Who is the manufacturer of DIGITAL RADIOGRAPHY CXDI-Pro, D1?

Canon, Inc. filed the 510(k) submission for DIGITAL RADIOGRAPHY CXDI-Pro, D1 (K212553).

What is the FDA product code for DIGITAL RADIOGRAPHY CXDI-Pro, 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, D1?

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

What are the predicate devices for DIGITAL RADIOGRAPHY CXDI-Pro, D1?

DIGITAL RADIOGRAPHY CXDI-710C (K170332).

Who can help prepare an FDA 510(k) submission like DIGITAL RADIOGRAPHY CXDI-Pro, 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, D1

K212553 · Canon, Inc. · MQB · Sep 9, 2021 · Radiology

Device Facts

Record ID	K212553
Device Name	DIGITAL RADIOGRAPHY CXDI-Pro, D1
Applicant	Canon, Inc.
Product Code	MQB · Radiology
Decision Date	Sep 9, 2021
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 via CsI(Tl) scintillator; converts to visible light; photodetector array generates electrical signals; signals converted to digital values. Used in general radiography; operated by clinicians/technicians. Communicates images to operator console via wired or wireless (IEEE 802.11/Bluetooth) connection for display on monitors. Facilitates diagnostic decision-making by providing digital radiographic images. Benefits include transition from film to digital workflow, enabling faster image review and storage.

Clinical Evidence

Bench testing only. No clinical data provided. Verification and validation activities confirmed conformance with U.S. Performance Standards for radiographic equipment and voluntary safety standards including IEC 60601-1, 60601-1-2, 60601-2-54, 60601-1-6, and IEC 60529.

Technological Characteristics

Solid-state X-ray imager; CsI(Tl) scintillator; 140μm pixel pitch; magnesium alloy case; IP55 rating. Connectivity: Wired, IEEE 802.11n/ac/a/g/b (2.4GHz/5GHz), and Bluetooth Low Energy. Software: CXDI Control Software V3.10. Power: Battery pack (LB-4A).

Indications for Use

Indicated for human anatomy radiographic image capture in general purpose diagnostic procedures, 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-710C (K170332)

Reference Devices

DIGITAL RADIOGRAPHY CXDI-702C (K192632)

Related Devices

K183286 — 17HK701G-W · Lg Electronics.Inc · Dec 7, 2018
K201932 — X-ray Flat Panel Detectors (CareView 1800Cwe /CareView 1500Cwe) · Careray Digital Medical System Co., Ltd. · Aug 7, 2020
K183713 — Wireless Digital Flat Detector · Iray Technology Taicang , Ltd. · Jan 9, 2019
K112309 — DIGITAL RADIOGRAPHY · Canon Inc. -Medical Equipment Group · Sep 2, 2011
K220098 — Digital Radiography CXDI-Pro, Digital Radiography D1 · Canon, Inc. · Feb 4, 2022

Submission Summary (Full Text)

{0}------------------------------------------------ September 30, 2021 Image /page/0/Picture/1 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The symbol on the left is a stylized representation of the Department of Health & Human Services seal. The text on the right is in blue, with "FDA" in a larger font size than the rest of the text. Canon Inc. % Mr. Gregory Woodard Biomedical Engineer Ken Block Consulting 800 East Campbell Road, Suite 202 RICHARDSON TX 75081 Re: K212553 Trade/Device Name: DIGITAL RADIOGRAPHY CXDI-Pro D1 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MOB Dear Gregory Woodard: The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated September 9, 2021. Specifically, FDA is updating this SE Letter (Typo in the Trade Name) as an administrative correction. Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Laurel Burk, OHT7: Office of In Vitro Diagnostics and Radiological Health, 301-796-5933, laurel.burk(@fda.hhs.gov. > Sincerely, Laurel M Burk -S Digitally signed by Laurel M. Burk -S Date: 2021.09.30 14:31:00 -04'00' 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 {1}------------------------------------------------ September 9, 2021 Image /page/1/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 and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. Canon Inc. % Mr. Gregory Woodard Biomedical Engineer Ken Block Consulting 800 East Campbell Road. Suite 202 RICHARDSON TX 75081 # Re: K212553 Trade/Device Name: DIGITAL RADIOGRAPHY CXDI-Pro, D1 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB Dated: August 12, 2021 Received: August 13, 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 {2}------------------------------------------------ 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(@tda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Image /page/2/Picture/5 description: The image shows a digital signature. The signature is from Laurel M. Burk -S. The date of the signature is 2021.09.09, and the time is 10:30:16 -04'00'. Thalia T. Mills, Ph.D. Director 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 {3}------------------------------------------------ # Indications for Use 510(k) Number (if known) K212553 Device Name DIGITAL RADIOGRAPHY CXDI-Pro 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) | |-------------------------------------------------| |-------------------------------------------------| | <input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | |----------------------------------------------------------------------------------| | <input type="checkbox"/> 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." {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the word "Canon" in a bold, red font. The letters are closely spaced together, creating a solid block of text. The logo is simple and recognizable, representing the well-known electronics company. # 5. 510(k) SUMMARY K212553 | Applicant/Sponsor: | Canon Inc. 30-2 Shimomaruko, 3-chrome Ohta-ku, Tokyo 146-8501 Japan | |---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Mr. Akira Hirai General Manager TEL: 81-3-3758-2111; FAX: 044-739-6695 hirai.akira@mail.canon | | Date Prepared: | August 12, 2021 | | Submission Type: | Special 510(k) Submission | | Proposed Device: | Manufacturer: Canon Inc. Trade Name: DIGITAL RADIOGRAPHY CXDI-Pro D1 Common Name: Solid State X-Ray Imager (Flat Panel/Digital Imager) Classification Name: Stationary X-ray System Classification: 892.1680, Stationary X-ray System Product Code: MQB | | Predicate Device: | 510k Number: K170332 Manufacturer: Canon Inc. Trade Name: DIGITAL RADIOGRAPHY CXDI-710C Common Name: Solid State X-ray Imager Classification Name: Stationary X-ray System Classification: 892.1680, Stationary X-ray System Product Code: MQB | | Reference Devices: | 510k Number: K192632 Manufacturer: Canon Inc. Trade Name: DIGITAL RADIOGRAPHY CXDI-702C Common Name: Solid State X-Ray Imager (Flat Panel/Digital Imager) Classification Name: Stationary X-ray System Classification: 892.1680, Stationary X-ray System Product Code: MQB | | Device Description: | The DIGITAL RADIOGRAPHY CXDI-Pro, also called the D1, (hereinafter referred to as CXDI-Pro) is a solid-state x-ray imager. The CXDI-Pro is a series of detectors, currently consisting of the CXDI-703C Wireless detector unit, also called the AR- D3543W 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, and the images will be displayed on monitors. The digital value can be communicated to the operator console via a wired or wireless connection. | {5}------------------------------------------------ | | The subject of this Special 510(k) submission is a change to the DIGITAL RADIOGRAPHY CXDI-710C Wireless (hereinafter referred to as CXDI-710C) to make the CXDI-Pro. This change will remove the Docking Station, Multi Box, and Status Indicator as optional components and add the X-ray Interface Box and Power Box as optional components. The software has been updated from CXDI Control Software V2.16 to CXDI Control Software V3.10. The case material has been changed from fiberglass to magnesium alloy. Bluetooth function has been added, and Standalone mode has been removed as a photographing mode. Together, these changes make up the CXDI-Pro. | |-------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indication for Use: | The Indication for Use statement is identical to the predicate device. The intended use of the modified device, as described in the labeling, has not changed as a result of the modification(s). 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. | | Summary of Technological Characteristics: | Comparison with the predicate devices shows the characteristics of the proposed modifications (changes to the optional accessories, software change from V2.16 to V3.10, change in case material from fiberglass to magnesium alloy, addition of Bluetooth, and removal of Standalone mode) to the CXDI-Pro to be substantially | | | Proposed Device | Predicate Device | Reference Devices | | |---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------| | Trade Name | DIGITAL RADIOGRAPHY CXDI-Pro / D1 | DIGITAL RADIOGRAPHY CXDI-710C | DIGITAL RADIOGRAPHY CXDI-702C | | | 510(k) Submitter [Number] | Canon Inc. [TBD] | Canon Inc. [K170332] | Canon, Inc. [K192632] | IDENTICAL | | Indication for 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. | 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 | 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 | 140μm | 125μm | 125μm | MODIFIED | | Spatial Resolution | 35% [MTF@2lp/mm] | 35% [MTF@2lp/mm] | 35% [MTF@2lp/mm] | IDENTICAL | | IP Level | IP55 | IPX7 | IP54 | MODIFIED | equivalent to the predicate device. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the word "Canon" in red font. The font is bold and slightly italicized. The word is easily readable and takes up most of the image. | Standard Components | Detector (Sensor), Battery Pack (LB-4A), Documentation (Manuals) | Detector (Sensor), Battery Pack (LB-4A), Documentation (Manuals) | Detector (Sensor), Battery Pack (LB-4A), Documentation (Manuals) | IDENTICAL | |---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------| | Optional Components | Battery Charger (BC-1A), 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) | Docking Station (DS-4A), Battery Charger (BC-1A), Battery Pack (LB-4A), Multi Box (MB-4A), Status Indicator (SI-4A), Wiring Cable (WC-4A), PC Connection Cable (CP-4A), Ready Indicator (RI-3A) | Docking Station (DS-4A), Battery Charger (BC-1A), Battery Pack (LB-4A), Multi Box (MB-4A), Status Indicator (SI-4A), Wiring Cable (WC-4A), PC Connection Cable (CP-4A), Ready Indicator (RI-3A), X-ray Interface Box (XB-1A) | MODIFIED | | Software | CXDI Control Software V3.10 | CXDI Control Software V2.16 | CXDI Control Software V2.19 | MODIFIED | | Photographing Mode | Standard Synchronization Mode, Non Generator Connection Mode | Standard Synchronization Mode, Non Generator Connection Mode, Standalone Mode | Standard Synchronization Mode, Non Generator Connection Mode | MODIFIED | | Wireless Communication | IEEE 802.11n/ac/a/g/b 2.4GHz/5GHz Bluetooth Low Energy | IEEE 802.11n 2.4GHz/5GHz | IEEE 802.11n/a/g/b 2.4GHz/5GHz | MODIFIED | The User's and Installation Manuals provide detailed instructions and information for safe and effective use of the device, and users are expected to adhere to the instructions and other information. The User's Manual explains how to use the detector and other equipment. Connected medical equipment, such as x-ray generators, must comply with IEC 60601-1. ### Performance: The fundamental scientific technology of the CXDI-Pro has not been modified. The changes are an update to the software in the CXDI-710C, changes to the optional accessories, change in case material from fiberglass to magnesium alloy, addition of Bluetooth, and removal of Standalone mode. Evaluation of the changes to the CXDI-710C 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, 60601-2-54, 60601-1-6, and IEC 60529. 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. Therefore, the verification/validation activities conducted support a determination of substantial equivalence for the CXDI-Pro. #### Canon Inc. considers the CXDI-Pro to be substantially equivalent to the predicate Conclusion: device listed above. This conclusion is based on the similarities in primary intended use, principles of operation, functional design, and established medical use.