Who is the manufacturer of Digital Radiography CXDI-Pro, Digital Radiography D1?

Canon, Inc. filed the 510(k) submission for Digital Radiography CXDI-Pro, Digital Radiography D1 (K221876).

What is the FDA product code for Digital Radiography CXDI-Pro, Digital Radiography D1?

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-Pro, Digital Radiography D1?

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

Who can help prepare an FDA 510(k) submission like Digital Radiography CXDI-Pro, Digital Radiography D1?

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-Pro, Digital Radiography D1

K221876 · Canon, Inc. · MQB · Jul 15, 2022 · Radiology

Device Facts

Record ID	K221876
Device Name	Digital Radiography CXDI-Pro, Digital Radiography D1
Applicant	Canon, Inc.
Product Code	MQB · Radiology
Decision Date	Jul 15, 2022
Decision	SESE
Submission Type	Special
Regulation	21 CFR 892.1680
Device Class	Class 2

Intended Use

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.

Device Story

Solid-state X-ray imager (flat panel detector) captures X-ray photons; scintillator (CsI(Tl)) converts to visible light; photodetector array generates electrical signals; signals converted to digital values. Data transmitted via wired/wireless connection to PC; CXDI Control Software processes and displays images. Used in clinical settings by healthcare professionals for general radiography. Device includes detectors, battery, interface/power boxes, and optional Multi Box/Status Indicator. Output provides diagnostic images for physician review to support clinical decision-making.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, verification, and validation activities confirming compliance with performance and safety standards (IEC 60601-1, 60601-1-2, 60601-1-6, 60601-2-54).

Technological Characteristics

Solid-state detector with CsI(Tl) scintillator and TFT array. Magnesium alloy case. Pixel pitch 140um. Wireless connectivity (IEEE 802.11n/ac/a/g/b, Bluetooth LE). IP55 rating. Software-based image processing. Complies with IEC 60601-1, 60601-1-2, 60601-1-6, 60601-2-54.

Indications for Use

Indicated for digital image capture of human anatomy for general purpose diagnostic radiographic examinations, replacing film/screen systems. 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-Pro / DIGITAL RADIOGRAPHY D1 (K220098)

Reference Devices

DIGITAL RADIOGRAPHY CXDI-Elite (K213780)

Related Devices

K222855 — Digital Radiography CXDI-Pro, Digital Radiography D1 · Canon, Inc. · Oct 17, 2022
K221620 — Digital Radiography CXDI-Elite, Digital Radiography E1 · Canon, Inc. · Jun 14, 2022
K222661 — Digital Radiography CXDI-CS01 · Canon, Inc. · Sep 27, 2022
K203849 — General Radiography CXDI-CS01 · Canon, Inc. · Jan 26, 2021
K213780 — DIGITAL RADIOGRAPHY CXDI-Elite, DIGITAL RADIOGRAPHY E1 · Canon, Inc. · Jan 24, 2022

Submission Summary (Full Text)

{0}------------------------------------------------ July 15, 2022 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. % Saori Sawaki Business Manager, Regulatory Consultant Ken Block Consulting 800 E. Campbell Road, Suite 202 RICHARDSON TX 75081 Re: K221876 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: June 27, 2022 Received: June 28, 2022 Dear 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. 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 {1}------------------------------------------------ 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 (OS) 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 OHT 8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Radiological Health Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) #### K221876 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) | | |-------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------| | X 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}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the word "Canon" in a bold, red font. The word is slightly blurred, giving it a sense of depth. Below the word "Canon" is the text "510(-) SUMMARY", which is smaller and in a different font. | STU(K) SUMMAK Y | | |-----------------|--| | | | | 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: June 27, 2022 Submission Type: Special 510(k) Submission | Proposed Device | Manufacturer: | Canon Inc. DIGITAL RADIOGRAPHY CXDI-Pro DIGITAL RADIOGRAPHY D1 | | | |------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|--|--| | | 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: | K220098 | | | | | Manufacturer: | Canon Inc. | | | | | Trade Name: | DIGITAL RADIOGRAPHY CXDI-Pro DIGITAL RADIOGRAPHY D1 | | | | | 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-Pro, also called the DIGITAL RADIOGRAPHY D1, (hereinafter referred to as CXDI-Pro) is a solid-state x-ray imager. The CXDI-Pro is a series of detectors, and in the predicate device (K220098) consists of the CXDI-703C Wireless and CXDI-403C Wireless detectors, also called the AR-D3543W and AR-D4343W detectors respectively. The detectors intercept 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-Pro are not a part of this submission. | | | | | | The subject of this Special 510(k) submission is a change to the predicate device, including compatibility with the Multi Box and Status Indicator, DIGITAL RADIOGRAPHY CXDI-Elite components that were cleared under K213780. The Status Indicator can be used when the proposed device is used in combination with the Multi Box. In addition, the CXDI Control Software has been updated from V3.10.0.8 to V3.10.2.2 to fix some bugs. Together, these changes make up the CXDI-Pro. | | | | {4}------------------------------------------------ Image /page/4/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". | Indications for 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. | |-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Summary of Technological Characteristics: | Comparison with the predicate device shows the technological characteristics of the CXDI-Pro is substantially equivalent to the predicate device. | | | The major differences between the CXDI-Pro and the predicate are differences in the components and a newer version of the CXDI control software. The proposed indications for use statement is identical to the indications for use statement of the | predicate device. | | Proposed Device | | Predicate Device | | | |--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|-----------| | Trade Name | DIGITAL RADIOGRAPHY CXDI-Pro / D1 | | DIGITAL RADIOGRAPHY CXDI-Pro / D1 | | | | 510(k) Submitter [Number] | Canon Inc. [TBD] | | Canon Inc. [K220098] | | IDENTICAL | | Indication for 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. | | 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. | | IDENTICAL | | Application | General Radiography | | | General Radiography | | | Components | Detector (Sensor) Documentation (Manuals) Battery Charger (BC-1A/BC-01) Battery Pack (LB-4A) X-ray Interface Box (XB-1A) Power Box (PB-01) Wiring Cable (WC-01) PC Connection Cable (CP-01) Ready Indicator (RI-3A) Detector Stand (DS-01) | | Detector (Sensor) Documentation (Manuals) Battery Charger (BC-1A/BC-01) Battery Pack (LB-4A) X-ray Interface Box (XB-1A) Power Box (PB-01) Wiring Cable (WC-01) PC Connection Cable (CP-01) Ready Indicator (RI-3A) Detector Stand (DS-01) | | IDENTICAL | | Other Compatible Components | Multi Box (MB-02) Status Indicator (SI-01/SI-4A) | | N/A | | MODIFIED | | Detector Sensor | CXDI-703C Wireless AR-D3543W | CXDI-403C Wireless AR-D4343W | CXDI-703C Wireless AR-D3543W | CXDI-403C Wireless AR-D4343W | IDENTICAL | | External Dimensions | 384 x 460 x 15.5 mm | 460 x 460 x 15.7 mm | 384 x 460 x 15.5 mm | 460 x 460 x 15.7 mm | IDENTICAL | | Case Material | Magnesium alloy | | Magnesium alloy | | IDENTICAL | | Detector Technology | TFT | | TFT | | IDENTICAL | | Pixel Pitch | 140um | | 140μm | | IDENTICAL | | Scintillator | CsI(Tl) [Cesium Iodide doped with Thallium] | | CsI(Tl) [Cesium Iodide doped with Thallium] | | IDENTICAL | | Spatial Resolution | 35% [MTF@2lp/mm] | | 35% [MTF@2lp/mm] | | IDENTICAL | | DQE | 58% [@0.5 lp/mm, 3.5 uGy] | | 58% [@0.5 lp/mm, 3.5 uGy] | | IDENTICAL | | IP Level | IP55 | | IP55 | | IDENTICAL | | Software | CXDI Control Software V3.10.2.2 | | CXDI Control Software V3.10.0.8 | | MODIFIED | | Wireless Communication | IEEE 802.11n/ac/a/g/b 2.4GHz/5GHz Bluetooth Low Energy | | IEEE 802.11n/ac/a/g/b 2.4GHz/5GHz Bluetooth Low Energy | | IDENTICAL | | Photographing Mode | Standard Synchronization Mode, Non Generator Connection Mode | | Standard Synchronization Mode, Non Generator Connection Mode | | IDENTICAL | {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the word "Canon" in a large, red, bold font. Below that, the words "510(k) SUMMARY" are printed in a smaller, black, bold font. The text is centered on the image. | Summary of Non-Clinical / Test Data: | The fundamental scientific technology of the CXDI-Pro has not been modified. The changes are the addition of optional accessories, a Multi Box and Status Indicator; the update to the detector firmware from 01.00.02.00 to 01.01.03.00; and the update to the CXDI Control Software from 3.10.0.8 to 3.10.2.2. | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Evaluation of the addition of the new detector and optional accessories confirmed that the changes did not impact CXDI-Pro 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, 60601-1-6, and 60601-2-54. | | | 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 verification and validation activities should be sufficient to demonstrate that the CXDI-Pro works as intended. Therefore, the verification/validation activities conducted support a determination of substantial equivalence for the CXDI-Pro. | | | 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, and Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process." | | | Conclusion: | Canon Inc. considers the DIGITAL RADIOGRAPHY CXDI-Pro / D1 to be 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. |