410C Wireless (K171270)
• CXDI-701C Wireless (K131106)

Submission Summary (Full Text)

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November 7, 2019

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font size below.

Canon, Inc. % Mr. Gregory Woodard Biomedical Engineer Ken Block Consulting 800 East Campbell Road, Suite 202 RICHARDSON TX 75081

### Re: K192632

Trade/Device Name: DIGITAL RADIOGRAPHY CXDI-702C Wireless DIGITAL RADIOGRAPHY CXDI-402C Wireless Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB Dated: November 6, 2019 Received: November 7, 2019

Dear Mr. Woodard:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 Part 807); labeling (21 CFR Part

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K192632

Device Name DIGITAL RADIOGRAPHY CXDI-702C Wireless DIGITAL RADIOGRAPHY CXDI-402C Wireless

#### Indications for Use (Describe)

The DIGITAL RADIOGRAPHY CXDI-702C Wireless and CXDI-402C Wireless provides digital image capture for conventional film/screen radiographic examinations. This device is intended to capture, for display, radiographic images of human anatomy, and to replace radiographic film/screen systems in all general purpose diagnostic procedures. This device is not intended for mammography applications.

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

| <span> <span style="font-size: 20px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
|--------------------------------------------------------------------------------------------------------|
| <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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Image /page/3/Picture/0 description: The image shows the word "Canon" in red font. The font is bold and slightly italicized. The word is centered and takes up most of the image.

# 510(k) SUMMARY

| Submitter: | Canon, Inc.<br>30-2 Shimomaruko, 3-chrome<br>Ohta-ku, Tokyo 146-8501 Japan |
|----------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mr. Tatsuya Yamazaki<br>General Manager<br>TEL: [phone];<br>FAX: [phone]<br>[e-mail] |
| Date Prepared: | September 20, 2019 |
| Submission Type: | Special 510(k) Submission |
| Proposed Devices: | 510(k) Number: K192632<br>Manufacturer: Canon, Inc.<br>Trade Name: DIGITAL RADIOGRAPHY CXDI-702C Wireless<br>DIGITAL RADIOGRAPHY CXDI-402C Wireless<br>Common Name: Solid State X-Ray Imager (Flat Panel/Digital Imager)<br>Classification Name: Stationary X-ray system<br>Product Code: MQB<br>Regulatory Standard: 892.1680 (Stationary X-ray System) |
| Predicate Device: | Manufacturer: Canon, Inc.<br>510(k) Number: K170332<br>Trade Name: DIGITAL RADIOGRAPHY CXDI-710C Wireless<br>Common Name: Solid State X-Ray Imager (Flat Panel/Digital Imager)<br>Classification Name: Stationary X-ray system<br>Product Code: MQB<br>Regulatory Standard: 892.1680 (Stationary X-ray System) |
| Reference Device: | Manufacturer: Canon, Inc.<br>510(k) Number: K171270<br>Trade Name: DIGITAL RADIOGRAPHY CXDI-410C Wireless<br>Common Name: Solid State X-Ray Imager (Flat Panel/Digital Imager)<br>Classification Name: Stationary X-ray system<br>Product Code: MQB<br>Regulatory Standard: 892.1680 (Stationary X-ray System) |
| Device Description: | The CXDI-702C Wireless and CXDI-402C Wireless are solid-state x-ray imagers with approximate imaging areas of 350 x 426 mm and 415 x 426 mm, respectively. The detector intercepts x-ray photons, and the scintillator emits visible spectrum photons that illuminate an array of photodetectors that create electrical signals. After the electrical signals are generated, the signals are converted to digital values and the images will be displayed on monitors. The digital value can be communicated to the operator console via wired or wireless connection.<br>The subject of this Special 510(k) submission is a change to the Digital Radiography CXDI-710C Wireless and CXDI-410C Wireless to add the X-ray I/F unit option, update to the CXDI control software, change the IP Level, make changes to the case, and remove Standalone mode. The X-Ray I/F unit synchronizes the timing of the X-ray irradiation with the detector's capture and has been included in other Canon devices (CXDI-701C Wireless (K131106)). The X-Ray I/F Unit is an optional unit that allows the proposed device work together with several older units that use the X-ray I/F Unit instead of the multibox. The IP Level was changed from IPX7 to IP54. The Standalone mode was removed from the proposed devices. The imaging process to |
| sharpen images, Edge Enhancement, was included in the Digital Radiography CXDI- | |
| 710C Wireless and CXDI-410C Wireless, but adjustments of multiple imaging | |
| parameters were required to enhance structured edges. The optional feature, Advanced | |
| Edge Enhancement, for CXDI-702C Wireless and CXDI-402C Wireless automatically | |
| adjusts the six image processing parameters (Enhancement - Edge Enhancement, | |
| Enhancement - Edge Frequency, Enhancement - Contrast Boost, Dynamic Range | |
| Adjustment - Dark Region, Dynamic Range Enhancement - Bright Region, and Noise | |
| Reduction - Effect) by one button to enhance structures. The CXDI control software | |
| has been updated to a new version for functional improvements. The material of the | |
| casing of the detector has changed from fiberglass to magnesium alloy. Together, these | |
| changes to the Digital Radiography CXDI-710C Wireless and CXDI 410C Wireless | |
| make up the Digital Radiography CXDI-702C Wireless and CXDI-402C Wireless. | |
| The Digital Radiography CXDI-710C Wireless and CXDI-410C Wireless clearances | |
| are not impacted by this submission. | |
| | |

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Indication for Use: The Indication for Use statement is identical to the predicate device with the exception of the device name. The intended use of the modified device, as described in the labeling, has not changed as a result of the modification(s).

> The DIGITAL RADIOGRAPHY CXDI-702C Wireless and CXDI-402C Wireless provides digital image capture for conventional film/screen radiographic examinations. This device is intended to capture, for display, radiographic images of human anatomy, and to replace radiographic film/screen systems in all general purpose diagnostic procedures. This device is not intended for mammography applications.

Comparisons with the predicate devices show the characteristics of the proposed Summary of Technological modifications (addition of the X-Ray I/F unit option, the update to the CXDI control Characteristics: software, change in case material, and the removal of the Standalone mode) to the DIGITAL RADIOGRAPHY CXDI-710C Wireless and CXDI-410C Wireless to be substantially equivalent to the predicate device.

| Trade Name | Proposed Device | Proposed Device | Predicate Device | Reference Device | |
|---------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Trade Name | DIGITAL<br>RADIOGRAPHY<br>CXDI-702C Wireless | DIGITAL<br>RADIOGRAPHY<br>CXDI-402C Wireless | DIGITAL<br>RADIOGRAPHY<br>CXDI-710C Wireless | DIGITAL<br>RADIOGRAPHY<br>CXDI-410C Wireless | |
| 510(k)<br>Submitter<br>[Number] | Canon, Inc.<br>[K192632] | | Canon, Inc.<br>[K170332] | Canon, Inc.<br>[K171270] | IDENTICAL |
| Indication for<br>Use | The DIGITAL<br>RADIOGRAPHY<br>CXDI-702C Wireless<br>provides digital image<br>capture for<br>conventional<br>film/screen<br>radiographic<br>examinations. This<br>device is intended to<br>capture, for display,<br>radiographic images of<br>human anatomy, and to<br>replace radiographic<br>film/screen systems in<br>all general purpose<br>diagnostic procedures.<br>This device is not<br>intended for | The DIGITAL<br>RADIOGRAPHY<br>CXDI-402C Wireless<br>provides digital image<br>capture for<br>conventional<br>film/screen<br>radiographic<br>examinations. This<br>device is intended to<br>capture, for display,<br>radiographic images of<br>human anatomy, and to<br>replace radiographic<br>film/screen systems in<br>all general purpose<br>diagnostic procedures.<br>This device is not<br>intended for | The DIGITAL<br>RADIOGRAPHY<br>CXDI-710C Wireless<br>provides digital image<br>capture for<br>conventional<br>film/screen<br>radiographic<br>examinations. This<br>device is intended to<br>capture, for display,<br>radiographic images of<br>human anatomy, and to<br>replace radiographic<br>film/screen systems in<br>all general purpose<br>diagnostic procedures.<br>This device is not<br>intended for | The DIGITAL<br>RADIOGRAPHY<br>CXDI-410C Wireless<br>provides digital image<br>capture for<br>conventional<br>film/screen<br>radiographic<br>examinations. This<br>device is intended to<br>capture, for display,<br>radiographic images of<br>human anatomy, and to<br>replace radiographic<br>film/screen systems in<br>all general purpose<br>diagnostic procedures.<br>This device is not<br>intended for | IDENTICAL |

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Image /page/5/Picture/0 description: The image contains the word "Canon" in a bold, red font. The letters are large and closely spaced together, creating a strong visual impact. The font appears to be a sans-serif typeface, giving it a modern and clean look. The red color contrasts sharply with the white background, making the word stand out.

| | mammography<br>applications. | mammography<br>applications. | mammography<br>applications. | mammography<br>applications. | |
|---------------------------|----------------------------------------------------------------------------------|-------------------------------|-----------------------------------------------------------------------------------|-------------------------------|-----------|
| Application | General Radiography | | General Radiography | | IDENTICAL |
| Case Material | Magnesium alloy | | Fiberglass | | MODIFIED |
| Scintillator | CsI(Tl)<br>[Cesium Iodide doped with Thallium] | | CsI(Tl)<br>[Cesium Iodide doped with Thallium] | | IDENTICAL |
| Pixel Pitch | 125µm | | 125µm | | IDENTICAL |
| Pixels | 2,800 x 3,408<br>(≈ 9.5 mil) | 3,408 x 3,320<br>(≈ 11.3 mil) | 2,800 x 3,408<br>(≈ 9.5 mil) | 3,408 x 3,320<br>(≈ 11.3 mil) | IDENTICAL |
| External<br>Dimensions | 384 x 460 x 15.7 mm | 460 x 460 x 15.7 mm | 384 x 460 x 15.7 mm | 460 x 460 x 15.7 mm | IDENTICAL |
| Weight | ≈ 3.1 kg | ≈ 3.7 kg | ≈ 2.3 kg | ≈ 2.8 kg | MODIFIED |
| Attenuation<br>Equivalent | Max. 0.40 mmAl | Max. 0.37 mmAl | Max. 0.21 mmAl | | MODIFIED |
| Spatial<br>Resolution | 35% [MTF@2lp/mm] | | 35% [MTF@2lp/mm] | | IDENTICAL |
| Control SW | CXDI Control Software V 2.19 | | CXDI Control Software V 2.16 | | MODIFIED |
| Wireless<br>Functions | Communication between Detector and:<br>Multi Box<br>Control PC<br>X-ray I/F Unit | | Communication between Detector and:<br>Multi Box<br>Control PC | | MODIFIED |
| IP Level | IP54 | | IPX7 | | MODIFIED |
| Photographing<br>mode | Standard Synchronization Mode<br>Non Generator Connection Mode | | Standard Synchronization Mode<br>Non Generator Connection Mode<br>Standalone Mode | | MODIFIED |

The User's and Installation Manuals provide detailed instructions and information for safe and effective use of the device and users are expected to adhere to the instructions and other information. The User's Manual explains how to use the detector and other equipment. Connected medical equipment, such as X-ray generators, must comply with IEC 60601-1. Before using the product, be sure to read the manual thoroughly in order to utilize it more effectively.

Summary of Non-Clinical / Test Data:

The fundamental scientific technology of the DIGITAL RADIOGRAPHY CXDI-702C Wireless and CXDI-402C Wireless has not been modified. The risks and hazardous impacts of the device modification were analyzed by FMEA methodology. The specific risk control and protective measures to mitigate the risks from the modification were reviewed and implemented as part of product design. The overall assessment concluded that all identified risks and hazardous conditions were successfully mitigated and accepted.

Tests were performed on the models which demonstrated that the devices are safe and effective, perform comparably to the predicate devices, and are substantially equivalent to the predicate devices. Tests included verification/validation testing to internal functional specifications (including software) and non-clinical image comparisons involving flat panel display images taken by the new device and the predicate devices, including the Advanced edge enhancement feature. Interviews were conducted with experienced clinicians on the usability of the advanced edge enhancement.

Documentation was provided demonstrating compliance of the CXDI-702C Wireless and CXDI-402C Wireless to all FDA requirements stated in Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices for a moderate LOC, including results of verification/validation plus traceability of verification/validation tests to software requirements and software risk hazards.

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Image /page/6/Picture/0 description: The image shows the word "Canon" in a bold, red font. The letters are slightly stylized, with a slight curve to the top of the "C" and a distinctive shape to the "n". The word is presented against a white background, making the red color stand out.

Other FDA guidance documents used in development include Radio Frequency Wireless Technology in Medical Devices and Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.

Documentation was provided demonstrating that the changes to CXDI-710C and CXDI-410C do not impact the device's compliance with FDA requirements stated in Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices.

Testing confirmed that the CXDI-702C Wireless and CXDI-402C Wireless comply with the U.S. Performance Standard for radiographic equipment and with relevant voluntary safety standards for Electrical safety and Electromagnetic Compatibility testing, specifically IEC standards 60601-1, 60601-1-2, 60601-1-6, and 60601-2-54.

Biocompatibility evaluation confirmed that the changes to CXDI-710C and CXDI-410C do not impact the devices' safety and that the CXDI-702C Wireless and CXDI-402C Wireless comply with ISO 10993-1, 10993-5, and 10993-10.

Together, these verification/validation activities successfully demonstrated that the device continues to meet the standards for the areas impacted by the device modifications to the predicate device and raises no new questions regarding either safety or effectiveness when compared to the predicate device. Therefore, the verification/validation testing conducted supports a determination of substantial equivalence for the CXDI-702C Wireless and CXDI-402C Wireless devices.

Conclusion: Canon, Inc. considers the DIGITAL RADIOGRAPHY CXDL-702C Wireless and CXDI-402C Wireless to be substantially equivalent to the predicate devices listed above. This conclusion is based on the similarities in primary intended use, principles of operation, functional design, and established medical use.