(26 days)
The DIGITAL RADIOGRAPHY CXDI-CS01 provides digital image capture for conventional film/screen radiographic examinations. This device is intended to capture, for display, radiographic images of human anatomy, and to replace radiographic film/screen systems in all general purpose diagnostic procedures. This device is not intended for mammography applications.
The DIGITAL RADIOGRAPHY CXDI-CS01 (hereinafter referred to as CXDI-CS01) is a solid-state x-ray imager. The CXDI-CS01 is a series of detectors and, in the predicate device submission (K222661), consists of the CXDI-702C Wireless, CXDI-402C Wireless, CXDI-710C Wireless, CXDI-810C Wireless, CXDI-410C Wireless, DIGITAL RADIOGRAPHY CXDI-Pro (CXDI-703C Wireless and CXDI-403C Wireless), and DIGITAL RADIOGRAPHY CXDI-Elite (CXDI-720C Wireless). The CXDI-CS01 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. The digital values are sent to the PC via a wired or wireless connection, converted to images with the CXDI Control Software, and then displayed on the PC/monitors. The PC/monitors used with the CXDI-CS01 are not a part of this submission. The subject of this Special 510(k) submission is the changes to the predicate CXDI-CS01, which include the addition of the DIGITAL RADIOGRAPHY CXDI-Pro detector (CXDI-803C Wireless) and the DIGITAL RADIOGRAPHY CXDI-Elite detectors (CXDI-820C Wireless and CXDI-420C Wireless) to the CXDI-CS01 series of detectors, a firmware update of the DIGITAL RADIOGRAPHY CXDI-Pro and DIGITAL RADIOGRAPHY CXDI-Elite detectors from 01.01.03.00 to 01.02.00.01 and from F2.00.03.00 to 02.01.04.00 respectively, and a CXDI Control Software version update from V3.10.2.2 to V3.10.2.6 to fix bugs. Together, these changes make up the CXDI-CS01.
Here's a breakdown of the acceptance criteria and study information for the DIGITAL RADIOGRAPHY CXDI-CS01, based on the provided FDA 510(k) summary:
This device (DIGITAL RADIOGRAPHY CXDI-CS01) is a digital X-ray imager, and this 510(k) submission (K230175) is a Special 510(k) for changes to a previously cleared predicate device (K222661). The changes primarily involve adding new detectors and a firmware update, along with a minor software bug fix. Therefore, the information related to clinical studies and ground truth establishment will be limited, as determined by the FDA's decision that clinical testing was "not necessary" due to the minor nature of the changes and the device's substantial equivalence to the predicate. Most of the "performance" described here relates to engineering and regulatory compliance rather than clinical diagnostic accuracy.
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a Special 510(k) for minor changes and not a novel device requiring extensive clinical performance validation, the "acceptance criteria" are primarily related to maintaining or demonstrating equivalence in technical specifications and adherence to safety and performance standards. The document primarily focuses on demonstrating that the changes do not negatively impact safety or effectiveness.
| Acceptance Criteria Category | Specific Criteria/Standard | Reported Device Performance | Comments |
|---|---|---|---|
| Technological Equivalence | Similarity in components and software version compared to predicate. | Addition of CXDI-803C Wireless, CXDI-820C Wireless, and CXDI-420C Wireless detectors. Firmware update (01.01.03.00 to 01.02.00.01 for Pro; F2.00.03.00 to 02.01.04.00 for Elite). CXDI Control Software updated from V3.10.2.2 to V3.10.2.6 (bug fix). | The core technology (scintillator, pixel pitch, spatial resolution, DQE, wireless communication, photographing mode) remains identical or equivalent to the predicate for comparable detectors. |
| Safety Standards Adherence | Conformance with U.S. Performance Standard for radiographic equipment and relevant voluntary safety standards. | Confirmed conformance with IEC standards 60601-1, 60601-1-2, 60601-1-3, 60601-1-6, 60601-2-54, 62220-1, 62304, and 62366. | "Evaluation of the addition of the new detectors confirmed that the change did not impact the conformance..." |
| Biocompatibility | Device materials meet biocompatibility requirements. | Biocompatibility evaluation successfully demonstrated no new questions regarding safety or effectiveness. | Assessed based on modifications to the predicate. |
| Intended Use | Maintain the same indications for use as the predicate device. | The proposed indications for use statement is identical to the predicate: "digital image capture for conventional film/screen radiographic examinations... to capture, for display, radiographic images of human anatomy, and to replace radiographic film/screen systems in all general purpose diagnostic procedures. Not intended for mammography applications." | Crucial for establishing substantial equivalence. |
| Performance (Bench Testing) | Device works as intended after modifications. | Adequate detector bench testing conducted to support determination of substantial equivalence. | This is the primary method of validation for this Special 510(k). The document states: "Adequate detector bench testing should be sufficient to demonstrate that the subject detector, CXDI-CS01, works as intended." |
| Guidance Document Compliance | Follow applicable FDA guidance documents. | Followed "Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices," "Guidance for the Content of Premarket Submissions for Software contained in Medical Devices," "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices," "Use of International Standard ISO 10993-1," "Radio Frequency Wireless Technology in Medical Devices," and "Pediatric Information for X-ray Imaging Device Premarket Notifications." | Demonstrates thoroughness in regulatory compliance. |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "Clinical testing is not necessary for the current submission, based on the minor differences from the predicate device." Therefore, there is no explicit clinical "test set" in the traditional sense of human patient data for diagnostic accuracy evaluation.
The "test set" for this submission refers to the detectors and software changes themselves, and the testing performed was primarily "detector bench testing" and evaluations against engineering and regulatory standards.
- Sample Size for Test Set: Not applicable in the context of clinical images or patient data. The "sample" would be the specific new detector models (CXDI-803C Wireless, CXDI-820C Wireless, CXDI-420C Wireless) and the updated firmware/software.
- Data Provenance: Not applicable for a clinical test set. The validation data would come from internal Canon testing (bench testing, engineering tests) to ensure the new components perform as expected and meet regulatory standards. This is typically prospective in nature, as new components are being evaluated for the first time. The manufacturing origin is Japan (Canon Inc., Japan).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. Since no clinical testing with patient images was deemed necessary, no experts (like radiologists) were used for establishing ground truth on a clinical test set. The "ground truth" for this submission relates to the functional and safety performance of the hardware and software, established through engineering validation and adherence to technical standards.
4. Adjudication Method for the Test Set
Not applicable. No clinical case review requiring adjudication by multiple experts was performed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC study was not done. The submission explicitly states "Clinical testing is not necessary." This type of study would be performed to evaluate the human-in-the-loop performance of an AI-assisted device, which is not the nature of this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
While the device itself is a digital radiography system (which essentially is a standalone imaging algorithm/device), there isn't a separate "AI algorithm" being evaluated independently in this submission. The device's performance is fundamental to its imaging capabilities, not an additional AI feature. The "performance" assessment focuses on the image quality metrics and safety standards of the detector and its processing, which are inherent to its "standalone" operation as an X-ray imager.
7. The Type of Ground Truth Used
The "ground truth" for this submission is:
- Engineering Specifications and Performance Standards: The device's performance (e.g., spatial resolution, DQE, IP level, wireless communication) is measured against predetermined technical specifications and international standards (IEC).
- Predicate Device Equivalence: The primary "ground truth" for this Special 510(k) is the demonstrated safety and effectiveness of the previously cleared predicate device (K222661). The new submission aims to prove that the changes do not alter this established equivalence.
8. The Sample Size for the Training Set
Not applicable. This device is a digital X-ray detector and associated software, not an AI model that requires a "training set" of medical images in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for an AI model in this submission.
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February 15, 2023
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Canon, USA Inc. % Saori Sawaki Business Manager/Regulatory Consultant Ken Block Consulting LLC 800 E Campbell Road, Suite 202 RICHARDSON TX 75081
Re: K230175
Trade/Device Name: Digital Radiography CXDI-CS01 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary X-Ray System Regulatory Class: Class II Product Code: MQB Dated: January 20, 2023 Received: January 20, 2023
Dear Saori Sawaki:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Lu Jiang
Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K230175
Device Name DIGITAL RADIOGRAPHY CXDI-CS01
Indications for Use (Describe)
The DIGITAL RADIOGRAPHY CXDI-CS01 provides digital image capture for conventional film/screen radiographic examinations. This device is intended to capture, for display, radiographic images of human anatomy, and to replace radiographic film/screen systems in all general purpose diagnostic procedures. This device is not intended for mammography applications.
| Type of Use (Select one or both, as applicable) | Prescription Use (Part 21 CFR 201 Subpart D)Over-The-Counter Use (21 CFR 201 Subpart G) | Prescription Use (Part 21 CFR 201 Subpart D) | Over-The-Counter Use (21 CFR 201 Subpart G) | ||
|---|---|---|---|---|---|
| Prescription Use (Part 21 CFR 201 Subpart D) | Over-The-Counter Use (21 CFR 201 Subpart G) | ||||
Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
K230175
| Applicant/ Sponsor: Canon Inc. |
|---|
| 9-1 Imaikami-cho |
| Nakahara-ku, Kanagawa 211-8501 JAPAN |
| Contact Person: | Mr. Akira HiraiGeneral ManagerTEL: 81-3-3758-2111FAX: 81-44-739-6695hirai.akira@mail.canon | |
|---|---|---|
| Date Prepared: | February 10, 2023 | |
| Subject Device | Manufacturer: Canon Inc.Trade Name: DIGITAL RADIOGRAPHY CXDI-CS01Common Name: Solid State X-Ray Imager (Flat Panel/Digital Imager)Classification Name: Stationary X-ray SystemProduct Code: MQBRegulation: 892.1680, Stationary x-ray systemClass: II | |
| Predicate Device: | Clearance: K222661 dated September 27, 2022Manufacturer: Canon Inc.Trade Name: DIGITAL RADIOGRAPHY CXDI-CS01Common Name: Solid State X-Ray Imager (Flat Panel/Digital Imager)Classification Name: Stationary X-ray SystemProduct Code: MQBRegulation: 892.1680, Stationary x-ray systemClass: II | |
| DeviceDescription: | The DIGITAL RADIOGRAPHY CXDI-CS01 (hereinafter referred to as CXDI-CS01) is a solid-state x-ray imager. The CXDI-CS01 is a series of detectors and, inthe predicate device submission (K222661), consists of the CXDI-702C Wireless,CXDI-402C Wireless, CXDI-710C Wireless, CXDI-810C Wireless, CXDI-410CWireless, DIGITAL RADIOGRAPHY CXDI-Pro (CXDI-703C Wireless andCXDI-403C Wireless), and DIGITAL RADIOGRAPHY CXDI-Elite (CXDI-720CWireless).The CXDI-CS01 intercepts x-ray photons, and the scintillator emits visiblespectrum photons that illuminate an array of photodetectors that create electricalsignals. After the electrical signals are generated, the signals are converted to digitalvalues. The digital values are sent to the PC via a wired or wireless connection,converted to images with the CXDI Control Software, and then displayed on thePC/monitors. The PC/monitors used with the CXDI-CS01 are not a part of thissubmission.The subject of this Special 510(k) submission is the changes to the predicate CXDI-CS01, which include the addition of the DIGITAL RADIOGRAPHY CXDI-Prodetector (CXDI-803C Wireless) and the DIGITAL RADIOGRAPHY CXDI-Elitedetectors (CXDI-820C Wireless and CXDI-420C Wireless) to the CXDI-CS01series of detectors, a firmware update of the DIGITAL RADIOGRAPHY CXDI-Proand DIGITAL RADIOGRAPHY CXDI-Elite detectors from 01.01.03.00 to01.02.00.01 and from F2.00.03.00 to 02.01.04.00 respectively, and a CXDI Control |
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| 510(k) Summary | K230175 |
|---|---|
| Software version update from V3.10.2.2 to V3.10.2.6 to fix bugs. Together, these changes make up the CXDI-CS01. | |
| Indications for Use: | The DIGITAL RADIOGRAPHY CXDI-CS01 provides digital image capture for conventional film/screen radiographic examinations. This device is intended to capture, for display, radiographic images of human anatomy, and to replace radiographic film/screen systems in all general purpose diagnostic procedures. This device is not intended for mammography applications. |
| Summary of Technological Characteristics: | Comparison with the predicate device shows the technological characteristics of the proposed CXDI-CS01 is substantially equivalent to the predicate device. The major differences between the proposed CXDI-CS01 and the predicate are differences in the components and a newer version of the CXDI control software. The proposed indications for use statement is identical to the indications for use statement of the predicate device. |
| New Device | Predicate Device | |
|---|---|---|
| Trade Name | DIGITAL RADIOGRAPHY CXDI-CS01 | DIGITAL RADIOGRAPHY CXDI-CS01 |
| 510(k)Submitter[Number] | Canon Inc.[K230175] | Canon Inc.[K222661] |
| Indications forUse | The DIGITAL RADIOGRAPHY CXDI-CS01 providesdigital image capture for conventional film/screenradiographic examinations. This device is intended tocapture, for display, radiographic images of human anatomy,and to replace radiographic film/screen systems in all generalpurpose diagnostic procedures. This device is not intendedfor mammography applications. | The DIGITAL RADIOGRAPHY CXDI-CS01 providesdigital image capture for conventional film/screenradiographic examinations. This device is intended tocapture, for display, radiographic images of human anatomy,and to replace radiographic film/screen systems in all generalpurpose diagnostic procedures. This device is not intendedfor mammography applications. |
| Application | General Radiography | General Radiography |
| Software | CXDI Control Software V3.10.2.6 | CXDI Control Software V3.10.2.2 |
| Components | DetectorsBattery Pack (LB-4A)Battery Charger (BC-1A/BC-01)Multi Box (MB-4A/MB-02)Power Box (PB-01)Ready Indicator (RI-3A)Status Indicator (SI-4A/SI-01)Wiring Cable (WC-4A/WC-01)PC Connection Cable (CP-4A/CP-01)Docking Station (DS-4A)Detector Stand (DS-01) | DetectorsBattery Pack (LB-4A)Battery Charger (BC-1A/BC-01)Multi Box (MB-4A/MB-02)Power Box (PB-01)Ready Indicator (RI-3A)Status Indicator (SI-4A/SI-01)Wiring Cable (WC-4A/WC-01)PC Connection Cable (CP-4A/CP-01)Docking Station (DS-4A)Detector Stand (DS-01) |
| Detector | CXDI-702C WirelessCXDI-402C WirelessCXDI-710C WirelessCXDI-810C WirelessCXDI-410C WirelessCXDI-Pro:CXDI-703C WirelessCXDI-803C WirelessCXDI-403C WirelessCXDI-Elite:CXDI-720C WirelessCXDI-420C WirelessCXDI-820C Wireless | CXDI-702C WirelessCXDI-402C WirelessCXDI-710C WirelessCXDI-810C WirelessCXDI-410C WirelessCXDI-Pro:CXDI-703C WirelessCXDI-803C WirelessCXDI-403C WirelessCXDI-Elite:CXDI-720C Wireless |
| New Device | Predicate Device | |
| Trade Name | DIGITAL RADIOGRAPHY CXDI-CS01 | DIGITAL RADIOGRAPHY CXDI-CS01 |
| Scintillator | CsI(Tl)[Cesium Iodide doped with Thallium] | CsI(Tl)[Cesium Iodide doped with Thallium] |
| CXDI-702C Wireless, CXDI-402C Wireless, CXDI-710CWireless, CXDI-810C Wireless, CXDI-410C Wireless, andCXDI-Elite: | CXDI-702C Wireless, CXDI-402C Wireless, CXDI-710CWireless, CXDI-810C Wireless, CXDI-410C Wireless, andCXDI-Elite: | |
| Pixel Pitch | 125μm | 125μm |
| CXDI-Pro: | CXDI-Pro: | |
| 140 μm | 140 μm | |
| CXDI-702C Wireless, CXDI-402C Wireless, CXDI-710CWireless, CXDI-810C Wireless, CXDI-410C Wireless, andCXDI-Pro: | CXDI-702C Wireless, CXDI-402C Wireless, CXDI-710CWireless, CXDI-810C Wireless, CXDI-410C Wireless, andCXDI-Pro: | |
| SpatialResolution | 35% [MTF@2lp/mm] | 35% [MTF@2lp/mm] |
| CXDI-Elite: | CXDI-Elite: | |
| 45% [MTF@2lp/mm]CXDI-702C Wireless: | 45% [MTF@2lp/mm]CXDI-702C Wireless: | |
| 58% [@0.5 lp/mm, 1 mR] | 58% [@0.5 lp/mm, 1 mR] | |
| CXDI-402C Wireless:58% [@0.5 lp/mm, 3.5 uGy] | CXDI-402C Wireless:58% [@0.5 lp/mm, 3.5 uGy] | |
| DQE | CXDI-710C Wireless, CXDI-810C Wireless, and CXDI-410C Wireless:60% [@0 lp/mm, 4 uGy] | CXDI-710C Wireless, CXDI-810C Wireless, and CXDI-410C Wireless:60% [@0 lp/mm, 4 uGy] |
| CXDI-Pro: | CXDI-Pro: | |
| 58% [@0.5 lp/mm, 3.5 uGy] | 58% [@0.5 lp/mm, 3.5 uGy] | |
| CXDI-Elite: | CXDI-Elite: | |
| 67% [@0.5 lp/mm, 3.5 uGy] | 67% [@0.5 lp/mm, 3.5 uGy] | |
| CXDI-702C Wireless and CXDI-402C Wireless IP54CXDI-710C Wireless, CXDI-810C Wireless, and CXDI-410C Wireless: | CXDI-702C Wireless and CXDI-402C Wireless IP54CXDI-710C Wireless, CXDI-810C Wireless, and CXDI-410C Wireless | |
| IP Level | IPX7 | IPX7 |
| CXDI-Pro: | CXDI-Pro: | |
| IP55 | IP55 | |
| CXDI-Elite: | CXDI-Elite: | |
| IP57 | IP57 | |
| CXDI-702C Wireless, CXDI-402C Wireless, CXDI-710CWireless, CXDI-810C Wireless, and CXDI-410C Wireless: | CXDI-702C Wireless, CXDI-402C Wireless, CXDI-710CWireless, CXDI-810C Wireless, and CXDI-410C Wireless: | |
| WirelessCommunication | IEEE 802.11n2.4GHz/5GHz | IEEE 802.11n2.4GHz/5GHz |
| CXDI-Pro and CXDI-Elite: | CXDI-Pro and CXDI-Elite: | |
| IEEE 802.11a/b/g/n/ac | IEEE 802.11a/b/g/n/ac | |
| 2.4GHz/5GHzBluetooth Low Energy | 2.4GHz/5GHzBluetooth Low Energy | |
| CXDI-702C Wireless, CXDI-402C Wireless, and CXDI-Pro: | CXDI-702C Wireless, CXDI-402C Wireless, and CXDI-Pro: | |
| Standard Synchronization Mode andNon Generator Connection Mode | Standard Synchronization Mode andNon Generator Connection Mode | |
| CXDI-710C Wireless, CXDI-810C Wireless, and CXDI-410C Wireless: | CXDI-710C Wireless, CXDI-810C Wireless, and CXDI-410C Wireless: | |
| PhotographingMode | Standard Synchronization Mode,Non Generator Connection Mode, and Standalone Mode | Standard Synchronization Mode,Non Generator Connection Mode, and Standalone Mode |
| CXDI-Elite: | CXDI-Elite: | |
| Standard Synchronization Mode,Standard Synchronization Mode with Built in AECAssistance,Non Generator Connection Mode, andStandalone Mode | Standard Synchronization Mode,Standard Synchronization Mode with Built in AECAssistance,Non Generator Connection Mode, andStandalone Mode |
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510(k) Summary
K230175
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510(k) Summary
K230175
The fundamental scientific technology of the CXDI-CS01 has not been modified. Summary of The major change is the addition of new detectors and component. Non-Clinical/ Test Data: Evaluation of the addition of the new detectors confirmed that the change did not impact the conformance of CXDI-CS01 with the U.S. Performance Standard for radiographic equipment and relevant voluntary safety standards for Electrical safety and Electromagnetic Compatibility testing, specifically IEC standards 60601-1, 60601-1-2, 60601-1-3, 60601-1-6, 60601-2-54, 62220-1, 62304, and 62366. The design control activities and biocompatibility evaluation successfully demonstrated that the modifications to the predicate device raise no new questions regarding either safety or effectiveness. Clinical testing is not necessary for the current submission, based on the minor differences from the predicate device. Adequate detector bench testing should be sufficient to demonstrate that the subject detector, CXDI-CS01, works as intended. Therefore, the verification/validation activities conducted support a determination of substantial equivalence for the CXDI-CS01. The proposed device follows the applicable elements of the following FDA guidance documents: Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices, Guidance for the Content of Premarket Submissions for Software contained in Medical Devices, Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", Radio Frequency Wireless Technology in Medical Devices, and Pediatric Information for X-ray Imaging Device Premarket Notifications. Conclusion: Canon Inc. considers the DIGITAL RADIOGRAPHY CXDI-CS01 device to be substantially equivalent to the predicate device listed above. This conclusion is based on the similarities in primary intended use, principles of operation, functional design, and established medical use.
§ 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.