Enhanced Feature Software Pack CXDI Series

K190368 · Canon, Inc. · MQB · Mar 13, 2019 · Radiology

Device Facts

• Record ID: K190368
• Device Name: Enhanced Feature Software Pack CXDI Series
• Applicant: Canon, Inc.
• Product Code: MQB · Radiology
• Decision Date: Mar 13, 2019
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1680
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

As a part of the CXDI series radiography system, the CXDI Control Software when used with a compatible CXDI detector is intended to provide digital image capture, processing, and display for conventional film/screen radiographic examinations. This device is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures including specialist areas like intensive care, trauma, and pediatric work. This device is not intended for fluoroscopic, angiographic, or mammography applications.

Device Story

The Enhanced Feature Software Pack for CXDI Series is a software update for Canon CXDI radiography systems. It introduces 'One Shot Long Length' imaging, which captures images across multiple compatible flat panel detectors (CXDI-710C Wireless, CXDI-410C Wireless) in a single X-ray exposure. The software automatically stitches these images into a single long-length image (up to 120cm) and provides tools for manual adjustment of stitch positions. The device is used in clinical settings by healthcare professionals to replace traditional film/screen systems. The output is a digital radiographic image displayed for diagnostic review. The software also retains previously cleared scatter correction features. The system benefits patients by enabling long-length imaging with a single exposure, potentially reducing radiation dose and procedure time compared to multi-exposure methods.

Clinical Evidence

Bench testing only. The device modification was evaluated using FMEA methodology to analyze risks and hazardous impacts. Risk control and protective measures were implemented and verified. The system complies with established electrical safety and electromagnetic compatibility standards (IEC 60601-1, 60601-1-2, 60601-1-3, 60601-2-32) and FCC/IC standards for wireless detectors.

Technological Characteristics

Software-based image processing for digital radiography. Features automatic and manual image stitching for long-length imaging (up to 120cm). Compatible with Canon CXDI-710C and CXDI-410C Wireless detectors. Complies with IEC 60601-1, 60601-1-2, 60601-1-3, 60601-2-32, 47CFR 2.1093, FCC Part 15 Subpart B, and ICES-003.

Indications for Use

Indicated for digital radiographic image capture, processing, and display in general purpose diagnostic procedures, including intensive care, trauma, and pediatric applications. Not indicated for fluoroscopic, angiographic, or mammography use.

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

• Scatter Correction for CXDI Series (K153312)
• Canon DIGITAL RADIOGRAPHY CXDI Series Detectors (K170332)
• Canon DIGITAL RADIOGRAPHY CXDI Series Detectors (K171270)

Submission Summary (Full Text)

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Image /page/0/Picture/0 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 features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Canon, Inc. % Ms. Katie Reneson Regulatory Specialist Ken Block Consulting 800 East Campbell Road. Suite 202 RICHARDSON TX 75081

March 13, 2019

Re: K190368

Trade/Device Name: Enhanced Feature Software Pack for CXDI Series Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB Dated: February 14, 2019 Received: February 15, 2019

Dear Ms. Reneson:

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

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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

(http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Michael D. O'Hara

For

Thalia Mills, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

K190368

#### Device Name

Enhanced Feature Software Pack for CXDI Series

Indications for Use (Describe)

As a part of the CXDI series radiography system, the CXDI Control Software when used with a compatible CXDI detector is intended to provide digital image capture, and display for conventional film/screen radiographic examinations. This device is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures including specialist areas like intensive care, trauma, and pediatric work. This device is not intended for fluoroscopic, angiographic, or mammography applications.

| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------|
| <div> <span> <span style="text-decoration: underline;"></span>Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <span>Over-The-Counter Use (21 CFR 801 Subpart C)</span> |

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### 5. Special 510(k) SUMMARY

| Submitter: | Canon, Inc.<br>30-2 Shimomaruko, 3-chrome<br>Ohta-ku, Tokyo 146-8501 Japan |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mr. Tatsuya Yamazaki<br>General Manager<br>TEL: [phone];<br>FAX: [phone]<br>[e-mail] |
| Date Prepared: | February 14, 2019 |
| Submission Type: | Special 510(k) Submission |
| Trade Name: | Enhanced Feature Software Pack for CXDI Series |
| Common Name: | Solid State X-Ray Imager (Flat Panel/Digital Imager) |
| Regulatory Number: | 21 CFR 892.1680 |
| Classification Name: | Stationary X-ray system |
| Product Code: | MQB |
| Primary Predicate #1: | MQB K153312 Scatter Correction for CXDI Series |
| Predicate #2: | MQB Canon DIGITAL RADIOGRAPHY CXDI Series Detectors<br>510(k) # Models<br>K170332 CXDI-710C Wireless<br>K171270 CXDI-410C Wireless |

The subject of this Special 510(k) submission is a change to the CXDI Control Device Description: Software to incorporate the ability to capture an automatically stitched long length image in a single exposure. The addition of the One Shot Long Length to the cleared Scatter Correction of CXDI Series is the subject of this Special 510(k) Submission. The One Shot Long Length stitches long length images into a single image which is accomplished by using multiple detectors, a single exposure, and the automatic stitching software. The One Shot Long Length software feature along with the Scatter Correction cleared under K153312 make up the Enhanced Feature Software Pack for CXDI Series. The Scatter Correction clearance and compatible detectors are not impacted by this submission. This submission adds the One Shot Long Length feature to limited compatible FPDs. The One Shot Long Length feature included in the Enhanced Feature Software Pack for CXDI Series also includes features for manual stitching to allow for users to manually adjust and fine-tune the stitch positions after the automatic stitch operation. By incorporating the One Shot Long Length imaging into the CXDI Control Software, images up to 120cm in length can be acquired in one exposure. The firmware within the flat panel detectors did not require updating. The flat panel detectors that have been previously cleared by FDA and are compatible with the Enhanced Feature Software Pack for CXDI Series have not been physically modified and performance have not changed.

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#### Indications for Use Statement

The intended use of the modified device, as described in the labeling, has not changed as a result of the modification(s).

As a part of the CXDI series radiography system, the CXDI Control Software when used with a compatible CXDI detector is intended to provide digital image capture, processing, and display for conventional film/screen radiographic examinations. This device is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures including specialist areas like intensive care, trauma, and pediatric work. This device is not intended for fluoroscopic, angiographic, or mammography applications.

## Summary of Technological Characteristics:

Comparisons with the predicate devices show the characteristics of the proposed addition of the One Shot Long Length feature to the Enhanced Feature Software Pack for CXDI Series to be substantially equivalent to the predicate device(s). The One Shot Long Length feature of the Enhanced Feature Software Pack for CXDI Series can only be used with compatible Canon CXDI detectors CXDI-710C Wireless, CXDI-410C Wireless.

| Trade Name | Proposed Device<br>Enhanced Feature Software Pack<br>for CXDI Series | Predicate<br>Control Software V2.14<br>Scatter Correction | |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| 510(k)<br>Submitter<br>[Number] | Canon, Inc.<br>[K190368] | Canon, Inc.<br>[K153312] | IDENTICAL |
| Indication<br>for Use | As a part of the CXDI series<br>radiography system, the CXDI<br>Control Software when used<br>with a compatible CXDI<br>detector is intended to provide<br>digital image capture,<br>processing, and display for<br>conventional film/screen<br>radiographic examinations. This<br>device is intended to replace<br>radiographic film/screen systems<br>in all general purpose diagnostic<br>procedures including specialist<br>areas like intensive care, trauma,<br>and pediatric work. This device<br>is not intended for fluoroscopic.<br>angiographic, or mammography<br>applications. | As a part of the CXDI series<br>radiography system, the CXDI<br>Control Software when used<br>with a compatible CXDI<br>detector is intended to provide<br>digital image capture,<br>processing, and display for<br>conventional film/screen<br>radiographic examinations.<br>This device is intended to<br>replace radiographic<br>film/screen systems in all<br>general purpose diagnostic<br>procedures including specialist<br>areas like intensive care,<br>trauma, and pediatric work.<br>This device is not intended for<br>fluoroscopic, angiographic, or<br>mammography applications. | IDENTICAL |
| Scatter<br>Correction | An image can be created (with<br>high contrasts) by using software<br>algorithm, in clinical field,<br>without a grid | An image can be created (with<br>high contrasts) by using<br>software algorithm, in clinical<br>field, without a grid | IDENTICAL |
| One Shot<br>Long Length<br>Imaging | One exposure to obtain images<br>across multiple detectors,<br>automatically stitched together<br>with ability to make manual<br>adjustments after the automatic<br>stitching. | N/A | MODIFIED |
| Software<br>/Version | CXDI Control Software V2.17 | CXDI Control Software V2.14<br>(highest version cleared<br>previously) | MODIFIED |

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| Trade Name | Proposed Device<br>Canon DIGITAL<br>RADIOGRAPHY CXDI Series<br>Detectors containing Enhanced<br>Feature Software Pack for CXDI<br>Series | Predicate Device<br>Canon DIGITAL<br>RADIOGRAPHY CXDI<br>Series Detectors | |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| 510(k)<br>Submitter<br>[Number] | Canon, Inc.<br>[K190368] | Canon, Inc.<br>[K170332, K171270] | IDENTICAL |
| Indication<br>for Use | The DIGITAL<br>RADIOGRAPHY CXDI Series<br>Detectors provides digital image<br>capture for conventional<br>film/screen radiographic<br>examinations. This device is<br>intended to capture for display<br>radiographic images of human<br>anatomy, and to replace<br>radiographic film/screen systems<br>in all general purpose diagnostic<br>procedures. This device is not<br>intended for mammography<br>applications. | The DIGITAL<br>RADIOGRAPHY CXDI<br>Series Detectors provides<br>digital image capture for<br>conventional film/screen<br>radiographic examinations.<br>This device is intended to<br>capture for display<br>radiographic images of human<br>anatomy, and to replace<br>radiographic film/screen<br>systems in all general purpose<br>diagnostic procedures. This<br>device is not intended for<br>mammography applications. | IDENTICAL |
| Scatter<br>Correction | An image can be created (with<br>high contrasts) by using software<br>algorithm, in clinical field,<br>without a grid | An image can be created (with<br>high contrasts) by using<br>software algorithm, in clinical<br>field, without a grid | IDENTICAL |
| One Shot<br>Long Length<br>Imaging | One exposure to obtain images<br>across multiple detectors,<br>automatically stitched together<br>with ability to make manual<br>adjustments after the automatic<br>stitching. | N/A | MODIFIED |
| Firmware<br>/Version | 04-02-0c-00 | 04-02-0b-00 | MODIFIED |

Performance: The hardware within the Canon Digital Radiography CXDI Series Detectors has not been modified, the detectors have the same performance, biocompatibility, effectiveness, and safety and is substantially equivalent to the predicate device. The risks and hazardous impacts of the device modification were analyzed by FMEA methodology. The specific risk control and protective measures to mitigate the risks from the modification were reviewed and implemented as part of product design. The overall assessment concluded that all identified risks and hazardous conditions were successfully mitigated and accepted. As reported in prior submissions to FDA, the compatible detectors comply 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, and 60601-2-32. The wireless detectors also comply with the FCC test standard for SAR, specifically 47CFR 2.1093 and for EMI test regulations FCC Part 15 Subpart B:2012 Class A and ICES-003 Issue 5:2012 Class A. Canon, Inc. considers the Enhanced Feature Software Pack for CXDI Series 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.