Digital Radiography CXDI-CS01

K230175 · Canon, Inc. · MQB · Feb 15, 2023 · Radiology

Device Facts

• Record ID: K230175
• Device Name: Digital Radiography CXDI-CS01
• Applicant: Canon, Inc.
• Product Code: MQB · Radiology
• Decision Date: Feb 15, 2023
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1680
• Device Class: Class 2

Intended Use

The DIGITAL RADIOGRAPHY CXDI-CS01 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 detector system; captures X-ray photons via scintillator (CsI(Tl)); converts visible light to electrical signals via photodetector array; converts signals to digital values. Data transmitted via wired/wireless connection to PC; processed by CXDI Control Software; displayed on monitors. Used in clinical settings by healthcare professionals. Output provides radiographic images for diagnostic decision-making; facilitates patient diagnosis by replacing film-based systems. Subject of submission: addition of CXDI-803C Wireless (Pro), CXDI-820C Wireless, and CXDI-420C Wireless (Elite) detectors; firmware updates; CXDI Control Software update (V3.10.2.6).

Clinical Evidence

Bench testing only. No clinical data provided. Verification and validation activities, including electrical safety, electromagnetic compatibility, and performance testing per IEC standards (60601-1, 60601-1-2, 60601-1-3, 60601-1-6, 60601-2-54, 62220-1, 62304, 62366), demonstrated substantial equivalence.

Technological Characteristics

Solid-state X-ray imager; CsI(Tl) scintillator; 125-140μm pixel pitch; wireless (IEEE 802.11a/b/g/n/ac, Bluetooth LE) or wired connectivity. IP ratings vary by model (IP54, IP55, IP57, IPX7). Software-based image processing. Complies with IEC 60601-1, 60601-1-2, 60601-1-3, 60601-2-54, 62220-1, 62304, 62366.

Indications for Use

Indicated for digital image capture of human anatomy for general purpose diagnostic radiographic procedures, replacing conventional film/screen systems. Not indicated 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-CS01 (K222661)

Submission Summary (Full Text)

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February 15, 2023

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

Re: K230175

Trade/Device Name: Digital Radiography CXDI-CS01 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary X-Ray System Regulatory Class: Class II Product Code: MQB Dated: January 20, 2023 Received: January 20, 2023

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 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

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Lu Jiang

Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiological 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) K230175

Device Name DIGITAL RADIOGRAPHY CXDI-CS01

Indications for Use (Describe)

The DIGITAL RADIOGRAPHY CXDI-CS01 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) | <table><tr><td>Prescription Use (Part 21 CFR 201 Subpart D)</td><td>Over-The-Counter Use (21 CFR 201 Subpart G)</td></tr><tr><td><div> <input checked="true" type="checkbox"/> </div></td><td><div> <input type="checkbox"/> </div></td></tr></table> | Prescription Use (Part 21 CFR 201 Subpart D) | Over-The-Counter Use (21 CFR 201 Subpart G) | <div> <input checked="true" type="checkbox"/> </div> | <div> <input type="checkbox"/> </div> |
|------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|---------------------------------------------|------------------------------------------------------|---------------------------------------|
| Prescription Use (Part 21 CFR 201 Subpart D) | Over-The-Counter Use (21 CFR 201 Subpart G) | | | | |
| <div> <input checked="true" type="checkbox"/> </div> | <div> <input type="checkbox"/> </div> | | | | |

> Prescription Use (Part 21 CFR 801 Subpart D)

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

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## 510(k) Summary

## K230175

| Applicant/ Sponsor: Canon Inc. |
|--------------------------------------|
| 9-1 Imaikami-cho |
| Nakahara-ku, Kanagawa 211-8501 JAPAN |

| Contact Person: | Mr. Akira Hirai<br>General Manager<br>TEL: [phone]<br>FAX: [phone]<br>[e-mail] | |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Date Prepared: | February 10, 2023 | |
| Subject Device | Manufacturer: Canon Inc.<br>Trade Name: DIGITAL RADIOGRAPHY CXDI-CS01<br>Common Name: Solid State X-Ray Imager (Flat Panel/Digital Imager)<br>Classification Name: Stationary X-ray System<br>Product Code: MQB<br>Regulation: 892.1680, Stationary x-ray system<br>Class: II | |
| Predicate Device: | Clearance: K222661 dated September 27, 2022<br>Manufacturer: Canon Inc.<br>Trade Name: DIGITAL RADIOGRAPHY CXDI-CS01<br>Common Name: Solid State X-Ray Imager (Flat Panel/Digital Imager)<br>Classification Name: Stationary X-ray System<br>Product Code: MQB<br>Regulation: 892.1680, Stationary x-ray system<br>Class: II | |
| Device<br>Description: | The DIGITAL RADIOGRAPHY CXDI-CS01 (hereinafter referred to as CXDI-<br>CS01) is a solid-state x-ray imager. The CXDI-CS01 is a series of detectors and, in<br>the predicate device submission (K222661), consists of the CXDI-702C Wireless,<br>CXDI-402C Wireless, CXDI-710C Wireless, CXDI-810C Wireless, CXDI-410C<br>Wireless, DIGITAL RADIOGRAPHY CXDI-Pro (CXDI-703C Wireless and<br>CXDI-403C Wireless), and DIGITAL RADIOGRAPHY CXDI-Elite (CXDI-720C<br>Wireless).<br>The CXDI-CS01 intercepts x-ray photons, and the scintillator emits visible<br>spectrum photons that illuminate an array of photodetectors that create electrical<br>signals. After the electrical signals are generated, the signals are converted to digital<br>values. The digital values are sent to the PC via a wired or wireless connection,<br>converted to images with the CXDI Control Software, and then displayed on the<br>PC/monitors. The PC/monitors used with the CXDI-CS01 are not a part of this<br>submission.<br>The subject of this Special 510(k) submission is the changes to the predicate CXDI-<br>CS01, which include the addition of the DIGITAL RADIOGRAPHY CXDI-Pro<br>detector (CXDI-803C Wireless) and the DIGITAL RADIOGRAPHY CXDI-Elite<br>detectors (CXDI-820C Wireless and CXDI-420C Wireless) to the CXDI-CS01<br>series of detectors, a firmware update of the DIGITAL RADIOGRAPHY CXDI-Pro<br>and DIGITAL RADIOGRAPHY CXDI-Elite detectors from 01.01.03.00 to<br>01.02.00.01 and from F2.00.03.00 to 02.01.04.00 respectively, and a CXDI Control | |

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| 510(k) Summary | K230175 |
|-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Software version update from V3.10.2.2 to V3.10.2.6 to fix bugs. Together, these changes make up the CXDI-CS01. |
| Indications for Use: | The DIGITAL RADIOGRAPHY CXDI-CS01 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 proposed CXDI-CS01 is substantially equivalent to the predicate device. The major differences between the proposed CXDI-CS01 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. |

| | New Device | Predicate Device |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | DIGITAL RADIOGRAPHY CXDI-CS01 | DIGITAL RADIOGRAPHY CXDI-CS01 |
| 510(k)<br>Submitter<br>[Number] | Canon Inc.<br>[K230175] | Canon Inc.<br>[K222661] |
| Indications for<br>Use | The DIGITAL RADIOGRAPHY CXDI-CS01 provides<br>digital image capture for conventional film/screen<br>radiographic examinations. This device is intended to<br>capture, for display, radiographic images of human anatomy,<br>and to replace radiographic film/screen systems in all general<br>purpose diagnostic procedures. This device is not intended<br>for mammography applications. | The DIGITAL RADIOGRAPHY CXDI-CS01 provides<br>digital image capture for conventional film/screen<br>radiographic examinations. This device is intended to<br>capture, for display, radiographic images of human anatomy,<br>and to replace radiographic film/screen systems in all general<br>purpose diagnostic procedures. This device is not intended<br>for mammography applications. |
| Application | General Radiography | General Radiography |
| Software | CXDI Control Software V3.10.2.6 | CXDI Control Software V3.10.2.2 |
| Components | Detectors<br>Battery Pack (LB-4A)<br>Battery Charger (BC-1A/BC-01)<br>Multi Box (MB-4A/MB-02)<br>Power Box (PB-01)<br>Ready Indicator (RI-3A)<br>Status Indicator (SI-4A/SI-01)<br>Wiring Cable (WC-4A/WC-01)<br>PC Connection Cable (CP-4A/CP-01)<br>Docking Station (DS-4A)<br>Detector Stand (DS-01) | Detectors<br>Battery Pack (LB-4A)<br>Battery Charger (BC-1A/BC-01)<br>Multi Box (MB-4A/MB-02)<br>Power Box (PB-01)<br>Ready Indicator (RI-3A)<br>Status Indicator (SI-4A/SI-01)<br>Wiring Cable (WC-4A/WC-01)<br>PC Connection Cable (CP-4A/CP-01)<br>Docking Station (DS-4A)<br>Detector Stand (DS-01) |
| Detector | CXDI-702C Wireless<br>CXDI-402C Wireless<br>CXDI-710C Wireless<br>CXDI-810C Wireless<br>CXDI-410C Wireless<br>CXDI-Pro:<br>CXDI-703C Wireless<br>CXDI-803C Wireless<br>CXDI-403C Wireless<br>CXDI-Elite:<br>CXDI-720C Wireless<br>CXDI-420C Wireless<br>CXDI-820C Wireless | CXDI-702C Wireless<br>CXDI-402C Wireless<br>CXDI-710C Wireless<br>CXDI-810C Wireless<br>CXDI-410C Wireless<br>CXDI-Pro:<br>CXDI-703C Wireless<br>CXDI-803C Wireless<br>CXDI-403C Wireless<br>CXDI-Elite:<br>CXDI-720C Wireless |
| | New Device | Predicate Device |
| Trade Name | DIGITAL RADIOGRAPHY CXDI-CS01 | DIGITAL RADIOGRAPHY CXDI-CS01 |
| Scintillator | CsI(Tl)<br>[Cesium Iodide doped with Thallium] | CsI(Tl)<br>[Cesium Iodide doped with Thallium] |
| | CXDI-702C Wireless, CXDI-402C Wireless, CXDI-710C<br>Wireless, CXDI-810C Wireless, CXDI-410C Wireless, and<br>CXDI-Elite: | CXDI-702C Wireless, CXDI-402C Wireless, CXDI-710C<br>Wireless, CXDI-810C Wireless, CXDI-410C Wireless, and<br>CXDI-Elite: |
| Pixel Pitch | 125μm | 125μm |
| | CXDI-Pro: | CXDI-Pro: |
| | 140 μm | 140 μm |
| | CXDI-702C Wireless, CXDI-402C Wireless, CXDI-710C<br>Wireless, CXDI-810C Wireless, CXDI-410C Wireless, and<br>CXDI-Pro: | CXDI-702C Wireless, CXDI-402C Wireless, CXDI-710C<br>Wireless, CXDI-810C Wireless, CXDI-410C Wireless, and<br>CXDI-Pro: |
| Spatial<br>Resolution | 35% [MTF@2lp/mm] | 35% [MTF@2lp/mm] |
| | CXDI-Elite: | CXDI-Elite: |
| | 45% [MTF@2lp/mm]<br>CXDI-702C Wireless: | 45% [MTF@2lp/mm]<br>CXDI-702C Wireless: |
| | 58% [@0.5 lp/mm, 1 mR] | 58% [@0.5 lp/mm, 1 mR] |
| | CXDI-402C Wireless:<br>58% [@0.5 lp/mm, 3.5 uGy] | CXDI-402C Wireless:<br>58% [@0.5 lp/mm, 3.5 uGy] |
| DQE | CXDI-710C Wireless, CXDI-810C Wireless, and CXDI-<br>410C Wireless:<br>60% [@0 lp/mm, 4 uGy] | CXDI-710C Wireless, CXDI-810C Wireless, and CXDI-<br>410C Wireless:<br>60% [@0 lp/mm, 4 uGy] |
| | CXDI-Pro: | CXDI-Pro: |
| | 58% [@0.5 lp/mm, 3.5 uGy] | 58% [@0.5 lp/mm, 3.5 uGy] |
| | CXDI-Elite: | CXDI-Elite: |
| | 67% [@0.5 lp/mm, 3.5 uGy] | 67% [@0.5 lp/mm, 3.5 uGy] |
| | CXDI-702C Wireless and CXDI-402C Wireless IP54<br>CXDI-710C Wireless, CXDI-810C Wireless, and CXDI-<br>410C Wireless: | CXDI-702C Wireless and CXDI-402C Wireless IP54<br>CXDI-710C Wireless, CXDI-810C Wireless, and CXDI-<br>410C Wireless |
| IP Level | IPX7 | IPX7 |
| | CXDI-Pro: | CXDI-Pro: |
| | IP55 | IP55 |
| | CXDI-Elite: | CXDI-Elite: |
| | IP57 | IP57 |
| | CXDI-702C Wireless, CXDI-402C Wireless, CXDI-710C<br>Wireless, CXDI-810C Wireless, and CXDI-410C Wireless: | CXDI-702C Wireless, CXDI-402C Wireless, CXDI-710C<br>Wireless, CXDI-810C Wireless, and CXDI-410C Wireless: |
| Wireless<br>Communication | IEEE 802.11n<br>2.4GHz/5GHz | IEEE 802.11n<br>2.4GHz/5GHz |
| | CXDI-Pro and CXDI-Elite: | CXDI-Pro and CXDI-Elite: |
| | IEEE 802.11a/b/g/n/ac | IEEE 802.11a/b/g/n/ac |
| | 2.4GHz/5GHz<br>Bluetooth Low Energy | 2.4GHz/5GHz<br>Bluetooth Low Energy |
| | CXDI-702C Wireless, CXDI-402C Wireless, and CXDI-Pro: | CXDI-702C Wireless, CXDI-402C Wireless, and CXDI-Pro: |
| | Standard Synchronization Mode and<br>Non Generator Connection Mode | Standard Synchronization Mode and<br>Non Generator Connection Mode |
| | CXDI-710C Wireless, CXDI-810C Wireless, and CXDI-<br>410C Wireless: | CXDI-710C Wireless, CXDI-810C Wireless, and CXDI-<br>410C Wireless: |
| Photographing<br>Mode | Standard Synchronization Mode,<br>Non Generator Connection Mode, and Standalone Mode | Standard Synchronization Mode,<br>Non Generator Connection Mode, and Standalone Mode |
| | CXDI-Elite: | CXDI-Elite: |
| | Standard Synchronization Mode,<br>Standard Synchronization Mode with Built in AEC<br>Assistance,<br>Non Generator Connection Mode, and<br>Standalone Mode | Standard Synchronization Mode,<br>Standard Synchronization Mode with Built in AEC<br>Assistance,<br>Non Generator Connection Mode, and<br>Standalone Mode |

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## 510(k) Summary

## K230175

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### 510(k) Summary

### K230175

The fundamental scientific technology of the CXDI-CS01 has not been modified. Summary of The major change is the addition of new detectors and component. Non-Clinical/ Test Data: Evaluation of the addition of the new detectors confirmed that the change did not impact the conformance of CXDI-CS01 with the U.S. Performance Standard for radiographic equipment and 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, 60601-2-54, 62220-1, 62304, and 62366. The design control activities and biocompatibility evaluation successfully demonstrated that the modifications to the predicate device raise no new questions regarding either safety or effectiveness. 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-CS01, works as intended. Therefore, the verification/validation activities conducted support a determination of substantial equivalence for the CXDI-CS01. 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. Conclusion: Canon Inc. considers the DIGITAL RADIOGRAPHY CXDI-CS01 device 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.