Digital Radiography CXDI-Pro, Digital Radiography D1

K220098 · Canon, Inc. · MQB · Feb 4, 2022 · Radiology

Device Facts

• Record ID: K220098
• Device Name: Digital Radiography CXDI-Pro, Digital Radiography D1
• Applicant: Canon, Inc.
• Product Code: MQB · Radiology
• Decision Date: Feb 4, 2022
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1680
• Device Class: Class 2

Intended Use

The DIGITAL RADIOGRAPHY CXDI-Pro / DIGITAL RADIOGRAPHY D1 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 imager (flat panel detector) for general radiography; captures X-ray photons via scintillator (CsI(Tl)) to generate electrical signals; converts signals to digital images for display on operator console. System includes wireless detectors (CXDI-703C, CXDI-403C), detector stand, battery charger, and control software. Used in clinical settings by radiographers/technicians. Provides digital images to assist clinicians in diagnostic decision-making; replaces traditional film/screen systems. Benefits include faster image acquisition and digital workflow integration.

Clinical Evidence

Bench testing only. Verification and validation activities confirmed that modifications (new detector, accessories, software update) meet performance standards and voluntary safety standards, including IEC 60601-1, 60601-1-2, 60601-2-54, 60601-1-6, and IEC 60529. No clinical data required.

Technological Characteristics

Solid-state X-ray imager; Magnesium alloy case; CsI(Tl) scintillator; 140μm pixel pitch; 35% MTF@2lp/mm spatial resolution; IP55 rating. Connectivity: IEEE 802.11n/ac/a/g/b (2.4GHz/5GHz) and Bluetooth Low Energy. Software: CXDI Control Software V3.10.0.8. Standards: IEC 60601-1, 60601-1-2, 60601-2-54, 60601-1-6, IEC 60529.

Indications for Use

Indicated for digital image capture of human anatomy for general purpose diagnostic radiographic procedures. Not for mammography. Applicable to patients requiring conventional radiographic examinations.

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-Pro / DIGITAL RADIOGRAPHY D1 (K212553)

Submission Summary (Full Text)

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February 4, 2022

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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

Re: K220098

Trade/Device Name: Digital Radiography CXDI-Pro, Digital Radiography D1 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB Dated: January 11, 2022 Received: January 12, 2022

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 mediation-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,

Laurel Burk Assistant Director Diagnostic X-ray Systems Team 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) K220098

Device Name DIGITAL RADIOGRAPHY CXDI-Pro DIGITAL RADIOGRAPHY D1

#### Indications for Use (Describe)

The DIGITAL RADIOGRAPHY CXDI-Pro / D1 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) |
|-------------------------------------------------|
|-------------------------------------------------|

> Prescription Use (Part 21 CFR 801 Subpart D)

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

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K220098

| Applicant/Sponsor: | Canon Inc.<br>9-1 Imaikami-cho<br>Nakahara-ku, Kanagawa 211-8501 Japan |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mr. Akira Hirai<br>General Manager<br>TEL: [phone];<br>FAX: [phone]<br>[e-mail] |
| Date Prepared: | January 28, 2022 |
| Submission Type: | Special 510(k) Submission |
| Proposed Device: | Manufacturer: Canon Inc.<br>Trade Name: DIGITAL RADIOGRAPHY CXDI-Pro<br>DIGITAL RADIOGRAPHY D1<br>Common Name: Solid State X-Ray Imager (Flat Panel/Digital Imager)<br>Classification Name: Stationary X-ray System<br>Classification: 892.1680, Stationary X-ray System<br>Product Code: MQB |
| Predicate Device: | 510k Number: K212553<br>Manufacturer: Canon Inc.<br>Trade Name: DIGITAL RADIOGRAPHY CXDI-Pro<br>DIGITAL RADIOGRAPHY D1<br>Common Name: Solid State X-Ray Imager (Flat Panel/Digital Imager)<br>Classification Name: Stationary X-ray System<br>Classification: 892.1680, Stationary X-ray System<br>Product Code: MQB |
| Device Description: | The DIGITAL RADIOGRAPHY CXDI-Pro, also called the DIGITAL<br>RADIOGRAPHY D1, (hereinafter referred to as CXDI-Pro) is a solid-state x-ray<br>imager. The CXDI-Pro is a series of detectors, and in the predicate device consists of<br>the CXDI-703C Wireless detector unit, also called the AR-D3543W detector. The<br>detector intercepts x-ray photons, and the scintillator emits visible spectrum photons<br>that illuminate an array of photodetectors that create electrical signals. After the<br>electrical signals are generated, the signals are converted to digital values, and the<br>images will be displayed on monitors. The digital image can be communicated to the<br>operator console via a wired or wireless connection.<br>The subject of this Special 510(k) submission is a change to the CXDI-Pro add a<br>detector, the CXDI-403C Wireless (also called AR-D4343W) to the CXDI-Pro series<br>of detectors. In addition, a Detector Stand (DS-01) and a new Battery Charger (BC-<br>01) have been added as optional components to be used with the proposed CXDI-Pro<br>detectors (CXDI-703C Wireless and CXDI-403C Wireless), the sleep to ready cycle<br>time for the proposed CXDI-Pro detectors has been decreased, and the CXDI Contro<br>Software has been updated from V3.10.0.3 to V3.10.0.8 to add the Intelligent NR<br>function (cleared under K212269) and apply some bug fixes. Together, these<br>changes make up the CXDI-Pro. |

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## K220098

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

> The DIGITAL RADIOGRAPHY CXDI-Pro / DIGITAL RADIOGRAPHY D1 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.

Summary of Comparison with the predicate device shows the characteristics of the proposed Technological modifications (addition of a new detector and additional optional accessories) to the Characteristics: CXDI-Pro to be substantially equivalent to the predicate device.

| | Proposed Device | Predicate Device | |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Trade Name | DIGITAL RADIOGRAPHY CXDI-Pro /<br>DIGITAL RADIOGRAPHY D1 | | |
| 510(k) Submitter<br>[Number] | Canon Inc.<br>[K220098] | Canon Inc.<br>[K212553] | IDENTICAL |
| Indication for Use | The DIGITAL RADIOGRAPHY CXDI-Pro /<br>DIGITAL RADIOGRAPHY D1 provides<br>digital image capture for conventional<br>film/screen radiographic examinations. This<br>device is intended to capture, for display,<br>radiographic images of human anatomy, and<br>to replace radiographic film/screen systems in<br>all general purpose diagnostic procedures.<br>This device is not intended for mammography<br>applications. | The DIGITAL RADIOGRAPHY CXDI-Pro /<br>DIGITAL RADIOGRAPHY D1 provides<br>digital image capture for conventional<br>film/screen radiographic examinations. This<br>device is intended to capture, for display,<br>radiographic images of human anatomy, and<br>to replace radiographic film/screen systems in<br>all general purpose diagnostic procedures.<br>This device is not intended for mammography<br>applications. | IDENTICAL |
| Application | General Radiography | General Radiography | IDENTICAL |
| Case Material | Magnesium alloy | Magnesium alloy | IDENTICAL |
| Scintillator | CsI(Tl)<br>[Cesium Iodide doped with Thallium] | CsI(Tl)<br>[Cesium Iodide doped with Thallium] | IDENTICAL |
| Pixel Pitch | 140μm | 140μm | IDENTICAL |
| Spatial<br>Resolution | 35% [MTF@2lp/mm] | 35% [MTF@2lp/mm] | IDENTICAL |
| IP Level | IP55 | IP55 | IDENTICAL |
| Detector(s) | CXDI-703C Wireless (AR-D3543W)<br>CXDI-403C Wireless (AR-D4343W) | CXDI-703C Wireless (AR-D3543W) | MODIFIED |
| Components | Detector (Sensor)<br>Battery Charger (BC-1A)<br>Battery Pack (LB-4A)<br>X-ray Interface Box (XB-1A)<br>Power Box (PB-01)<br>Wiring Cable (WC-01)<br>PC Connection Cable (CP-01)<br>Ready Indicator (RI-3A)<br>Detector Stand (DS-01)<br>Battery Charger (BC-01) | Detector (Sensor)<br>Battery Charger (BC-1A)<br>Battery Pack (LB-4A)<br>X-ray Interface Box (XB-1A)<br>Power Box (PB-01)<br>Wiring Cable (WC-01)<br>PC Connection Cable (CP-01)<br>Ready Indicator (RI-3A)<br>Battery Charger (BC-01) | MODIFIED |
| Software | CXDI Control Software V3.10.0.8 | CXDI Control Software V3.10.0.3 | MODIFIED |
| Photographing<br>Mode | Standard Synchronization Mode, Non<br>Generator Connection Mode | Standard Synchronization Mode, Non<br>Generator Connection Mode | IDENTICAL |
| Wireless<br>Communication | IEEE 802.11n/ac/a/g/b 2.4GHz/5GHz<br>Bluetooth Low Energy | IEEE 802.11n/ac/a/g/b 2.4GHz/5GHz<br>Bluetooth Low Energy | IDENTICAL |
| Cycle Time: Sleep<br>to Ready Time | Cycle Time is less than 5 sec when the<br>storage time is set to 100ms | Cycle Time is 7 sec when the storage time is<br>set to 100ms | MODIFIED |

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Image /page/5/Picture/0 description: The image shows the word "Canon" in a stylized red font at the top. Below the word "Canon" is the text "510(k) SUMMARY" in a bold, black font. The text is centered below the Canon logo. The background of the image is white.

# K220098

| | The User's and Installation Manuals provide detailed instructions and information<br>for safe and effective use of the device, and users are expected to adhere to the<br>instructions and other information. The User's Manual explains how to use the<br>detector and other equipment. Connected medical equipment, such as x-ray<br>generators, must comply with IEC 60601-1. |
|--------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance: | The fundamental scientific technology of the CXDI-Pro has not been modified. The<br>changes are the addition of a new detector, CXDI-403C Wireless (AR-D4343W); the<br>addition of optional accessories, a Detector Stand (DS-01) and a different Battery<br>Charger (BC-01); a decrease in the sleep to ready cycle time; the update to the CXDI<br>Control Software from 3.10.0.3 to 3.10.0.8; and the update to the detector firmware<br>from 01.00.00.03 to 01.00.02.00.<br><br>Evaluation of the addition of the new detector and optional accessories confirmed<br>that the changes did not impact CXDI-Pro conformance with the U.S. Performance<br>Standard for radiographic equipment and with relevant voluntary safety standards for<br>Electrical safety and Electromagnetic Compatibility testing, specifically IEC<br>standards 60601-1, 60601-1-2, 60601-2-54, 60601-1-6, and IEC 60529.<br><br>These verification/validation activities successfully demonstrated that the device<br>continues to meet the standards for the areas impacted by the modifications to the<br>predicate device and raises no new questions regarding either safety or effectiveness<br>when compared to the predicate device. Therefore, the verification/validation<br>activities conducted support a determination of substantial equivalence for the<br>CXDI-Pro. |
| Conclusion: | Canon Inc. considers the CXDI-Pro to be substantially equivalent to the predicate<br>device listed above. This conclusion is based on the similarities in primary intended<br>use, principles of operation, functional design, and established medical use. |