Who is the manufacturer of DIGITAL RADIOGRAPHY CXDI-Elite, DIGITAL RADIOGRAPHY E1?

Canon, Inc. filed the 510(k) submission for DIGITAL RADIOGRAPHY CXDI-Elite, DIGITAL RADIOGRAPHY E1 (K213780).

What is the FDA product code for DIGITAL RADIOGRAPHY CXDI-Elite, DIGITAL RADIOGRAPHY E1?

MQB. It is classified under 21 CFR 892.1680 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for DIGITAL RADIOGRAPHY CXDI-Elite, DIGITAL RADIOGRAPHY E1?

510(k) clearance (submission type: Traditional).

What are the predicate devices for DIGITAL RADIOGRAPHY CXDI-Elite, DIGITAL RADIOGRAPHY E1?

DIGITAL RADIOGRAPHY CXDI-710C Wireless (K170332).

Who can help prepare an FDA 510(k) submission like DIGITAL RADIOGRAPHY CXDI-Elite, DIGITAL RADIOGRAPHY E1?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

DIGITAL RADIOGRAPHY CXDI-Elite, DIGITAL RADIOGRAPHY E1

K213780 · Canon, Inc. · MQB · Jan 24, 2022 · Radiology

Device Facts

Record ID	K213780
Device Name	DIGITAL RADIOGRAPHY CXDI-Elite, DIGITAL RADIOGRAPHY E1
Applicant	Canon, Inc.
Product Code	MQB · Radiology
Decision Date	Jan 24, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1680
Device Class	Class 2

Intended Use

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 Story

Solid-state X-ray imager (flat panel detector) using TFT arrays; intercepts X-ray photons via Cesium-Iodide scintillator; converts visible light to electrical signals; generates digital images for display on monitors. Used in clinical settings by healthcare professionals for general radiography. Device communicates via wired or wireless connection to operator console. Software (CXDI Control Software V3.10) manages image acquisition, calibration, and synchronization with X-ray generators. Includes 'Intelligent NR' function and 'Standard Synchronization Mode with Built in AEC Assistance'. Output allows clinicians to view radiographic images for diagnostic decision-making, replacing traditional film/screen systems.

Clinical Evidence

No clinical data. Bench testing only. Verification and validation testing included functional specifications, software testing, and non-clinical image comparisons. Compliance with IEC 60601-1, 60601-1-2, 60601-1-3, 60601-1-6, 60601-2-54, and IEC 60529 (IP57) confirmed. DQE performance measured at 0.67 (at 3.5uGy, 0.5 lp/mm).

Technological Characteristics

Solid-state TFT flat panel detector; CsI(Tl) scintillator; 125μm pixel pitch. Magnesium alloy/fiberglass housing. Wireless (IEEE 802.11a/b/g/n/ac, Bluetooth LE) and wired connectivity. IP57 ingress protection. Software-controlled image acquisition. Complies with IEC 60601-1, 60601-1-2, 60601-1-3, 60601-1-6, 60601-2-54.

Indications for Use

Indicated for digital image capture for conventional film/screen radiographic examinations of human anatomy in general purpose diagnostic procedures. Not intended 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-702C Wireless (K192632)

Related Devices

K221620 — Digital Radiography CXDI-Elite, Digital Radiography E1 · Canon, Inc. · Jun 14, 2022
K222855 — Digital Radiography CXDI-Pro, Digital Radiography D1 · Canon, Inc. · Oct 17, 2022
K221876 — Digital Radiography CXDI-Pro, Digital Radiography D1 · Canon, Inc. · Jul 15, 2022
K222661 — Digital Radiography CXDI-CS01 · Canon, Inc. · Sep 27, 2022
K220098 — Digital Radiography CXDI-Pro, Digital Radiography D1 · Canon, Inc. · Feb 4, 2022

Submission Summary (Full Text)

{0}------------------------------------------------ January 24, 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below that. Canon Inc. % Mr. Gregory Woodard Biomedical Engineer Ken Block Consulting 800 East Campbell Road, Suite 202 RICHARDSON TX 75081 Re: K213780 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: December 2, 2021 Received: December 3, 2021 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 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 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K213780 Device Name DIGITAL RADIOGRAPHY CXDI-Elite DIGITAL RADIOGRAPHY E1 #### Indications for Use (Describe) 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. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------| | <label><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> | <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> | 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}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the word "Canon" in a large, bold, red font. Below the word "Canon" is the text "5. 510(k) SUMMARY" in a smaller, black font. The text is left-aligned and the background is white. | K213780 | | | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--| | 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: | December 2, 2021 | | | 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 System Product Code: MQB Regulation: 892.1680, Stationary X-ray System | | | Predicate Device: | Clearance: K170332 Manufacturer: Canon Inc. Trade Name: DIGITAL RADIOGRAPHY CXDI-710C Wireless Common Name: Solid State X-ray Imager (Flat Panel/Digital Imager) Classification Name: Stationary X-ray System Product Code: MQB Regulation: 892.1680, Stationary X-ray System | | | Reference Device: | Clearance: K192632 Manufacturer: Canon Inc. Trade Name: DIGITAL RADIOGRAPHY CXDI-702C Wireless Common Name: Solid State X-ray Imager (Flat Panel/Digital Imager) Classification Name: Stationary X-ray System Product Code: MQB Regulation: 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 using TFT (thin-film transistor) arrays. The CXDI-Elite is a series of detectors, currently consisting of the CXDI-720C Wireless detector unit, also called the AR- E3543W detector. The detector intercepts x-ray photons, and the Cesium-Iodide 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 a digital image, and the images will be displayed on monitors. The digital image can be communicated to the operator console via a wired or wireless connection. The monitors used with the CXDI-Elite are not a part of this submission. The CXDI Control Software is updated from V2.16 to V3.10 in this submission. The update to the software includes bug fixes, modification to check-in function, | | | K213780 | modification to communication with X-ray emission devise, calibration support, addition of the Intelligent NR function (previously cleared under K212269), and the addition of Standard Synchronization Mode with Built in AEC Assistance. | | | Indications for Use: | 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. | | | Summary of Technological Characteristics: | Comparison with the predicate device shows the technological characteristics of the CXDI-Elite is substantially equivalent to the predicate device. The flat panel detector units are functionally similar, but the proposed device adds Standard Synchronization Mode with Built in AEC Assistance as a photographing mode. | | | 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. | | | {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the Canon logo in red, followed by the text "5. 510(k) SUMMARY" in black. The Canon logo is a stylized version of the company's name. The text below the logo appears to be a section heading or title, possibly from a document or report. The text is in a bold font and is left-aligned. | | Proposed Device | Predicate Device | Reference Devices | | |---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------| | Trade Name | DIGITAL RADIOGRAPHY CXDI-Elite / E1 | DIGITAL RADIOGRAPHY CXDI-710C Wireless | DIGITAL RADIOGRAPHY CXDI-702C Wireless | | | 510(k) Submitter [Number] | Canon Inc. [K213780] | Canon Inc. [K170332] | Canon Inc. [K192632] | IDENTICAL | | Indication for Use | 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. | The DIGITAL RADIOGRAPHY CXDI-710C 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. | The DIGITAL RADIOGRAPHY CXDI-702C 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. | IDENTICAL | | Application | General Radiography | General Radiography | General Radiography | IDENTICAL | | Case Material | Magnesium alloy/ Fiberglass | Fiberglass | Magnesium Alloy | MODIFIED | | Scintillator | CsI(TI) [Cesium Iodide doped with Thallium] | CsI(TI) [Cesium Iodide doped with Thallium] | CsI(TI) [Cesium Iodide doped with Thallium] | IDENTICAL | | Pixel Pitch | 125μm | 125μm | 125μm | IDENTICAL | | Spatial Resolution | 45% [MTF@2lp/mm] | 35% [MTF@2lp/mm] | 35% [MTF@2lp/mm] | IDENTICAL | | IP Level | IP57 | IPX7 | IP54 | MODIFIED | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the word "Canon" in a large, bold, red font. Below the word "Canon" is the text "5. 510(k) SUMMARY" in a smaller, bold, black font. The text is centered below the word "Canon". #### K213780 | Components | Detector (Sensor) | Detector (Sensor) | Detector (Sensor) | MODIFIED | |---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|-----------| | | Battery Pack (LB-4A) | Battery Pack (LB-4A) | Battery Pack (LB-4A) | | | | Battery Charger (BC-01/BC-1A) | Battery Charger (BC-1A) | Battery Charger (BC-1A) | | | | Multi Box (MB-02) | Multi Box (MB-4A) | Multi Box (MB-4A) | | | | Status Indicator (SI-01/SI-4A) | Status Indicator (SI-4A) | Status Indicator (SI-4A) | | | | Wiring Cable (WC-01) | Wiring Cable (WC-4A) | Wiring Cable (WC-4A) | | | | PC Connection Cable (CP-01) | PC Connection Cable (CP-4A) | PC Connection Cable (CP-4A) | | | | Ready Indicator (RI-3A) | Ready Indicator (RI-3A) | Ready Indicator (RI-3A) | | | | X-ray Interface Box (XB-1A) | Docking Station (DS-4A) | X-ray Interface Box (XB-1A) Docking Station (DS-4A) | | | Software | CXDI Control Software V3.10 | CXDI Control Software V2.16 | CXDI Control Software V2.19 | MODIFIED | | External Dimensions | 384 x 460 x 15.5 mm | 384 x 460 x 15.7 mm | 384 x 460 x 15.7 mm | MODIFIED | | DQE | A typical DQE value at 3.5uGy in 0.5 lp/mm is 0.67, with measurement error of less than ±10%. | A typical DQE value at 4 $\mu$ Gy in 0 lp/mm is 0.6. The level of uncertainty is estimated as less than ±10%. | A typical DQE value at 1 mR in 0.5 lp/mm is 0.58. The level of uncertainty is estimated as less than ±10%. | MODIFIED | | Detector Technology | TFT | TFT | TFT | IDENTICAL | | Photographing Mode | Standard Synchronization Mode, Standard Synchronization Mode with Built in AEC Assistance, Non Generator Connection Mode, Standalone Mode | Standard Synchronization Mode, Non Generator Connection Mode, Standalone Mode | Standard Synchronization Mode, Non Generator Connection Mode | MODIFIED | | Wireless Communication | IEEE 802.11a/b/g/n/ac 2.4GHz/5GHz Bluetooth Low Energy | IEEE 802.11n 2.4GHz/5GHz | IEEE 802.11n/a/g/b 2.4GHz/5GHz | MODIFIED | ## Summary of Non-Clinical / Test Data: Tests were performed on the device which demonstrated that the device is safe and effective, performs comparably to and is substantially equivalent to the predicate device. Tests included verification/validation testing to internal functional specifications (including software) and non-clinical image comparisons. Documentation was provided demonstrating compliance of the CXDI-Elite to all FDA requirements stated in Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, including results of verification/validation plus traceability of verification/validation tests to software requirements and software risk hazards. Other FDA guidance documents used in development include Content of Premarket Submissions for Management of Cybersecurity in Medical Devices. Documentation was provided demonstrating that the device complies with the FDA requirements stated in Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices. The evaluations of the device, compared to the predicate, show the device to be equivalent to the predicate. Testing confirmed that the device complies 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, 60601-1-6, and 60601-2-54. An IP Code of IP57 has been established for the CXDI-Elite per IEC 60529. 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. Together, these verification/validation activities successfully demonstrated that the device correctly performs as designed, has been validated for its intended use, and raises no new questions regarding either safety or effectiveness when compared to the {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the word "Canon" in a large, red, bold font at the top. Below the word "Canon" is the text "5. 510(k) SUMMARY" in a smaller, black, bold font. The text is aligned to the left and appears to be part of a document or report. The image is simple and contains only text. ## K213780 predicate device. Therefore, the verification/validation testing conducted supports a determination of substantial equivalence for the device. - Company considers the DIGITAL RADIOGRAPHY CXDI-Elite / E1 device to be Conclusion: 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.