(23 days)
No
The summary describes a standard digital radiography system and its components, focusing on hardware and software updates for image conversion and display. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is described as capturing and displaying radiographic images for diagnostic procedures, not for treating any condition.
Yes.
Explanation: 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 explicitly states that the device is a "solid-state x-ray imager" and describes hardware components like detectors, scintillators, and photodetectors. While it includes software (CXDI Control Software), it is an integral part of a larger hardware system for capturing and processing X-ray images.
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 to visualize internal structures of the body.
- Device Description: The description details how the device works by intercepting x-ray photons and converting them into digital images for display. This is consistent with a medical imaging system.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The provided text does not mention any interaction with biological specimens or analysis performed outside the body.
Therefore, the DIGITAL RADIOGRAPHY CXDI-Elite / E1 is a medical imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The DIGITAL RADIOGRAPHY CXDI-Elite / E1 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
MQB
Device Description
The DIGITAL RADIOGRAPHY CXDI-Elite, also called the DIGITAL RADIOGRAPHY E1, (hereinafter referred to as CXDI-Elite) is a solid-state x-ray imager. The CXDI-Elite is a series of detectors, and in the predicate device consists of the CXDI-720C Wireless detector (also called the AR-E3543W detector), the CXDI- 420C Wireless detector (also called the AR-E4343W detector), and the CXDI-420C Fixed detector (also called the AR-E4343S detector). 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. 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-Elite are not a part of this submission. The proposed changes to the predicate device, DIGITAL RADIOGRAPHY CXDI-Elite (K221620), include the addition of a new detector, the CXDI-820C Wireless (also called the AR-E2735W), to the CXDI-Elite series; the standardization of the thickness of CXDI-720C Wireless and CXDI-420C Wireless; the firmware update from F2.00.03.00 to 02.01.04.00; the CXDI Control Software version update from 3.10.2.2 to 3.10.2.6; and the addition of a 25 m of the CXDI-420C Fixed detector cable and a 10 m of Wiring Cable (WC-01). Together, these changes make up the CXDI-Elite.
Mentions image processing
Yes
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
The fundamental scientific technology of the CXDI-Elite has not been modified. The change is the addition of new detector CXDI-820C Wireless (AR-E2735W).
Evaluation of the addition of the new detector confirmed that the change did not impact CXDI-Elite 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, 60601-2-54, and 60601-1-6.
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-Elite / E1 works as intended. Therefore, the verification/validation activities conducted support a determination of substantial equivalence for the CXDI-Elite.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 29, 2022
Image /page/0/Picture/1 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
Canon Inc. % Ms. Saori Sawaki Business Manager, Regulatory Consultant Ken Block Consulting LLC 800 E Campbell Road. Suite 202 RICHARDSON TX 75081
Re: K222687
Trade/Device Name: Digital Radiography CXDI-Elite Digital Radiography E1 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary X-Ray System Regulatory Class: Class II Product Code: MQB Dated: September 6, 2022 Received: September 6, 2022
Dear Ms. 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.
1
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 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.
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)
Device Name DIGITAL RADIOGRAPHY CXDI-Elite DIGITAL RADIOGRAPHY E1
Indications for Use (Describe)
The DIGITAL RADIOGRAPHY CXDI-Elite / E1 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)
| Research Use (R, 21 CFR 821 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart G) |
Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/1 description: The image shows the word "Canon" in red font at the top. Below the word "Canon" is the text "510(k) SUMMARY" in a bold, black font. The text is centered below the word "Canon".
| 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 15, 2022 |
| Proposed Device | Manufacturer: Canon Inc. |
| Trade Name: DIGITAL RADIOGRAPHY CXDI-Elite DIGITAL RADIOGRAPHY E1 | |
| 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: K221620 |
| Manufacturer: Canon Inc. | |
| Trade Name: DIGITAL RADIOGRAPHY CXDI-Elite DIGITAL RADIOGRAPHY E1 | |
| 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-Elite, also called the DIGITAL RADIOGRAPHY E1, (hereinafter referred to as CXDI-Elite) is a solid-state x-ray imager. The CXDI-Elite is a series of detectors, and in the predicate device consists of the CXDI-720C Wireless detector (also called the AR-E3543W detector), the CXDI- 420C Wireless detector (also called the AR-E4343W detector), and the CXDI-420C Fixed detector (also called the AR-E4343S detector). 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. 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-Elite are not a part of this submission. The proposed changes to the predicate device, DIGITAL RADIOGRAPHY CXDI-Elite (K221620), include the addition of a new detector, the CXDI-820C Wireless (also called the AR-E2735W), to the CXDI-Elite series; the standardization of the thickness of CXDI-720C Wireless and CXDI-420C Wireless; the firmware update from F2.00.03.00 to 02.01.04.00; the CXDI Control Software version update from 3.10.2.2 to 3.10.2.6; and the addition of a 25 m of the CXDI-420C Fixed detector cable and a 10 m of Wiring Cable (WC-01). Together, these changes make up the CXDI-Elite. |
4
Image /page/4/Picture/0 description: The image shows the Canon logo in red, followed by the text "510(k) SUMMARY" in bold black font. The Canon logo is a stylized version of the company's name. The text "510(k) SUMMARY" is likely a reference to a regulatory document related to medical devices. The image is simple and straightforward, with a clear focus on the Canon brand and the regulatory context.
The DIGITAL RADIOGRAPHY CXDI-Elite / E1 provides digital image capture for Indications for Use: 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 Comparison with the predicate device shows the technological characteristics of the Technological CXDI-Elite is substantially equivalent to the predicate device. The flat panel detector Characteristics: units are functionally same, using the same components.
| Proposed Device | Predicate Device | ||
|---|---|---|---|
| Trade Name | DIGITAL RADIOGRAPHY CXDI-Elite / E1 | DIGITAL RADIOGRAPHY CXDI-Elite / E1 | |
| 510(k) Submitter | |||
| [Number] | Canon Inc. | ||
| [K222687] | Canon Inc. | ||
| [K221620] | IDENTICAL | ||
| Indication for Use | The DIGITAL RADIOGRAPHY CXDI-Elite / | ||
| E1 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-Elite / | ||
| E1 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 |
| Detector | CXDI-720C Wireless (AR-E3543W) | ||
| CXDI-420C Wireless (AR-E4343W) | |||
| CXDI-820C Wireless (AR-E2735W) | |||
| CXDI-420C Fixed (AR-E4343S) | CXDI-720C Wireless (AR-E3543W) | ||
| CXDI-420C Wireless (AR-E4343W) | |||
| CXDI-420C Fixed (AR-E4343S) | MODIFIED | ||
| Components | CXDI-720C Wireless, | ||
| CXDI-420C Wireless, and | |||
| CXDI-820C Wireless: | |||
| Detector (Sensor) | |||
| Battery Pack (LB-4A) | |||
| Battery Charger (BC-01/BC-1A) | |||
| Multi Box (MB-02) | |||
| Status Indicator (SI-01/SI-4A) | |||
| Wiring Cable, 1.5/7.5/10/15/25m (WC-01) | |||
| PC Connection Cable (CP-01) | |||
| Ready Indicator (RI-3A) | |||
| X-ray Interface Box (XB-1A) | |||
| Detector Stand (DS-01) | |||
| CXDI-420C Fixed: | |||
| Detector (Sensor) | |||
| Multi Box (MB-02) | |||
| Status Indicator (SI-01/SI-4A) | |||
| Ready Indicator (RI-3A) | |||
| X-ray Interface Box (XB-1A) | CXDI-720C Wireless and | ||
| CXDI-420C Wireless: | |||
| Detector (Sensor) | |||
| Battery Pack (LB-4A) | |||
| Battery Charger (BC-01/BC-1A) | |||
| Multi Box (MB-02) | |||
| Status Indicator (SI-01/SI-4A) | |||
| Wiring Cable, 1.5/7.5/15/25m (WC-01) | |||
| PC Connection Cable (CP-01) | |||
| Ready Indicator (RI-3A) | |||
| X-ray Interface Box (XB-1A) | |||
| Detector Stand (DS-01) | |||
| CXDI-420C Fixed: | |||
| Detector (Sensor) | |||
| Multi Box (MB-02) | |||
| Status Indicator (SI-01/SI-4A) | |||
| Ready Indicator (RI-3A) | |||
| X-ray Interface Box (XB-1A) | MODIFIED | ||
| Other Compatible | |||
| Components | Power Box (PB-01) | Power Box (PB-01) | IDENTICAL |
| Software | CXDI Control Software V3.10.2.6 | CXDI Control Software V3.10.2.2 | MODIFIED |
| Detector Firmware | 02.01.04.00 | F2.00.03.00 | MODIFIED |
| Pixel Pitch | 125µm | 125µm | IDENTICAL |
| Scintillator | CsI(Tl) | ||
| [Cesium Iodide doped with Thallium] | CsI(Tl) | ||
| [Cesium Iodide doped with Thallium] | IDENTICAL | ||
| Spatial | |||
| Resolution | 45% [MTF@2lp/mm] | 45% [MTF@2lp/mm] | IDENTICAL |
| IP Level | CXDI-720C Wireless: IP57 | ||
| CXDI-420C Wireless: IP57 | |||
| CXDI-820C Wireless: IP57 | |||
| CXDI-420C Fixed: N/A | CXDI-720C Wireless: IP57 | ||
| CXDI-420C Wireless: IP57 | |||
| CXDI-420C Fixed: N/A | MODIFIED | ||
| Wireless | |||
| Communication | IEEE 802.11a/b/g/n/ac | ||
| 2.4GHz/5GHz | |||
| Bluetooth Low Energy | |||
| (only for CXDI-720C Wireless, CXDI-420C | |||
| Wireless, and CXDI-820C Wireless) | IEEE 802.11a/b/g/n/ac | ||
| 2.4GHz/5GHz | |||
| Bluetooth Low Energy | |||
| (only for CXDI-720C Wireless and CXDI-420C | |||
| Wireless) | IDENTICAL | ||
| External | |||
| Dimensions | CXDI-720C Wireless: 384 x 460 x 15.7 mm | ||
| CXDI-420C Wireless: 460 x 460 x 15.7 mm | |||
| CXDI-820C Wireless: 384 x 307.5 x 15.7mm | |||
| CXDI-420C Fixed: 460 x 460 x 15.3 mm | CXDI-720C Wireless: 384 x 460 x 15.5 mm | ||
| CXDI-420C Wireless: 460 x 460 x 15.5 mm | |||
| CXDI-420C Fixed: 460 x 460 x 15.3 mm | MODIFIED | ||
| Photographing | |||
| Mode | Standard Synchronization Mode, | ||
| Standard Synchronization Mode with Built in | |||
| AEC Assistance, | |||
| Non Generator Connection Mode, | |||
| Standalone Mode (only for CXDI-720C | |||
| Wireless, CXDI-420C Wireless, and CXDI- | |||
| 820C Wireless) | Standard Synchronization Mode, | ||
| Standard Synchronization Mode with Built in | |||
| AEC Assistance, | |||
| Non Generator Connection Mode, | |||
| Standalone Mode (only for CXDI-720C | |||
| Wireless and CXDI-420C Wireless) | IDENTICAL |
5
Image /page/5/Picture/0 description: The image shows the word "Canon" in a large, red, bold font. Below the word "Canon" is the text "510(k) SUMMARY" in a smaller, black, bold font. The text is centered below the word "Canon".
Summary of Non-Clinical / Test Data:
The fundamental scientific technology of the CXDI-Elite has not been modified. The change is the addition of new detector CXDI-820C Wireless (AR-E2735W).
Evaluation of the addition of the new detector confirmed that the change did not impact CXDI-Elite 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, 60601-2-54, and 60601-1-6.
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-Elite / E1 works as intended. Therefore, the verification/validation activities conducted support a determination of substantial equivalence for the CXDI-Elite.
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.