Digital Radiography CXDI-Elite, Digital Radiography E1

{0}------------------------------------------------ June 14, 2022 Image /page/0/Picture/1 description: The image contains two logos. The logo on the left is the Department of Health & Human Services logo. The logo on the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. Canon Inc. % Mr. Gregory Woodard Biomedical Engineer Ken Block Consulting, LLC 800 East Campbell Road, Suite 202 RICHARDSON TX 75081 ## Re: K221620 Trade/Device Name: Digital Radiography CXDI-Elite, Digital Radiography E1 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB Dated: June 2, 2022 Received: June 3, 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 {1}------------------------------------------------ 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Laurel Burk, Ph.D. Assistant Director Diagnostic X-ray Systems Team DHT 8B: Division of Radiological Imaging and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K221620 Device Name DIGITAL RADIOGRAPHY CXDI-Elite DIGITAL RADIOGRAPHY El #### Indications for Use (Describe) The DIGITAL RADIOGRAPHY CXDI-Elite / El 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) | |--------------------------------------------------------------| | ☑ Research Use Only (21 CFR 201.3 Subject to 501(e)) | | ☐ Over-The-Counter Use Only (21 CFR 201.3 Subject to 501(e)) | > Prescription Use (Part 21 CFR 801 Subpart D) __ Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # K221620 Image /page/3/Picture/1 description: The image shows the Canon logo in red, with the text "510(k) SUMMARY" written in black below it. The Canon logo is a stylized version of the company's name. The text "510(k) SUMMARY" is written in a simple, sans-serif font. The image is likely from a document related to the regulatory approval process for a medical device manufactured by Canon. | Applicant/<br>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: 81-3-3758-2111<br>FAX: 044-739-6695<br>hirai.akira@mail.canon | | | Date Prepared: | June 10, 2022 | | | Proposed Device | Manufacturer:<br>Trade Name: | Canon Inc.<br>DIGITAL RADIOGRAPHY CXDI-Elite<br>DIGITAL RADIOGRAPHY E1 | | | Common Name:<br>Classification Name:<br>Product Code:<br>Regulation: | Solid State X-Ray Imager (Flat Panel/Digital Imager)<br>Stationary X-ray System<br>MQB<br>892.1680, Stationary X-ray System | | Predicate Device: | Clearance:<br>Manufacturer:<br>Trade Name: | K213780<br>Canon Inc.<br>DIGITAL RADIOGRAPHY CXDI-Elite<br>DIGITAL RADIOGRAPHY E1 | | | Common Name:<br>Classification Name:<br>Product Code:<br>Regulation: | Solid State X-ray Imager (Flat Panel/Digital Imager)<br>Stationary X-ray System<br>MQB<br>892.1680, Stationary X-ray System | | Device<br>Description: | The DIGITAL RADIOGRAPHY CXDI-Elite, also called the DIGITAL<br>RADIOGRAPHY E1, (hereinafter referred to as CXDI-Elite) is a solid-state x-ray<br>imager. The CXDI-Elite is a series of detectors, and in the predicate device consists of<br>the CXDI-720C Wireless detector unit, also called the AR-E3543W 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 value can be communicated to the<br>operator console via a wired or wireless connection. | | | | The subject of this Special 510(k) submission is a change to the CXDI-Elite to add new<br>detectors, the CXDI-420C Wireless (also called AR-E4343W) and the CXDI-420C<br>Fixed (also called AR-E4343S), to the CXDI-Elite series of detectors. In addition, a<br>Detector Stand (DS-01) has also been added as a component to be used with both the<br>CXDI-720C Wireless and CXDI-420C Wireless. Compatibility with the Power Box<br>(PB-01), a CXDI-Pro component that was cleared under K220098 has also been added.<br>The CXDI Control Software has been updated from V3.10.0.4 to V3.10.2.2 to fix some<br>bugs, update the GPU driver, and add several minor functional changes. Together, these<br>changes make up the CXDI-Elite. | | | Indications for<br>Use: | The DIGITAL RADIOGRAPHY CXDI-Elite / E1 provides digital image capture for<br>conventional film/screen radiographic examinations. This device is intended to capture,<br>for display, radiographic images of human anatomy, and to replace radiographic<br>film/screen systems in all general purpose diagnostic procedures. This device is not<br>intended for mammography applications. | | | Summary of<br>Technological<br>Characteristics: | Comparison with the predicate device shows the technological characteristics of the<br>CXDI-Elite is substantially equivalent to the predicate device. The flat panel detector<br>units are functionally similar, but one of the proposed detectors, CXDI-420C Fixed,<br>removes Standalone Mode as a photographing mode. | | {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the word "Canon" in a stylized, red font. Below the word "Canon" is the text "510(k) SUMMARY" in a bold, black font. The text is centered below the Canon logo. The image appears to be a document header or title page. The major differences between the CXDI-Elite and the predicate are differences in standard and optional components, newer version of CXDI control software, difference in case material, and a photographing mode not available in the predicate device. The proposed indications for use statement is identical to the predicate device. | | Proposed Device | Predicate Device | | |--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------| | Trade Name | DIGITAL RADIOGRAPHY CXDI-Elite / E1 | DIGITAL RADIOGRAPHY CXDI-Elite / E1 | | | 510(k) Submitter<br>[Number] | Canon Inc.<br>[TBD] | Canon Inc.<br>[K213780] | IDENTICAL | | Indication for Use | The DIGITAL RADIOGRAPHY CXDI-Elite / E1<br>provides digital image capture for conventional<br>film/screen radiographic examinations. This device is<br>intended to capture, for display, radiographic images of<br>human anatomy, and to replace radiographic<br>film/screen systems in all general purpose diagnostic<br>procedures. This device is not intended for<br>mammography applications. | The DIGITAL RADIOGRAPHY CXDI-<br>Elite / E1 provides digital image capture<br>for conventional film/screen radiographic<br>examinations. This device is intended to<br>capture, for display, radiographic images<br>of human anatomy, and to replace<br>radiographic film/screen systems in all<br>general purpose diagnostic procedures.<br>This device is not intended for<br>mammography applications. | IDENTICAL | | Application | General Radiography | General Radiography | IDENTICAL | | Components | CXDI-720C Wireless and CXDI-420C Wireless:<br>Detector (Sensor)<br>Battery Pack (LB-4A)<br>Battery Charger (BC-01/BC-1A)<br>Multi Box (MB-02)<br>Status Indicator (SI-01/SI-4A)<br>Wiring Cable (WC-01)<br>PC Connection Cable (CP-01)<br>Ready Indicator (RI-3A)<br>X-ray Interface Box (XB-1A)<br>Detector Stand (DS-01)<br>CXDI-420C Fixed:<br>Detector (Sensor)<br>Multi Box (MB-02)<br>Status Indicator (SI-01/SI-4A)<br>Ready Indicator (RI-3A)<br>X-ray Interface Box (XB-1A) | Detector (Sensor)<br>Battery Pack (LB-4A)<br>Battery Charger (BC-01/BC-1A)<br>Multi Box (MB-02)<br>Status Indicator (SI-01/SI-4A)<br>Wiring Cable (WC-01)<br>PC Connection Cable (CP-01)<br>Ready Indicator (RI-3A)<br>X-ray Interface Box (XB-1A) | MODIFIED | | Other Compatible<br>Components | Power Box (PB-01) | N/A | MODIFIED | | Software | CXDI Control Software V3.10 | CXDI Control Software V3.10 | MODIFIED | | Detector | CXDI-720C Wireless (AR-E3543W)<br>CXDI-420C Wireless (AR-E4343W)<br>CXDI-420C Fixed (AR-E4343S) | CXDI-720C Wireless<br>(AR-E3543W) | MODIFIED | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image contains the word "Canon" in a large, bold, red font. Below the word "Canon" is the text "510(k) SUMMARY" in a smaller, bold, black font. The text is centered below the word "Canon". | Pixel Pitch | 125μm | 125µm | IDENTICAL | |---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|-----------| | Scintillator | CsI(Tl)<br>[Cesium Iodide doped with Thallium] | CsI(Tl)<br>[Cesium Iodide doped with Thallium] | IDENTICAL | | Spatial<br>Resolution | 45% [MTF@2lp/mm] | 45% [MTF@2lp/mm] | IDENTICAL | | DQE | 67% [@0.5 lp/mm, 3.5 uGy] | 67% [@0.5 lp/mm, 3.5 uGy] | IDENTICAL | | IP Level | CXDI-720C Wireless: IP57<br>CXDI-420C Wireless: IP57<br>CXDI-420C Fixed: N/A | IP57 | MODIFIED | | Wireless<br>Communication | IEEE 802.11a/b/g/n/ac<br>2.4GHz/5GHz<br>Bluetooth Low Energy<br>(only for CXDI-720C Wireless and CXDI-420C<br>Wireless) | IEEE 802.11a/b/g/n/ac<br>2.4GHz/5GHz<br>Bluetooth Low Energy | IDENTICAL | | External<br>Dimensions | CXDI-720C Wireless: 384 x 460 x 15.5 mm<br>CXDI-420C Wireless: 460 x 460 x 15.5 mm<br>CXDI-420C Fixed: 460 x 460 x 15.3 mm | 384 x 460 x 15.5 mm | MODIFIED | | Photographing<br>Mode | Standard Synchronization Mode,<br>Standard Synchronization Mode with Built in AEC<br>Assistance,<br>Non Generator Connection Mode,<br>Standalone Mode (only for CXDI-720C Wireless and<br>CXDI-420C Wireless) | Standard Synchronization Mode,<br>Standard Synchronization Mode with<br>Built in AEC Assistance,<br>Non Generator Connection Mode,<br>Standalone Mode | MODIFIED | Summary of Non-Clinical / Test Data: The fundamental scientific technology of the CXDI-Elite has not been modified. The changes are the addition of new detectors CXDI-420C Wireless (AR-E4343W) and CXDI-420C Fixed (AR-E4343S); the addition of an optional accessory, the Detector Stand (DS-01); the update to the CXDI Control Software from 3.10.0.4 to 3.10.2.2; and the update to the detector firmware from 02.00.00.03 to F2.00.03.00. Evaluation of the addition of the new detector and optional accessories confirmed that the changes did not impact CXDI-Elite conformance 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, 60601-2-54, and 60601-1-6. These verification/validation activities successfully demonstrated that the device continues to meet the standards for the areas impacted by the modifications to the predicate device and raises no new questions regarding either safety or effectiveness when compared to the predicate device. Clinical testing is not necessary for the current submission, based on the minor differences from the predicate device. Adequate detector bench testing should be sufficient to demonstrate that the subject detector CXDI-Elite / E1 works as intended. Therefore, the verification/validation activities conducted support a determination of substantial equivalence for the CXDI-Elite. The proposed device follows the applicable elements of the following FDA guidance documents: Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices, Guidance for the Content of Premarket Submissions for Software contained in Medical Devices, Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", Radio Frequency Wireless Technology in Medical Devices, and Pediatric Information for X-ray Imaging Device Premarket Notifications. Canon Inc. considers the DIGITAL RADIOGRAPHY CXDI-Elite / E1 device to be Conclusion: substantially equivalent to the predicate device listed above. This conclusion is based on {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the word "Canon" in red font at the top. Below the word "Canon" is the text "510(k) SUMMARY" in black font. The text is centered below the word "Canon". The image appears to be a document header. the similarities in primary intended use, principles of operation, functional design, and established medical use.