The DIGITAL RADIOGRAPHY CXDI-Elite / E1 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 Description

The DIGITAL RADIOGRAPHY CXDI-Elite, also called the DIGITAL RADIOGRAPHY E1, (hereinafter referred to as CXDI-Elite) is a solid-state x-ray imager. The CXDI-Elite is a series of detectors, and in the predicate device consists of the CXDI-720C Wireless detector (also called the AR-E3543W detector), the CXDI- 420C Wireless detector (also called the AR-E4343W detector), and the CXDI-420C Fixed detector (also called the AR-E4343S detector). 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. The digital values are sent to the PC via a wired or wireless connection, converted to images with the CXDI Control Software, and then displayed on the PC/monitors. The PC/monitors used with the CXDI-Elite are not a part of this submission. The proposed changes to the predicate device, DIGITAL RADIOGRAPHY CXDI-Elite (K221620), include the addition of a new detector, the CXDI-820C Wireless (also called the AR-E2735W), to the CXDI-Elite series; the standardization of the thickness of CXDI-720C Wireless and CXDI-420C Wireless; the firmware update from F2.00.03.00 to 02.01.04.00; the CXDI Control Software version update from 3.10.2.2 to 3.10.2.6; and the addition of a 25 m of the CXDI-420C Fixed detector cable and a 10 m of Wiring Cable (WC-01). Together, these changes make up the CXDI-Elite.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Digital Radiography CXDI-Elite / E1, based on the provided text:

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than a comprehensive performance study of a novel device. Therefore, a traditional "study that proves the device meets the acceptance criteria" in terms of clinical outcomes or diagnostic accuracy with human-in-the-loop is expressly stated as not necessary for this submission. The "acceptance criteria" here are primarily about conformance to safety and performance standards after design changes, and the "study" is the verification/validation activities.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Conformance with U.S. Performance Standard for radiographic equipment	The evaluation confirmed that the changes (addition of new detector, firmware, software updates) did not impact CXDI-Elite conformance with the U.S. Performance Standard for radiographic equipment.
Conformance with relevant voluntary safety standards for Electrical safety	The evaluation confirmed that the changes did not impact CXDI-Elite conformance with relevant voluntary safety standards for Electrical safety, specifically IEC 60601-1, 60601-1-3, and 60601-2-54.
Conformance with relevant voluntary safety standards for Electromagnetic Compatibility (EMC)	The evaluation confirmed that the changes did not impact CXDI-Elite conformance with relevant voluntary safety standards for Electromagnetic Compatibility, specifically IEC 60601-1-2.
Conformance with relevant voluntary safety standards for Usability	The evaluation confirmed that the changes did not impact CXDI-Elite conformance with relevant voluntary safety standards for Usability, specifically IEC 60601-1-6.
Device works as intended	Adequate detector bench testing successfully demonstrated that the subject detector CXDI-Elite / E1 works as intended. The verification/validation activities conducted support a determination of substantial equivalence, indicating the device performs as expected for its intended use (digital image capture for conventional film/screen radiographic examinations, replacing film/screen systems in general purpose diagnostic procedures, not for mammography). No new questions regarding safety or effectiveness were raised compared to the predicate device.
Substantial Equivalence to Predicate Device (K221620)	Achieved, based on similarities in primary intended use, principles of operation, functional design, and established medical use.

Study Details:

This submission describes verification/validation activities rather than a clinical study.

Sample size used for the test set and the data provenance: Not applicable in the context of a clinical test set. The submission refers to "adequate detector bench testing" and "verification/validation activities" which would involve testing the device itself against various parameters and standards. No specific number of images or patient data is mentioned for testing in the summary provided. The focus is on the device's technical performance and safety, not diagnostic accuracy based on a dataset.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for diagnostic decision-making from expert interpretation is not relevant for this type of submission, as it's not a diagnostic AI device requiring human reader comparison. The "ground truth" here is compliance with engineering specifications and regulatory standards, established through technical testing.
Adjudication method for the test set: Not applicable. As there were no human readers establishing ground truth for diagnostic accuracy, no adjudication method was used.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a general-purpose digital radiography system, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Yes, in terms of product performance and safety, the device itself was evaluated in a standalone manner (through bench testing and compliance checks). The "device works as intended" conclusion stems from this.
The type of ground truth used:
- Engineering specifications and performance standards: For parameters like pixel pitch, scintillator type, spatial resolution, IP level, wireless communication, and physical dimensions.
- Regulatory standards: IEC 60601-1, 60601-1-2, 60601-1-3, 60601-2-54, 60601-1-6, and the U.S. Performance Standard for radiographic equipment.
The sample size for the training set: Not applicable. This document does not describe the development of an AI algorithm, so there is no "training set."
How the ground truth for the training set was established: Not applicable, as there is no training set for an AI algorithm mentioned.

Summary

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September 29, 2022

Image /page/0/Picture/1 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.

Canon Inc. % Ms. Saori Sawaki Business Manager, Regulatory Consultant Ken Block Consulting LLC 800 E Campbell Road. Suite 202 RICHARDSON TX 75081

Re: K222687

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: September 6, 2022 Received: September 6, 2022

Dear Ms. Saori Sawaki:

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.

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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 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 (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 DHT8B: Division of Imaging Devices and Electronic Products OHT8: Office of 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)

K222687

Device Name DIGITAL RADIOGRAPHY CXDI-Elite DIGITAL RADIOGRAPHY E1

Indications for Use (Describe)

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

Research Use (R, 21 CFR 821 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart G)

Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/3/Picture/1 description: The image shows the word "Canon" in 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 word "Canon".

Applicant/Sponsor:	Canon Inc. 9-1 Imaikami-cho Nakahara-ku, Kanagawa 211-8501 JAPAN
Contact Person:	Mr. Akira Hirai General Manager TEL: 81-3-3758-2111 FAX: 044-739-6695 hirai.akira@mail.canon
Date Prepared:	September 15, 2022
Proposed Device	Manufacturer: Canon Inc.Trade Name: DIGITAL RADIOGRAPHY CXDI-Elite DIGITAL RADIOGRAPHY E1
	Common Name: Solid State X-Ray Imager (Flat Panel/Digital Imager)Classification Name: Stationary X-ray SystemProduct Code: MQBRegulation: 892.1680, Stationary X-ray System
Predicate Device:	Clearance: K221620Manufacturer: Canon Inc.Trade Name: DIGITAL RADIOGRAPHY CXDI-Elite DIGITAL RADIOGRAPHY E1
	Common Name: Solid State X-ray Imager (Flat Panel/Digital Imager)Classification Name: Stationary X-ray SystemProduct Code: MQBRegulation: 892.1680, Stationary X-ray System
Device Description:	The DIGITAL RADIOGRAPHY CXDI-Elite, also called the DIGITAL RADIOGRAPHY E1, (hereinafter referred to as CXDI-Elite) is a solid-state x-ray imager. The CXDI-Elite is a series of detectors, and in the predicate device consists of the CXDI-720C Wireless detector (also called the AR-E3543W detector), the CXDI- 420C Wireless detector (also called the AR-E4343W detector), and the CXDI-420C Fixed detector (also called the AR-E4343S detector). 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. The digital values are sent to the PC via a wired or wireless connection, converted to images with the CXDI Control Software, and then displayed on the PC/monitors. The PC/monitors used with the CXDI-Elite are not a part of this submission. The proposed changes to the predicate device, DIGITAL RADIOGRAPHY CXDI-Elite (K221620), include the addition of a new detector, the CXDI-820C Wireless (also called the AR-E2735W), to the CXDI-Elite series; the standardization of the thickness of CXDI-720C Wireless and CXDI-420C Wireless; the firmware update from F2.00.03.00 to 02.01.04.00; the CXDI Control Software version update from 3.10.2.2 to 3.10.2.6; and the addition of a 25 m of the CXDI-420C Fixed detector cable and a 10 m of Wiring Cable (WC-01). Together, these changes make up the CXDI-Elite.

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Image /page/4/Picture/0 description: The image shows the Canon logo in red, followed by the text "510(k) SUMMARY" in bold black font. The Canon logo is a stylized version of the company's name. The text "510(k) SUMMARY" is likely a reference to a regulatory document related to medical devices. The image is simple and straightforward, with a clear focus on the Canon brand and the regulatory context.

The DIGITAL RADIOGRAPHY CXDI-Elite / E1 provides digital image capture for Indications for Use: 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 technological characteristics of the Technological CXDI-Elite is substantially equivalent to the predicate device. The flat panel detector Characteristics: units are functionally same, using the same components.

	Proposed Device	Predicate Device
Trade Name	DIGITAL RADIOGRAPHY CXDI-Elite / E1	DIGITAL RADIOGRAPHY CXDI-Elite / E1
510(k) Submitter[Number]	Canon Inc.[K222687]	Canon Inc.[K221620]	IDENTICAL
Indication for Use	The DIGITAL RADIOGRAPHY CXDI-Elite /E1 provides digital image capture forconventional film/screen radiographicexaminations. This device is intended to capture,for display, radiographic images of humananatomy, and to replace radiographicfilm/screen systems in all general purposediagnostic procedures. This device is notintended for mammography applications.	The DIGITAL RADIOGRAPHY CXDI-Elite /E1 provides digital image capture forconventional film/screen radiographicexaminations. This device is intended to capture,for display, radiographic images of humananatomy, and to replace radiographicfilm/screen systems in all general purposediagnostic procedures. This device is notintended for mammography applications.	IDENTICAL
Application	General Radiography	General Radiography	IDENTICAL
Detector	CXDI-720C Wireless (AR-E3543W)CXDI-420C Wireless (AR-E4343W)CXDI-820C Wireless (AR-E2735W)CXDI-420C Fixed (AR-E4343S)	CXDI-720C Wireless (AR-E3543W)CXDI-420C Wireless (AR-E4343W)CXDI-420C Fixed (AR-E4343S)	MODIFIED
Components	CXDI-720C Wireless,CXDI-420C Wireless, andCXDI-820C Wireless:Detector (Sensor)Battery Pack (LB-4A)Battery Charger (BC-01/BC-1A)Multi Box (MB-02)Status Indicator (SI-01/SI-4A)Wiring Cable, 1.5/7.5/10/15/25m (WC-01)PC Connection Cable (CP-01)Ready Indicator (RI-3A)X-ray Interface Box (XB-1A)Detector Stand (DS-01)CXDI-420C Fixed:Detector (Sensor)Multi Box (MB-02)Status Indicator (SI-01/SI-4A)Ready Indicator (RI-3A)X-ray Interface Box (XB-1A)	CXDI-720C Wireless andCXDI-420C Wireless:Detector (Sensor)Battery Pack (LB-4A)Battery Charger (BC-01/BC-1A)Multi Box (MB-02)Status Indicator (SI-01/SI-4A)Wiring Cable, 1.5/7.5/15/25m (WC-01)PC Connection Cable (CP-01)Ready Indicator (RI-3A)X-ray Interface Box (XB-1A)Detector Stand (DS-01)CXDI-420C Fixed:Detector (Sensor)Multi Box (MB-02)Status Indicator (SI-01/SI-4A)Ready Indicator (RI-3A)X-ray Interface Box (XB-1A)	MODIFIED
Other CompatibleComponents	Power Box (PB-01)	Power Box (PB-01)	IDENTICAL
Software	CXDI Control Software V3.10.2.6	CXDI Control Software V3.10.2.2	MODIFIED
Detector Firmware	02.01.04.00	F2.00.03.00	MODIFIED
Pixel Pitch	125µm	125µm	IDENTICAL
Scintillator	CsI(Tl)[Cesium Iodide doped with Thallium]	CsI(Tl)[Cesium Iodide doped with Thallium]	IDENTICAL
SpatialResolution	45% [MTF@2lp/mm]	45% [MTF@2lp/mm]	IDENTICAL
IP Level	CXDI-720C Wireless: IP57CXDI-420C Wireless: IP57CXDI-820C Wireless: IP57CXDI-420C Fixed: N/A	CXDI-720C Wireless: IP57CXDI-420C Wireless: IP57CXDI-420C Fixed: N/A	MODIFIED
WirelessCommunication	IEEE 802.11a/b/g/n/ac2.4GHz/5GHzBluetooth Low Energy(only for CXDI-720C Wireless, CXDI-420CWireless, and CXDI-820C Wireless)	IEEE 802.11a/b/g/n/ac2.4GHz/5GHzBluetooth Low Energy(only for CXDI-720C Wireless and CXDI-420CWireless)	IDENTICAL
ExternalDimensions	CXDI-720C Wireless: 384 x 460 x 15.7 mmCXDI-420C Wireless: 460 x 460 x 15.7 mmCXDI-820C Wireless: 384 x 307.5 x 15.7mmCXDI-420C Fixed: 460 x 460 x 15.3 mm	CXDI-720C Wireless: 384 x 460 x 15.5 mmCXDI-420C Wireless: 460 x 460 x 15.5 mmCXDI-420C Fixed: 460 x 460 x 15.3 mm	MODIFIED
PhotographingMode	Standard Synchronization Mode,Standard Synchronization Mode with Built inAEC Assistance,Non Generator Connection Mode,Standalone Mode (only for CXDI-720CWireless, CXDI-420C Wireless, and CXDI-820C Wireless)	Standard Synchronization Mode,Standard Synchronization Mode with Built inAEC Assistance,Non Generator Connection Mode,Standalone Mode (only for CXDI-720CWireless and CXDI-420C Wireless)	IDENTICAL

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Image /page/5/Picture/0 description: The image shows the word "Canon" in a large, red, bold font. Below the word "Canon" is the text "510(k) SUMMARY" in a smaller, black, bold font. The text is centered below the word "Canon".

Summary of Non-Clinical / Test Data:

The fundamental scientific technology of the CXDI-Elite has not been modified. The change is the addition of new detector CXDI-820C Wireless (AR-E2735W).

Evaluation of the addition of the new detector confirmed that the change 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, 60601-1-3, 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 the similarities in primary intended use, principles of operation, functional design, and established medical use.

Regulation Number and Section

§ 892.1680 Stationary x-ray system.

(a)
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.(b)
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.