The DIGITAL RADIOGRAPHY CXDI-710C Wireless and CXDI-810C 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.

Device Description

The two models of detectors included in this submission are solid state x-ray imagers. Model CXDI-710C Wireless has an approximate imaging area of 35.0 x 42.6 cm, while model CXDI-810C Wireless has an approximate imaging area of 35.0 x 27.4 cm. For both models, the detector intercepts x-ray photons and the scintillator emits visible spectrum photons that illuminate an array of photo-detectors 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 wiring connection or wireless. For the proposed models, temporary image storage is now possible and the detector weight has been reduced from that of the predicates. The proposed models have increased protection against ingress, continue to include the Non-Generator Connection Mode (detection of x-ray irradiation without direct electrical connection to the x-ray generator) and are compatible with the Scatter Correction feature.

AI/ML Overview

This document is a 510(k) summary for the Canon Digital Radiography CXDI-710C Wireless and CXDI-810C Wireless devices. It describes their equivalence to predicate devices rather than proving a new or unique performance based on specific clinical acceptance criteria in the way a novel AI algorithm might. Therefore, the information typically found for AI/ML device approval concerning acceptance criteria, ground truth establishment, and clinical study details (like MRMC studies) is not present.

However, based on the provided text, we can infer some aspects and extract relevant information about the non-clinical testing performed to demonstrate substantial equivalence.

Here's an analysis based on the provided document:

1. A table of acceptance criteria and the reported device performance:

Since this is a 510(k) for a digital radiography detector aiming for substantial equivalence to a predicate device, the "acceptance criteria" are primarily related to meeting performance specifications comparable to the predicate and complying with relevant standards, rather than clinical efficacy metrics for a new diagnostic claim.

Acceptance Criteria (Implied)	Reported Device Performance
Functional Equivalence to Predicate	"The proposed devices are functionally identical to the predicate devices." (Page 4) "The evaluations of the CXDI-710C / 810C Wireless compared to the CXDI-701C / 801C Wireless, show the CXDI-710C / 810C Wireless to be equivalent to the CXDI-701C / 801C Wireless." (Page 5) "Canon, Inc. – Medical Equipment Group considers the DIGITAL RADIOGRAPHY CXDI-710C Wireless and DIGITAL RADIOGRAPHY CXDI-810C Wireless devices to be 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." (Page 5)
Safety and Effectiveness Demonstration	"Tests were performed on the models which demonstrated that the device is safe and effective..." (Page 5) "...raises no new questions regarding either safety or effectiveness when compared to the predicate device(s)." (Page 5)
Image Quality (Implied comparability to predicate)	"non-clinical image comparisons involving flat panel display images taken with the new device and the predicate device(s)." (Page 5)
Compliance with FDA Guidance for Software in Medical Devices	"Documentation was provided demonstrating compliance... to all FDA requirements stated in Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices for a moderate LOC, including results of verification/validation plus traceability of verification/validation tests to software requirements and software risk hazards." (Page 5)
Compliance with FDA Guidance for Solid State X-ray Devices	"Documentation was provided demonstrating that the CXDI-710C / 810C Wireless complies with the FDA requirements stated in Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices." (Page 5)
Compliance with Radiographic Equipment Standards	"Testing confirmed that the CXDI-710C Wireless and CXDI-810C Wireless complies with the U.S. Performance Standard for radiographic equipment and with relevant voluntary safety standards for Electrical safety and Electromagnetic Compatibility testing, specifically IEC standards 60601-1, 60601-1-6, and 60601-2-54." (Page 5)
Physical Characteristics (Comparable or Improved)	Weight: New: 710C: 2.3 kg, 810C: 1.8 kg vs. Predicate: 701C: 3.3 kg, 801C: 2.3 kg (Improved/Reduced Weight) (Page 4) External Dimensions, Scintillator, Pixel Pitch, Pixels, Spatial Resolution: (Functionally Equivalent/The Same) (Page 4)

2. Sample sized used for the test set and the data provenance:

Sample Size for Test Set: The document does not specify a "test set" in terms of patient images for clinical evaluation in the way an AI algorithm study would. The testing appears to be primarily non-clinical, involving functional specifications, image comparisons (presumably phantom or test patterns given the context of a DR detector), and compliance testing. No specific number of images or cases for clinical validation is mentioned.
Data Provenance: Not applicable as no specific clinical patient data set or clinical study is described. The tests are non-clinical (e.g., "non-clinical image comparisons," "verification/validation testing to internal functional specifications").

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. As this is a 510(k) for a digital radiography panel showing substantial equivalence to a predicate, and not a novel diagnostic AI algorithm, there is no mention of human expert readers establishing ground truth on a clinical test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. No clinical test set with human readers requiring adjudication is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No MRMC study was done. This 510(k) is for a digital X-ray detector, not an AI-assisted diagnostic software.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

The device itself is a standalone imaging device (digital radiography detector). Its performance is evaluated intrinsically through physical and image quality metrics and comparison to a predicate, not as an algorithm performing a diagnostic task. The "Standalone function" mentioned under "Control SW" and "Device FW" (Page 4) refers to the detector's ability to save captured images internally without immediate connection to an external device, which is a technical feature, not a diagnostic performance claim.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Not applicable in the context of diagnostic ground truth from patient data. The "ground truth" for this device's evaluation is primarily its adherence to engineering specifications, image quality standards (e.g., MTF), and compliance with regulatory standards, as demonstrated through non-clinical testing. Comparison is made against a predicate device.

8. The sample size for the training set:

Not applicable. This is not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established:

Not applicable. This is not an AI/ML algorithm that requires a training set or ground truth establishment for training.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines suggesting movement or connection.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 1, 2017

Canon, Inc. % Ms. Diane Rutherford Submissions Manager Ken Block Consulting 1201 Richardson Drive, Suite 160 RICHARDSON TX 75080

Re: K170332

Trade/Device Name: Digital Radiography CXDI-710C Wireless Digital Radiography CXDI-810C Wireless Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MOB Dated: January 6, 2017 Received: February 2, 2017

Dear Ms. Rutherford:

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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Michael D'Hara

For

Robert Ochs, 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: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K170332

Device Name DIGITAL RADIOGRAPHY CXDI-710C Wireless DIGITAL RADIOGRAPHY CXDI-810C Wireless

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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."

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5. 510(k) SUMMARY

Submitter:	Canon, Inc. - Medical Equipment Group9-1, Imaikami-cho, Nakahara-kuKawasaki, Kanagawa 211-8501 Japan
Contact Person:	Mr. Shinji MoriManagerTEL: 81-3-3758-2111FAX: 81-44-739-6493mori.shinji@canon.co.jp
Date Prepared:	January 26, 2017
Proposed Device	Manufacturer:Trade Name:Common Name:Classification Name:Product Code /Regulatory Standard:	CanonDIGITAL RADIOGRAPHY CXDI-710C WirelessDIGITAL RADIOGRAPHY CXDI-810C WirelessSolid State X-ray ImagerStationary X-ray systemMQB892.1680 Stationary X-ray System
Predicate Device:	Clearance:Manufacturer:Trade Name:Common Name:Classification Name:Product Code /Regulatory Standard:	K131106 dated July 03, 2013CanonDIGITAL RADIOGRAPHY CXDI-701C WirelessDIGITAL RADIOGRAPHY CXDI-801C WirelessSolid State X-ray ImagerStationary X-ray systemMQB892.1680 Stationary X-ray System
Device Description:	The two models of detectors included in this submission are solid state x-ray imagers.Model CXDI-710C Wireless has an approximate imaging area of 35.0 x 42.6 cm,while model CXDI-810C Wireless has an approximate imaging area of 35.0 x 27.4 cm.For both models, the detector intercepts x-ray photons and the scintillator emitsvisible spectrum photons that illuminate an array of photo-detectors that createelectrical signals. After the electrical signals are generated, the signals are convertedto digital values and the images will be displayed on monitors. The digital value canbe communicated to the operator console via wiring connection or wireless.For the proposed models, temporary image storage is now possible and the detectorweight has been reduced from that of the predicates. The proposed models haveincreased protection against ingress, continue to include the Non-GeneratorConnection Mode (detection of x-ray irradiation without direct electrical connectionto the x-ray generator) and are compatible with the Scatter Correction feature.
Indications for Use:	The DIGITAL RADIOGRAPHY CXDI-710C Wireless and CXDI-810C Wirelessprovide digital image capture for conventional film/screen radiographicexaminations. These devices are intended to capture, for display, radiographic imagesof human anatomy, and to replace radiographic film/screen systems in all generalpurpose diagnostic procedures. These devices are not intended for mammographyapplications.

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5. 510(k) SUMMARY (continued)

Summary of Technological Characteristics: Comparisons with the predicate devices show the technological characteristics of the proposed DIGITAL RADIOGRAPHY CXDI-710C Wireless and DIGITAL RADIOGRAPHY CXDI-810C Wireless devices to be substantially equivalent to the predicate devices. The proposed devices are functionally identical to the predicate devices.

The major difference between the proposed and predicate devices is that the proposed devices have a reduction in weight and can save captured in an internal nonvolatile memory of the detector. No other technological changes have been made to the proposed devices.

	New Devices: K170332CXDI-710C / 810C Wireless	Predicate Device: K131106CXDI-701C / 801C Wireless
Indication for Use	The DIGITAL RADIOGRAPHY CXDI-710CWireless and CXDI-810C Wireless providesdigital image capture for conventionalfilm/screen radiographic examinations.This device is intended to capture, fordisplay, radiographic images of humananatomy, and to replace radiographicfilm/screen systems in all general purposediagnostic procedures. This device is notintended for mammography applications.	The DIGITAL RADIOGRAPHY CXDI-701GWireless, CXDI-701C Wireless, CXDI-801GWireless and CXDI-801C Wireless providedigital image capture for conventionalfilm/screen radiographic examinations.These devices are intended to replaceradiographic film/screen systems in allgeneral purpose diagnostic procedures.These devices are not intended formammography applications.
Application	General Radiography	General Radiography
Scintillator	CsI(TI)[Cesium lodide doped with Thallium]	CsI(TI)[Cesium lodide doped with Thallium]
Pixel Pitch	125 µm	125µm
Pixels	710C: 2,800 x 3,408 (~ 9.5 mil)810C: 2,800 x 2,192 (~ 6.1 mil)	701C: 2,800 x 3,408 (~ 9.5 mil)801C: 2,192 x 2,800 (~ 6.1 mil)
ExternalDimensions	710C: 384 x 460 x 15.7 mm810C: 307.5 x 384 x 15.7 mm	701C: 384 x 460 x 15 mm801C: 307 x 384 x 15 mm
Weight	710C: 2.3 kg810C: 1.8 kg	701C: 3.3 kg801C: 2.3 kg
Spatial Resolution	35% [MTF@2lp/mm]	35% [MTF@2lp/mm]
Control SW	CXDI Control SoftwareAdded Standalone function	CXDI Control Software
Device FW	PCA-FE-710Added Standalone functionAdded wireless channels with DFS andTPC functions	PCA-FE-701
Wireless Functions	Communication between Detector and:Multi BoxControl PC	Communication between Detector and:X-ray I/F UnitControl PC

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. Before using the product, be sure to read the manual thoroughly in order to utilize it more effectively.

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Summary of Non-Clinical / Test Data:

Tests were performed on the models which demonstrated that the device is safe and effective, performs comparably to the predicate device(s), and is substantially equivalent to the predicate device(s). Tests included verification/validation testing to internal functional specifications (including software) and non-clinical image comparisons involving flat panel display images taken with the new device and the predicate device(s). Documentation was provided demonstrating compliance of the CXDI-710C Wireless and CXDI-810C Wireless to all FDA requirements stated in Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices for a moderate LOC, including results of verification/validation plus traceability of verification/validation tests to software requirements and software risk hazards. Other FDA guidance documents used in development include Radio Frequency Wireless Technology in Medical Devices and Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.

Documentation was provided demonstrating that the CXDI-710C / 810C Wireless complies with the FDA requirements stated in Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices. The evaluations of the CXDI-710C / 810C Wireless compared to the CXDI-701C / 801C Wireless, show the CXDI-710C / 810C Wireless to be equivalent to the CXDI-701C / 801C Wireless.

Testing confirmed that the CXDI-710C Wireless and CXDI-810C Wireless complies with the U.S. Performance Standard for radiographic equipment and with relevant voluntary safety standards for Electrical safety and Electromagnetic Compatibility testing, specifically IEC standards 60601-1. 60601-1-6, and 60601-2-54.

Together, these verification/validation activities successfully demonstrated that the CXDI-710C Wireless and CXDI-810C Wireless correctly performs as designed, has been validated for its intended use, and raises no new questions regarding either safety or effectiveness when compared to the predicate device(s). Therefore, the verification/validation_testing_conducted_supports_a_determination_of_substantial equivalence for the CXDI-710C Wireless and CXDI-810C Wireless device.

Conclusion: Canon, Inc. – Medical Equipment Group considers the DIGITAL RADIOGRAPHY CXDI-710C Wireless and DIGITAL RADIOGRAPHY CXDI-810C Wireless devices to be 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.

Regulation Number and Section

§ 892.1680 Stationary x-ray system.

(a)
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.(b)
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.