(25 days)
Yes
The summary explicitly mentions the addition of the "Intelligent NR function" which was cleared under K212269. While the summary doesn't detail the function, the term "Intelligent" in the context of medical imaging often implies the use of AI/ML for noise reduction. The reference to K212269, which likely contains more details about this function, further supports this.
No.
The device is described as capturing, converting, and displaying radiographic images for diagnostic procedures, which is an imaging and diagnostic function, not a therapeutic one.
Yes
The "Intended Use / Indications for Use" section explicitly states that the 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."
No
The device description clearly states it is a "solid-state x-ray imager" and a "series of detectors," which are hardware components. While it includes software for image conversion and processing, the core medical device is the hardware that captures the x-ray photons.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "digital image capture for conventional film/screen radiographic examinations" and to "capture, for display, radiographic images of human anatomy." This describes an imaging device used on the patient, not a device used to examine samples from the patient (which is the core of IVD).
- Device Description: The description details how the device intercepts x-rays and converts them into digital images. This process is entirely focused on capturing images of the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.
The device is a digital radiography system, which is a type of medical imaging equipment used for diagnostic purposes, but it operates in vivo (on the living body) rather than in vitro (in a test tube or other artificial environment).
No
The letter does not explicitly state that the FDA has reviewed and approved or cleared a PCCP for this specific device. The provided text includes "Control Plan Authorized (PCCP) and relevant text Not Found", indicating no mention of PCCP authorization.
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
MQB
Device Description
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 (K203849) consists of the CXDI-702C Wireless, CXDI-402C Wireless, CXDI-710C Wireless, CXDI-810C Wireless, and CXDI-410C 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 a change to the CXDI-CS01 to add the DIGITAL RADIOGRAPHY CXDI-Pro (hereinafter referred to as CXDI-Pro) series and the DIGITAL RADIOGRAPHY CXDI-Elite (hereinafter referred to as CXDI-Elite) series detectors to the CXDI-CS01 series of detectors. In addition, the CXDI-Pro and CXDI-Elite components and features (Bluetooth connection and the Built-in AEC Assistance) have been added to the CXDI-CS01. The CXDI Control Software has been updated from V2.19.0.7 to V3.10.2.2 to add the Intelligent NR function (cleared under K212269), update the GPU driver, add several minor functional changes, and fix bugs. Together, these changes make up the CXDI-CS01.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray
Anatomical Site
human anatomy
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Evaluation of the addition of the new detectors confirmed that the change did not impact CXDI-CS01 conformance with the U.S. Performance Standard for radiographic equipment and with relevant voluntary safety standards for Electrical safety and Electromagnetic Compatibility testing, specifically IEC standards 60601-1, 60601-1-2, 60601-1-3, 60601-1-6, 60601-2-54, 62220-1, 62304, and 62366.
These verification/validation activities successfully demonstrated that the device continues to meet the standards for the areas impacted by the modifications to the predicate device and raises no new questions regarding either safety or effectiveness when compared to the predicate device. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
September 27, 2022
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below.
Canon Inc. % Saori Sawaki Business Manager, Regulatory Consultant Ken Block Consulting LLC 800 E Campbell Road. Suite 202 RICHARDSON TX 75081
Re: K222661
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: September 2, 2022 Received: September 2, 2022
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
1
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 mediation-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,
Laurel Burk, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K222661
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 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
| Applicant/ Sponsor: | Canon Inc.
9-1 Imaikami-cho
Nakahara-ku, Kanagawa 211-8501 JAPAN |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mr. Akira Hirai
General Manager
TEL: 81-3-3758-2111
FAX: 044-739-6695
hirai.akira@mail.canon |
| Date Prepared: | September 2, 2022 |
| Submission Type: | Special 510(k) Submission |
| Proposed Device | Manufacturer: Canon Inc.
Trade Name: DIGITAL RADIOGRAPHY CXDI-CS01
Common Name: Solid State X-Ray Imager (Flat Panel/Digital Imager)
Classification Name: Stationary X-ray System
Product Code: MQB
Regulation: 892.1680, Stationary X-ray System |
| Predicate Device: | Clearance: K203849
Manufacturer: Canon Inc.
Trade Name: DIGITAL RADIOGRAPHY CXDI-CS01
Common Name: Solid State X-ray Imager (Flat Panel/Digital Imager)
Classification Name: Stationary X-ray System
Product Code: MQB
Regulation: 892.1680, Stationary X-ray System |
| Device Description: | 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 (K203849) consists of the CXDI-702C Wireless, CXDI-402C Wireless, CXDI-710C Wireless, CXDI-810C Wireless, and CXDI-410C 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 a change to the CXDI-CS01 to add the DIGITAL RADIOGRAPHY CXDI-Pro (hereinafter referred to as CXDI-Pro) series and the DIGITAL RADIOGRAPHY CXDI-Elite (hereinafter referred to as CXDI-Elite) series detectors to the CXDI-CS01 series of detectors. In addition, the CXDI-Pro and CXDI-Elite components and features (Bluetooth connection and the Built-in AEC Assistance) have been added to the CXDI-CS01. The CXDI Control Software has been updated from V2.19.0.7 to V3.10.2.2 to add the Intelligent NR function (cleared under K212269), update the GPU driver, add several minor functional changes, and 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. |
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Image /page/4/Picture/0 description: The image shows the Canon logo in red, followed by the text "510(k) SUMMARY" in black. The Canon logo is a stylized version of the company's name. The text "510(k) SUMMARY" is in a simple, sans-serif font. The image is likely from a document related to a medical device or product.
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.
| Proposed Device | Predicate Device | ||
|---|---|---|---|
| Trade Name | DIGITAL RADIOGRAPHY CXDI-CS01 | DIGITAL RADIOGRAPHY CXDI-CS01 | |
| 510(k) Submitter | |||
| [Number] | Canon Inc. | ||
| [TBD] | Canon Inc. | ||
| [K203849] | IDENTICAL | ||
| Indication 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. | 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. | IDENTICAL | ||
| Application | General Radiography | General Radiography | IDENTICAL |
| Software | CXDI Control Software V3.10 | CXDI Control Software V2.19 | MODIFIED |
| Components | Detectors | ||
| Battery 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) | Detectors | ||
| Battery Pack (LB-4A) | |||
| Battery Charger (BC-1A) | |||
| Multi Box (MB-4A) | |||
| Ready Indicator (RI-3A) | |||
| Status Indicator (SI-4A) | |||
| Wiring Cable (WC-4A) | |||
| PC Connection Cable (CP-4A) | |||
| Docking Station (DS-4A) | MODIFIED | ||
| Detector | CXDI-702C Wireless | ||
| CXDI-402C Wireless | |||
| CXDI-710C Wireless | |||
| CXDI-810C Wireless | |||
| CXDI-410C Wireless | |||
| CXDI-Pro: | |||
| CXDI-703C Wireless | |||
| CXDI-403C Wireless | |||
| CXDI-Elite: | |||
| CXDI-720C Wireless | CXDI-702C Wireless | ||
| CXDI-402C Wireless | |||
| CXDI-710C Wireless | |||
| CXDI-810C Wireless | |||
| CXDI-410C Wireless | MODIFIED | ||
| Scintillator | CsI(Tl) | ||
| [Cesium Iodide doped with Thallium] | CsI(Tl) | ||
| [Cesium Iodide doped with Thallium] | IDENTICAL | ||
| Pixel Pitch | CXDI-702C Wireless, CXDI-402C Wireless, | ||
| CXDI-710C Wireless, CXDI-810C Wireless, | |||
| CXDI-410C Wireless, and CXDI-Elite: | |||
| 125μm | |||
| CXDI-Pro: | |||
| 140 μm | CXDI-702C Wireless, CXDI-402C Wireless, | ||
| CXDI-710C Wireless, CXDI-810C Wireless, | |||
| CXDI-410C Wireless: | |||
| 125μm | MODIFIED | ||
| Spatial | |||
| Resolution | CXDI-702C Wireless, CXDI-402C Wireless, | ||
| CXDI-710C Wireless, CXDI-810C Wireless, | |||
| and CXDI-410C Wireless: | |||
| 35% [MTF@2lp/mm] | |||
| CXDI-Pro and CXDI-Elite: | |||
| 45% [MTF@2lp/mm] | CXDI-702C Wireless, CXDI-402C Wireless, | ||
| CXDI-710C Wireless, CXDI-810C Wireless, | |||
| CXDI-410C Wireless: | |||
| 35% [MTF@2lp/mm] | MODIFIED | ||
| Proposed Device | Predicate Device | ||
| Trade Name | DIGITAL RADIOGRAPHY CXDI-CS01 | DIGITAL RADIOGRAPHY CXDI-CS01 | |
| 510(k) Submitter | |||
| [Number] | Canon Inc. | ||
| [TBD] | Canon Inc. | ||
| [K203849] | IDENTICAL | ||
| DQE | CXDI-702C Wireless: | ||
| 58% [@0.5 lp/mm, 1 mR] | CXDI-702C Wireless: | ||
| 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] | |||
| 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] | MODIFIED | ||
| CXDI-Pro: | |||
| 58% [@0.5 lp/mm, 3.5 uGy] | |||
| CXDI-Elite: | |||
| 67% [@0.5 lp/mm, 3.5 uGy] | |||
| IP Level | CXDI-702C Wireless and CXDI-402C Wireless | ||
| IP54 | CXDI-702C Wireless and CXDI-402C Wireless | ||
| IP54 | |||
| CXDI-710C Wireless, CXDI-810C Wireless, | |||
| and CXDI-410C Wireless | |||
| IPX7 | CXDI-710C Wireless, CXDI-810C Wireless, | ||
| and CXDI-410C Wireless | |||
| IPX7 | MODIFIED | ||
| CXDI-Pro: | |||
| IP55 | |||
| CXDI-Elite: | |||
| IP57 | |||
| Wireless | |||
| Communication | CXDI-702C Wireless, CXDI-402C Wireless, | ||
| CXDI-710C Wireless, CXDI-810C Wireless, | |||
| and CXDI-410C Wireless: | |||
| IEEE 802.11n | |||
| 2.4GHz/5GHz | CXDI-702C Wireless, CXDI-402C Wireless, | ||
| CXDI-710C Wireless, CXDI-810C Wireless, | |||
| and CXDI-410C Wireless: | |||
| IEEE 802.11n | |||
| 2.4GHz/5GHz | MODIFIED | ||
| CXDI-Pro and CXDI-Elite: | |||
| IEEE 802.11a/b/g/n/ac | |||
| 2.4GHz/5GHz | |||
| Bluetooth Low Energy | |||
| Photographing Mode | CXDI-702C Wireless, CXDI-402C Wireless, | ||
| and CXDI-Pro: | |||
| Standard Synchronization Mode and | |||
| Non Generator Connection Mode | CXDI-702C Wireless and CXDI-402C Wireless: | ||
| Standard Synchronization Mode and | |||
| Non Generator Connection Mode | |||
| CXDI-710C Wireless, CXDI-810C Wireless, | |||
| and CXDI-410C Wireless: | |||
| Standard Synchronization Mode, | |||
| Non Generator Connection Mode, and | |||
| Standalone Mode | CXDI-710C Wireless, CXDI-810C Wireless, | ||
| and CXDI-410C Wireless: | |||
| Standard Synchronization Mode, | |||
| Non Generator Connection Mode, and | |||
| Standalone Mode | MODIFIED | ||
| CXDI-Elite: | |||
| Standard Synchronization Mode, | |||
| Standard Synchronization Mode with Built in | |||
| AEC Assistance, | |||
| Non Generator Connection Mode, and | |||
| Standalone Mode | |||
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Image /page/5/Picture/0 description: The image shows the Canon logo in red, with the text "510(k) SUMMARY" in black below it. The Canon logo is a stylized version of the company's name. The text "510(k) SUMMARY" is in a bold, sans-serif font. The image is likely from a document related to a medical device submission to the FDA.
The fundamental scientific technology of the CXDI-CS01 has not been modified. The Summary of Non-Clinical / change is the addition of the CXDI-Pro series and the CXDI-Elite series detectors and Test Data: components.
Evaluation of the addition of the new detectors confirmed that the change did not impact CXDI-CS01 conformance with the U.S. Performance Standard for radiographic equipment and with relevant voluntary safety standards for Electrical safety and
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Image /page/6/Picture/0 description: The image shows the word "Canon" in red, with a stylized font. Below the word "Canon" is the text "510(k) SUMMARY" in a smaller, black, sans-serif font. The text is left-aligned and appears to be part of a document or report.
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.
These verification/validation activities successfully demonstrated that the device continues to meet the standards for the areas impacted by the modifications to the predicate device and raises no new questions regarding either safety or effectiveness when compared to the predicate device. 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.
Canon Inc. considers the DIGITAL RADIOGRAPHY CXDI-CS01 device to be Conclusion: 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.