(45 days)
The DIGITAL RADIOGRAPHY CXDI-702C Wireless and CXDI-402C 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 CXDI-702C Wireless and CXDI-402C Wireless are solid-state x-ray imagers with approximate imaging areas of 350 x 426 mm and 415 x 426 mm, respectively. 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 wired or wireless connection.
The subject of this Special 510(k) submission is a change to the Digital Radiography CXDI-710C Wireless and CXDI-410C Wireless to add the X-ray I/F unit option, update to the CXDI control software, change the IP Level, make changes to the case, and remove Standalone mode. The X-Ray I/F unit synchronizes the timing of the X-ray irradiation with the detector's capture and has been included in other Canon devices (CXDI-701C Wireless (K131106)). The X-Ray I/F Unit is an optional unit that allows the proposed device work together with several older units that use the X-ray I/F Unit instead of the multibox. The IP Level was changed from IPX7 to IP54. The Standalone mode was removed from the proposed devices. The imaging process to sharpen images, Edge Enhancement, was included in the Digital Radiography CXDI-710C Wireless and CXDI-410C Wireless, but adjustments of multiple imaging parameters were required to enhance structured edges. The optional feature, Advanced Edge Enhancement, for CXDI-702C Wireless and CXDI-402C Wireless automatically adjusts the six image processing parameters (Enhancement - Edge Enhancement, Enhancement - Edge Frequency, Enhancement - Contrast Boost, Dynamic Range Adjustment - Dark Region, Dynamic Range Enhancement - Bright Region, and Noise Reduction - Effect) by one button to enhance structures. The CXDI control software has been updated to a new version for functional improvements. The material of the casing of the detector has changed from fiberglass to magnesium alloy. Together, these changes to the Digital Radiography CXDI-710C Wireless and CXDI 410C Wireless make up the Digital Radiography CXDI-702C Wireless and CXDI-402C Wireless.
The provided text describes a 510(k) premarket notification for two digital radiography devices, the CXDI-702C Wireless and CXDI-402C Wireless. This submission is a "Special 510(k)," indicating that the changes made to the devices are minor and fall within established performance specifications, meaning a direct comparative effectiveness study with human readers (MRMC) might not have been the primary focus of the submission for overall device clearance, but rather a demonstration of continued equivalence through specific performance tests and comparative data with predicate devices.
The acceptance criteria and study proving the device meets these criteria can be inferred from the "Summary of Non-Clinical / Test Data" section and the "Comparisons with the predicate devices" table.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission focuses on demonstrating substantial equivalence to predicate devices (CXDI-710C Wireless and CXDI-410C Wireless) after specific modifications. Therefore, the "acceptance criteria" are primarily that the modified devices maintain performance comparable to the predicate devices and meet relevant safety and performance standards. The "reported device performance" is largely framed as successful verification and validation tests and comparability data.
| Acceptance Criteria (Inferred from submission purpose and tests) | Reported Device Performance (Summary) |
|---|---|
| Maintain fundamental scientific technology | The fundamental scientific technology of the DIGITAL RADIOGRAPHY CXDI-702C Wireless and CXDI-402C Wireless has not been modified. |
| Mitigate risks and hazardous impacts of device modifications (e.g., FMEA) | Risks and hazardous impacts of the device modification were analyzed by FMEA methodology. Specific risk control and protective measures were reviewed and implemented. Overall assessment concluded all identified risks and hazardous conditions were successfully mitigated and accepted. |
| Maintain "safe and effective" performance comparable to predicate devices | Tests performed demonstrated that the devices are safe and effective, perform comparably to the predicate devices, and are substantially equivalent to the predicate devices. |
| Meet internal functional specifications (including software) | Verification/validation testing to internal functional specifications (including software) was conducted and results were provided. |
| Produce non-clinical image quality comparable to predicate devices | Non-clinical image comparisons involving flat panel display images taken by the new device and the predicate devices were performed. |
| Usability of new features (e.g., Advanced Edge Enhancement) | Interviews were conducted with experienced clinicians on the usability of the advanced edge enhancement. |
| Compliance with FDA requirements for software (Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices for a moderate LOC) | Documentation was provided demonstrating compliance, including results of verification/validation plus traceability of verification/validation tests to software requirements and software risk hazards. |
| Compliance with other relevant FDA guidance (e.g., Radio Frequency Wireless Technology in Medical Devices, Cybersecurity) | 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 provided confirmed changes do not impact compliance with FDA requirements for Solid State X-ray Imaging Devices. |
| Compliance with U.S. Performance Standard for radiographic equipment and voluntary safety standards (IEC 60601 series) | Testing confirmed that the CXDI-702C Wireless and CXDI-402C Wireless 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, 60601-1-6, and 60601-2-54. |
| Biocompatibility (ISO 10993 series) | Biocompatibility evaluation confirmed that the changes did not impact safety and that the devices comply with ISO 10993-1, 10993-5, and 10993-10. |
| No new questions regarding safety or effectiveness | Verification/validation activities successfully demonstrated that the device continues to meet standards for areas impacted by modifications and raises no new questions regarding either safety or effectiveness when compared to the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state a numerical sample size for the "non-clinical image comparisons" or "interviews with experienced clinicians." It refers to "tests performed on the models" and "non-clinical image comparisons." For a 510(k) Special submission, the focus is often on demonstrating that the modifications do not adversely affect performance, rather than a large-scale clinical trial.
- Data Provenance: Not explicitly stated. Given that it's a submission for products by Canon, Inc. (Japan), the non-clinical tests would typically be performed internally or by contracted labs. The "interviews with experienced clinicians" likely involved healthcare professionals in a relevant market, but the specific country is not detailed. The data is retrospective in the sense that it evaluates the modified device against known performance of the predicate device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not explicitly stated for image evaluation.
- Qualifications of Experts: The document mentions "experienced clinicians" for interviews regarding the usability of the Advanced Edge Enhancement feature. Their specific qualifications (e.g., "radiologist with 10 years of experience") are not detailed. For the image comparisons, it implies internal testing and comparison to established predicate performance rather than requiring independent expert reads to establish ground truth in the same way a diagnostic AI would.
4. Adjudication Method for the Test Set
- Adjudication Method: Not specified. For non-clinical image comparisons demonstrating comparability, a formal adjudication process like 2+1 or 3+1 by multiple readers is not typically detailed in this type of 510(k) submission. It's more about objective image quality metrics and visual comparison against predicate performance.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- MRMC Study: No, the document does not indicate that a formal MRMC comparative effectiveness study was conducted. This type of study is more common for novel diagnostic AI devices where the primary claim is an improvement in human reader performance with AI assistance. For a Special 510(k) of a digital X-ray detector with minor modifications, the focus is on maintaining equivalence rather than demonstrating improvement over human readers.
- Effect Size: Not applicable, as an MRMC study was not described.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable in the context of a digital X-ray detector. The device itself (the detector) processes images and provides them for display, but it doesn't have a diagnostic "algorithm" that operates independently to provide outputs like disease detection that would require a standalone performance evaluation in the same way a diagnostic AI software would. The "Advanced Edge Enhancement" is an image processing feature, not a diagnostic algorithm. The document explicitly states the "Standalone mode was removed from the proposed devices" for how the detector operates, meaning it always communicates with an operator console (human-in-the-loop for image review).
7. The Type of Ground Truth Used
- Ground Truth: For the non-clinical image comparisons, the "ground truth" would be established by comparing the images from the modified device against the known and accepted image quality and characteristics of the legally marketed predicate devices. This isn't "expert consensus" or "pathology" in the diagnostic sense, but rather a technical comparison of image properties (e.g., resolution, contrast, noise, and the visual appearance of anatomical structures) to ensure the modifications did not degrade quality. The "usability" of the Advanced Edge Enhancement was evaluated through clinician interviews, where their feedback implicitly serves as a form of ground truth for user experience.
8. The Sample Size for the Training Set
- Training Set Sample Size: The document does not describe a "training set" because the device is a digital X-ray detector, not an AI algorithm that learns from data. The "Advanced Edge Enhancement" is likely a rule-based or engineered image processing algorithm, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set was Established
- Ground Truth for Training Set: Not applicable, as there is no mention of a training set for an AI algorithm.
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November 7, 2019
Image /page/0/Picture/1 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 includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font size below.
Canon, Inc. % Mr. Gregory Woodard Biomedical Engineer Ken Block Consulting 800 East Campbell Road, Suite 202 RICHARDSON TX 75081
Re: K192632
Trade/Device Name: DIGITAL RADIOGRAPHY CXDI-702C Wireless DIGITAL RADIOGRAPHY CXDI-402C Wireless Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB Dated: November 6, 2019 Received: November 7, 2019
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
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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/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@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For
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
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Indications for Use
510(k) Number (if known) K192632
Device Name DIGITAL RADIOGRAPHY CXDI-702C Wireless DIGITAL RADIOGRAPHY CXDI-402C Wireless
Indications for Use (Describe)
The DIGITAL RADIOGRAPHY CXDI-702C Wireless and CXDI-402C 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.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the word "Canon" in red font. The font is bold and slightly italicized. The word is centered and takes up most of the image.
510(k) SUMMARY
| Submitter: | Canon, Inc.30-2 Shimomaruko, 3-chromeOhta-ku, Tokyo 146-8501 Japan |
|---|---|
| Contact Person: | Mr. Tatsuya YamazakiGeneral ManagerTEL: 81-3-3758-2111;FAX: 81-3-5482-3960yamazaki.tatsuya@mail.canon |
| Date Prepared: | September 20, 2019 |
| Submission Type: | Special 510(k) Submission |
| Proposed Devices: | 510(k) Number: K192632Manufacturer: Canon, Inc.Trade Name: DIGITAL RADIOGRAPHY CXDI-702C WirelessDIGITAL RADIOGRAPHY CXDI-402C 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: | Manufacturer: Canon, Inc.510(k) Number: K170332Trade Name: DIGITAL RADIOGRAPHY CXDI-710C 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) |
| Reference Device: | Manufacturer: Canon, Inc.510(k) Number: K171270Trade 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) |
| Device Description: | The CXDI-702C Wireless and CXDI-402C Wireless are solid-state x-ray imagers with approximate imaging areas of 350 x 426 mm and 415 x 426 mm, respectively. 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 wired or wireless connection.The subject of this Special 510(k) submission is a change to the Digital Radiography CXDI-710C Wireless and CXDI-410C Wireless to add the X-ray I/F unit option, update to the CXDI control software, change the IP Level, make changes to the case, and remove Standalone mode. The X-Ray I/F unit synchronizes the timing of the X-ray irradiation with the detector's capture and has been included in other Canon devices (CXDI-701C Wireless (K131106)). The X-Ray I/F Unit is an optional unit that allows the proposed device work together with several older units that use the X-ray I/F Unit instead of the multibox. The IP Level was changed from IPX7 to IP54. The Standalone mode was removed from the proposed devices. The imaging process to |
| sharpen images, Edge Enhancement, was included in the Digital Radiography CXDI- | |
| 710C Wireless and CXDI-410C Wireless, but adjustments of multiple imaging | |
| parameters were required to enhance structured edges. The optional feature, Advanced | |
| Edge Enhancement, for CXDI-702C Wireless and CXDI-402C Wireless automatically | |
| adjusts the six image processing parameters (Enhancement - Edge Enhancement, | |
| Enhancement - Edge Frequency, Enhancement - Contrast Boost, Dynamic Range | |
| Adjustment - Dark Region, Dynamic Range Enhancement - Bright Region, and Noise | |
| Reduction - Effect) by one button to enhance structures. The CXDI control software | |
| has been updated to a new version for functional improvements. The material of the | |
| casing of the detector has changed from fiberglass to magnesium alloy. Together, these | |
| changes to the Digital Radiography CXDI-710C Wireless and CXDI 410C Wireless | |
| make up the Digital Radiography CXDI-702C Wireless and CXDI-402C Wireless. | |
| The Digital Radiography CXDI-710C Wireless and CXDI-410C Wireless clearances | |
| are not impacted by this submission. | |
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Indication for Use: The Indication for Use statement is identical to the predicate device with the exception of the device name. 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-702C Wireless and CXDI-402C 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.
Comparisons with the predicate devices show the characteristics of the proposed Summary of Technological modifications (addition of the X-Ray I/F unit option, the update to the CXDI control Characteristics: software, change in case material, and the removal of the Standalone mode) to the DIGITAL RADIOGRAPHY CXDI-710C Wireless and CXDI-410C Wireless to be substantially equivalent to the predicate device.
| Trade Name | Proposed Device | Proposed Device | Predicate Device | Reference Device | |
|---|---|---|---|---|---|
| Trade Name | DIGITALRADIOGRAPHYCXDI-702C Wireless | DIGITALRADIOGRAPHYCXDI-402C Wireless | DIGITALRADIOGRAPHYCXDI-710C Wireless | DIGITALRADIOGRAPHYCXDI-410C Wireless | |
| 510(k)Submitter[Number] | Canon, Inc.[K192632] | Canon, Inc.[K170332] | Canon, Inc.[K171270] | IDENTICAL | |
| Indication forUse | The DIGITALRADIOGRAPHYCXDI-702C Wirelessprovides digital imagecapture forconventionalfilm/screenradiographicexaminations. Thisdevice is intended tocapture, for display,radiographic images ofhuman anatomy, and toreplace radiographicfilm/screen systems inall general purposediagnostic procedures.This device is notintended for | The DIGITALRADIOGRAPHYCXDI-402C Wirelessprovides digital imagecapture forconventionalfilm/screenradiographicexaminations. Thisdevice is intended tocapture, for display,radiographic images ofhuman anatomy, and toreplace radiographicfilm/screen systems inall general purposediagnostic procedures.This device is notintended for | The DIGITALRADIOGRAPHYCXDI-710C Wirelessprovides digital imagecapture forconventionalfilm/screenradiographicexaminations. Thisdevice is intended tocapture, for display,radiographic images ofhuman anatomy, and toreplace radiographicfilm/screen systems inall general purposediagnostic procedures.This device is notintended for | The DIGITALRADIOGRAPHYCXDI-410C Wirelessprovides digital imagecapture forconventionalfilm/screenradiographicexaminations. Thisdevice is intended tocapture, for display,radiographic images ofhuman anatomy, and toreplace radiographicfilm/screen systems inall general purposediagnostic procedures.This device is notintended for | IDENTICAL |
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Image /page/5/Picture/0 description: The image contains the word "Canon" in a bold, red font. The letters are large and closely spaced together, creating a strong visual impact. The font appears to be a sans-serif typeface, giving it a modern and clean look. The red color contrasts sharply with the white background, making the word stand out.
| mammographyapplications. | mammographyapplications. | mammographyapplications. | mammographyapplications. | ||
|---|---|---|---|---|---|
| Application | General Radiography | General Radiography | IDENTICAL | ||
| Case Material | Magnesium alloy | Fiberglass | MODIFIED | ||
| Scintillator | CsI(Tl)[Cesium Iodide doped with Thallium] | CsI(Tl)[Cesium Iodide doped with Thallium] | IDENTICAL | ||
| Pixel Pitch | 125µm | 125µm | IDENTICAL | ||
| Pixels | 2,800 x 3,408(≈ 9.5 mil) | 3,408 x 3,320(≈ 11.3 mil) | 2,800 x 3,408(≈ 9.5 mil) | 3,408 x 3,320(≈ 11.3 mil) | IDENTICAL |
| ExternalDimensions | 384 x 460 x 15.7 mm | 460 x 460 x 15.7 mm | 384 x 460 x 15.7 mm | 460 x 460 x 15.7 mm | IDENTICAL |
| Weight | ≈ 3.1 kg | ≈ 3.7 kg | ≈ 2.3 kg | ≈ 2.8 kg | MODIFIED |
| AttenuationEquivalent | Max. 0.40 mmAl | Max. 0.37 mmAl | Max. 0.21 mmAl | MODIFIED | |
| SpatialResolution | 35% [MTF@2lp/mm] | 35% [MTF@2lp/mm] | IDENTICAL | ||
| Control SW | CXDI Control Software V 2.19 | CXDI Control Software V 2.16 | MODIFIED | ||
| WirelessFunctions | Communication between Detector and:Multi BoxControl PCX-ray I/F Unit | Communication between Detector and:Multi BoxControl PC | MODIFIED | ||
| IP Level | IP54 | IPX7 | MODIFIED | ||
| Photographingmode | Standard Synchronization ModeNon Generator Connection Mode | Standard Synchronization ModeNon Generator Connection ModeStandalone Mode | 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. Before using the product, be sure to read the manual thoroughly in order to utilize it more effectively.
Summary of Non-Clinical / Test Data:
The fundamental scientific technology of the DIGITAL RADIOGRAPHY CXDI-702C Wireless and CXDI-402C Wireless has not been modified. 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.
Tests were performed on the models which demonstrated that the devices are safe and effective, perform comparably to the predicate devices, and are substantially equivalent to the predicate devices. Tests included verification/validation testing to internal functional specifications (including software) and non-clinical image comparisons involving flat panel display images taken by the new device and the predicate devices, including the Advanced edge enhancement feature. Interviews were conducted with experienced clinicians on the usability of the advanced edge enhancement.
Documentation was provided demonstrating compliance of the CXDI-702C Wireless and CXDI-402C 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.
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Image /page/6/Picture/0 description: The image shows the word "Canon" in a bold, red font. The letters are slightly stylized, with a slight curve to the top of the "C" and a distinctive shape to the "n". The word is presented against a white background, making the red color stand out.
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 changes to CXDI-710C and CXDI-410C do not impact the device's compliance with FDA requirements stated in Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices.
Testing confirmed that the CXDI-702C Wireless and CXDI-402C Wireless 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, 60601-1-6, and 60601-2-54.
Biocompatibility evaluation confirmed that the changes to CXDI-710C and CXDI-410C do not impact the devices' safety and that the CXDI-702C Wireless and CXDI-402C Wireless comply with ISO 10993-1, 10993-5, and 10993-10.
Together, these verification/validation activities successfully demonstrated that the device continues to meet the standards for the areas impacted by the device 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 testing conducted supports a determination of substantial equivalence for the CXDI-702C Wireless and CXDI-402C Wireless devices.
Conclusion: Canon, Inc. considers the DIGITAL RADIOGRAPHY CXDL-702C Wireless and CXDI-402C Wireless 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.
§ 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.