The DIGITAL RADIOGRAPHY CXDI-410C 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 CXDI-410C Wireless is a solid state x-ray imager with an approximate imaging area of 42.6 x 41.5 cm. 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 model, temporary image storage is now possible and the detector weigh has been reduced from that of the predicate. The proposed model has increased protection against ingress, and continues to include the Standard Synchronization Mode, Non-Generator Connection Mode (detection of x-ray irradiation without direct electrical connection to the x-ray generator), and is compatible with the Scatter Correction feature. Testing has been conducted and has demonstrated that these changes have no impact on the safety or effectiveness of this flat panel detector.

The Standalone Mode allows for examinations using only the detector and a mobile X-ray system without a control computer by utilizing the temporary image storage on the FPD. The CXDI-410C Wireless can be used in emergency/trauma situations and other environments where equipment other than the detector and mobile X-ray system cannot be used and/or wireless communication is not possible.

The weight of the CXDI-410C (2.8kg) is effectively 25% less than the weight of the predicate CXDI-401C (3.8kg.) The weight reduction was accomplished through material changes, changes in the structure, and downsized components such as electrical boards and batteries.

The proposed device CXDI-410C offers an optional docking station. This option allows for a simplified method for charging the internal battery of the proposed CXDI-410C. The Docking Station connects to the PC with an Ethernet cable (cannot communicate wirelessly.) By placing a FPD into the docking station, that FPD is "registered" and available for use.

AI/ML Overview

The provided text describes a 510(k) summary for the DIGITAL RADIOGRAPHY CXDI-410C Wireless device. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a standalone study proving performance against those criteria.

Therefore, many of the requested details about acceptance criteria, specific studies, ground truth establishment, expert involvement, and statistical analyses (like MRMC studies) are not available in the provided text. The document primarily relies on non-clinical image comparisons and compliance with relevant standards to assert substantial equivalence.

Here's the information that can be extracted or inferred from the text, along with details explicitly stated as not available:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics like sensitivity/specificity/accuracy goals. Instead, it focuses on demonstrating equivalency in key technical specifications and performance to a predicate device.

Characteristic	Acceptance Criteria (Inferred from Predicate Equivalence)	Reported Device Performance (CXDI-410C Wireless)
Indication for Use	Equivalent to predicate (digital image capture for conventional film/screen radiographic examinations, general diagnostic procedures, not mammography).	Matches predicate. Digital image capture for conventional film/screen radiographic examinations, general diagnostic procedures, not mammography.
Application	General Radiography	General Radiography
Scintillator	CsI(TI)	CsI(TI)
Pixel Pitch	125 μm	125 μm
Pixels	3,408 x 3,320 (≈ 11.3 mil)	3,408 x 3,320 (≈ 11.3 mil)
DQE	0.6	0.6
Spatial Resolution	35% [MTF@2lp/mm]	35% [MTF@2lp/mm]
Software Functionality	CXDI Control Software features	CXDI Control Software + Added Standalone function
Firmware Functionality	PCA-FE-701 features	PCA-FE-710 + Added Standalone function, wireless channels with DFS and TPC functions
Safety/Effectiveness	Demonstrated to be safe and effective, performing comparably to the predicate device.	Verification/validation testing (including software) and non-clinical image comparisons confirmed safety/effectiveness. Compliance with IEC standards 60601-1, 60601-1-2, 60601-1-6, 60601-2-54.

Key Differences/Improvements:

Weight: Predicate: ≈ 3.8 kg; Proposed: ≈ 2.8 kg (25% reduction)
External Dimensions: Predicate: 460 x 460 x 15.4 mm; Proposed: 460 x 460 x 15.7 mm
Temporary Image Storage: Proposed device adds temporary image storage.
Docking Station: Proposed device offers an optional docking station for charging and registration.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not specified. The document mentions "non-clinical image comparisons involving flat panel display static and dynamic images." The exact number of images or cases used for these comparisons is not provided.
Data Provenance: Not specified (e.g., country of origin, specific institutions). The nature of the "non-clinical images" suggests they were likely test images generated under controlled conditions rather than patient data from a specific country.
Retrospective or Prospective: Not specified, but "non-clinical image comparisons" typically refer to controlled test images rather than retrospective or prospective patient studies.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Number of Experts: Not specified.
Qualifications of Experts: Not specified.

The study referenced is "non-clinical image comparisons." This often implies technical evaluations rather than diagnostic interpretation requiring clinical experts to establish ground truth.

4. Adjudication Method for the Test Set

Adjudication Method: Not specified. Given the nature of "non-clinical image comparisons" for technical equivalence, a formal clinical adjudication process as seen in diagnostic performance studies is unlikely to have been performed or necessary based on this summary.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

MRMC Study: No, an MRMC comparative effectiveness study was not performed or described.
AI Improvement Effect Size: Not applicable, as this device is a digital radiography system (hardware), not an AI-powered diagnostic algorithm enhancing human reader performance. The document describes a flat panel detector, not software with AI capabilities for diagnostic assistance.

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

Standalone Performance: The document refers to "Standalone function" for the device, which means the detector can operate and temporarily store images without a control computer. This is a functional feature of the device's hardware and firmware, not a measure of its diagnostic performance as a standalone algorithm (e.g., classifying disease) in the context of an AI device. The document does not describe a standalone diagnostic algorithm performance study.

7. The Type of Ground Truth Used

Type of Ground Truth: Not explicitly stated but inferred to be technical benchmarks or quantitative image quality metrics for "non-clinical image comparisons." For instance, DQE and MTF values are listed, which are objective measures. There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for these non-clinical comparisons, as these are typically for clinical diagnostic performance studies.

8. The Sample Size for the Training Set

Sample Size: Not applicable and not specified. This device is a digital X-ray detector, not a machine learning or AI algorithm that requires a training set of data.

9. How the Ground Truth for the Training Set was Established

Ground Truth for Training Set: Not applicable. As mentioned, this is a hardware device, not an AI algorithm requiring a training set with established ground truth.

Summary

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November 17, 2017

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 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. - Medical Equipment Group % Ms. Diane Rutherford Submissions Manager Ken Block Consulting 1201 Richardson Drive, Suite 160 RICHARDSON TX 75080

Re: K171270

Trade/Device Name: DIGITAL RADIOGRAPHY CXDI-410C Wireless Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: October 26, 2017 Received: October 27, 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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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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.

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Robert Ocks

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

510(k) Number (if known)

K171270

Device Name DIGITAL RADIOGRAPHY CXDI-410C 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)

Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement below.

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)

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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:	Canon, Inc. - Medical Equipment GroupMr. Shinji MoriManager9-1, Imaikami-cho, Nakahara-kuKawasaki, Kanagawa 211-8501, JapanTEL: 81-3-3758-2111FAX: 81-44-739-6493mori.shinji@canon.co.jp
Date Prepared:	April 26, 2017
Proposed Device	Manufacturer: Canon, Inc. - Medical Equipment GroupTrade Name: DIGITAL RADIOGRAPHY CXDI-410C WirelessCommon Name: Solid State X-Ray Imager (Flat Panel/Digital Imager)Classification Name: Stationary X-ray systemProduct Code / MQBRegulatory Standard: 892.1680, Stationary X-ray System
Predicate Device:	Clearance: K133693 dated July 01, 2014Manufacturer: Canon, Inc. - Medical Equipment GroupTrade Name: DIGITAL RADIOGRAPHY CXDI-401C WirelessCommon Name: Solid State X-Ray Imager (Flat Panel/Digital Imager)Classification Name: Stationary X-ray systemProduct Code / MQBRegulatory Standard: 892.1680, Stationary X-ray System
DeviceDescription:	The CXDI-410C Wireless is a solid state x-ray imager with an approximate imagingarea of 42.6 x 41.5 cm. The detector intercepts x-ray photons and the scintillator emitsvisible spectrum photons that illuminate an array of photo-detectors that create electricalsignals. After the electrical signals are generated, the signals are converted to digitalvalues and the images will be displayed on monitors. The digital value can becommunicated to the operator console via wiring connection or wireless.For the proposed model, temporary image storage is now possible and the detectorweigh has been reduced from that of the predicate. The proposed model has increasedprotection against ingress, and continues to include the Standard Synchronization Mode,Non-Generator Connection Mode (detection of x-ray irradiation without direct electricalconnection to the x-ray generator), and is compatible with the Scatter Correction feature.Testing has been conducted and has demonstrated that these changes have no impact onthe safety or effectiveness of this flat panel detector.The Standalone Mode allows for examinations using only the detector and a mobile X-ray system without a control computer by utilizing the temporary image storage on theFPD. The CXDI-410C Wireless can be used in emergency/trauma situations and otherenvironments where equipment other than the detector and mobile X-ray system cannotbe used and/or wireless communication is not possible.

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The DIGITAL RADIOGRAPHY CXDI-410C Wireless provides digital image capture Statement of Intended Use: 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 Comparisons with the predicate device show the technological characteristics of the Technological proposed DIGITAL RADIOGRAPHY CXDI-410C Wireless device to be substantially Characteristics: equivalent to the predicate device. The proposed device is functionally identical to the predicate device.

The major difference between the proposed and predicate devices is that the proposed device has 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 device.

	New Device: K17CXDI-410C Wireless	Predicate Device: K133693CXDI-401C Wireless
Indication for Use	The DIGITAL RADIOGRAPHY CXDI-410CWireless provides digital image capturefor conventional film/screen radiographicexaminations. This device is intended tocapture, for display, radiographic imagesof human anatomy, and to replaceradiographic film/screen systems in allgeneral purpose diagnostic procedures.This device is not intended formammography applications.	The DIGITAL RADIOGRAPHY CXDI-401CWireless provides digital image capturefor conventional film/screen radiographicexaminations. This device is intended toreplace radiographic film/screen systemsin all general purpose diagnosticprocedures. This device is not intendedfor mammography 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	3,408 x 3,320 (≈ 11.3 mil)	3,408 x 3,320 (≈ 11.3 mil)
ExternalDimensions	460 x 460 x 15.7 mm	460 x 460 x 15.4 mm
Weight	≈ 2.8 kg	≈ 3.8 kg
DQE	0.6	0.6
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

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	Communication between Detector and:	Communication between Detector and:
Wireless Functions	Multi Box	X-ray I/F Unit
	Control PC	Control 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.

Tests were performed on the device which demonstrated that the device is safe and Summary of Non-Clinical / effective, performs comparably to the predicate device, and is substantially equivalent to Test Data: the predicate device. Tests included verification/validation testing to internal functional specifications (including software) and non-clinical image comparisons involving flat panel display static and dynamic images taken with the new device and the predicate device. Documentation was provided demonstrating compliance of the CXDI-410C Wireless to all FDA requirements stated in Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, 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-410C 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-410C Wireless, compared to the predicate, show the CXDI-410C Wireless to be equivalent to the predicate.

Testing confirmed that the CXDI-410C 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, 60601-1-2, 60601-1-6, and 60601-2-54.

Together, these verification/validation activities successfully demonstrated that the CXDI-410C 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. Therefore, the verification/validation testing conducted supports a determination of substantial equivalence for the CXDI-410C Wireless device.

Conclusion: Canon, Inc. – Medical Equipment Group considers the DIGITAL RADIOGRAPHY CXDI-410C Wireless 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.

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.