(26 days)
No
The summary describes standard digital radiography technology and image processing, with no mention of AI or ML. The changes described relate to hardware components and software versioning, not advanced algorithms.
No
This device is an X-ray detector used for diagnostic imaging, not for treating diseases or conditions.
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 series of solid-state x-ray detectors, which are hardware components. While it includes software for image conversion, the core device is hardware.
Based on the provided information, 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 in vivo (within the living body) to visualize internal structures.
- Device Description: The description details how the device intercepts x-ray photons and converts them into electrical signals for image display. This process is consistent with medical imaging, not in vitro testing of biological samples.
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples such as blood, urine, or tissue to detect diseases or other conditions. This device does not perform any such tests on biological samples.
Therefore, the DIGITAL RADIOGRAPHY CXDI-CS01 is a medical imaging device, not an In Vitro Diagnostic device.
N/A
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 is a series of solid-state x-ray detectors. 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 digital values are sent to the PC via wired or wireless connection, converted to images with the CXDI Control Software (CCS), then 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-702C Wireless and CXDI-402C Wireless to make a series of detectors including the DIGITAL RADIOGRAPHY CXDI-702C Wireless (K192632), CXDI-402C Wireless (K192632), CXDI-710C Wireless (K170332), CXDI-810C Wireless (K170332), and CXDI-410C Wireless (K171270), under the proposed device the DIGITAL RADIOGRAPHY CXDI-CS01. This change will change the Multi Box to be a Standard Component from an optional component for the detectors. The Multi Box has the functions of connecting to the X-ray generator to synchronize the X-ray exposure and photographing, supplying power to the FPD (front panel detector), communicating between the FPD and the image capture computer, connecting the status indicator to the Multi Box to turn the FPD on and off and switch to a ready state, connecting to the WLAN access point to communicate to the FPD wirelessly, and connecting to the docking station to charge the FPD and communicate between the FPD and image capture computer. These functions of the Multi Box have not changed since its clearance under the predicate device (K192632). The X-ray I/F (Interface) Unit has been removed as an optional component for the DIGITAL RADIOGRAPHY CXDI-702C Wireless and CXDI-402C Wireless as the Multi Box performs the function of the X-ray I/F Unit (connecting to the X-ray generator to synchronize the x-ray exposure and photographing). In addition, the detectors will all use the version software cleared under the DIGITAL RADIOGRAPHY CXDI-702C Wireless and CXDI-402C Wireless (K192632). Together, these changes make up the DIGITAL RADIOGRAPHY CXDI-CS01.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Evaluation of the changes to the DIGITAL RADIOGRAPHY CXDI-CS01 confirmed that the changes did not impact DIGITAL RADIOGRAPHY 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, 62366, 60601-2-54, 62220-1, and 62304. 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 conducted supports a determination of substantial equivalence for the DIGITAL RADIOGRAPHY CXDI-CS01 device.
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
January 26, 2021
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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Canon Inc. % Mr. Gregory Woodard Biomedical Engineer Ken Block Consulting, LLC 800 East Campbell Road, Suite 202 RICHARDSON TX 75081
Re: K203849
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: December 30, 2020 Received: December 31, 2020
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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
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.
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
2
Indications for Use
510(k) Number (if known)
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) |
|---|---|
| ---------------------------------------------- | --------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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3
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 easily readable and stands out against the white background.
510(k) SUMMARY
| K203849 | ||
|---|---|---|
| Submitter: | Canon Inc. | |
| 30-2 Shimomaruko, 3-chrome | ||
| Ohta-ku, Tokyo 146-8501 Japan | ||
| Contact Person: | Mr. Akira Hirai | |
| General Manager | ||
| TEL: 81-3-3758-2111; | ||
| FAX: 044-739-6695 | ||
| hirai.akira@mail.canon | ||
| Date Prepared: | 12/30/2020 | |
| Submission Type: | Special 510(k) Submission | |
| Proposed Device: | Manufacturer: | |
| Trade Name: | ||
| Common Name: | ||
| Classification Name: | ||
| Classification: | ||
| Product Code: | Canon Inc. | |
| DIGITAL RADIOGRAPHY CXDI-CS01 | ||
| Solid State X-Ray Imager (Flat Panel/Digital Imager) | ||
| Stationary X-ray System | ||
| 892.1680, Stationary X-ray System | ||
| MQB | ||
| Predicate Device: | 510k Number: | |
| Manufacturer: | ||
| Trade Name: | ||
| Common Name: | ||
| Classification Name: | ||
| Classification: | ||
| Product Code: | K192632 | |
| Canon, Inc. | ||
| DIGITAL RADIOGRAPHY CXDI-702C Wireless, | ||
| CXDI-402C Wireless | ||
| Solid State X-Ray Imager (Flat Panel/Digital Imager) | ||
| Stationary X-ray System | ||
| 892.1680, Stationary X-ray System | ||
| MQB | ||
| Reference Devices: | 510k Number: | |
| Manufacturer: | ||
| Trade Name: | ||
| Common Name: | ||
| Classification Name: | ||
| Classification: | ||
| Product Code: | K171270 | |
| Canon, Inc. | ||
| DIGITAL RADIOGRAPHY CXDI-410C Wireless | ||
| Solid State X-Ray Imager (Flat Panel/Digital Imager) | ||
| Stationary X-ray System | ||
| 892.1680, Stationary X-ray System | ||
| MQB | ||
| 510k Number: | ||
| Manufacturer: | ||
| Trade Name: | ||
| Common Name: | ||
| Classification Name: | ||
| Classification: | K170332 | |
| Canon, Inc. | ||
| DIGITAL RADIOGRAPHY CXDI-810C Wireless, | ||
| CXDI-710C Wireless | ||
| Solid State X-ray Imager | ||
| Stationary X-ray System | ||
| 892.1680, Stationary X-ray System |
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Image /page/4/Picture/0 description: The image shows the word "Canon" in red font. The font is bold and slightly italicized. The background is white.
Product Code: MQB
Device Description: The DIGITAL RADIOGRAPHY CXDI-CS01 is a series of solid-state x-ray detectors. 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 digital values are sent to the PC via wired or wireless connection, converted to images with the CXDI Control Software (CCS), then 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-702C Wireless and CXDI-402C Wireless to make a series of detectors including the DIGITAL RADIOGRAPHY CXDI-702C Wireless (K192632), CXDI-402C Wireless (K192632), CXDI-710C Wireless (K170332), CXDI-810C Wireless (K170332), and CXDI-410C Wireless (K171270), under the proposed device the DIGITAL RADIOGRAPHY CXDI-CS01. This change will change the Multi Box to be a Standard Component from an optional component for the detectors. The Multi Box has the functions of connecting to the X-ray generator to synchronize the X-ray exposure and photographing, supplying power to the FPD (front panel detector), communicating between the FPD and the image capture computer, connecting the status indicator to the Multi Box to turn the FPD on and off and switch to a ready state, connecting to the WLAN access point to communicate to the FPD wirelessly, and connecting to the docking station to charge the FPD and communicate between the FPD and image capture computer. These functions of the Multi Box have not changed since its clearance under the predicate device (K192632). The X-ray I/F (Interface) Unit has been removed as an optional component for the DIGITAL RADIOGRAPHY CXDI-702C Wireless and CXDI-402C Wireless as the Multi Box performs the function of the X-ray I/F Unit (connecting to the X-ray generator to synchronize the x-ray exposure and photographing). In addition, the detectors will all use the version software cleared under the DIGITAL RADIOGRAPHY CXDI-702C Wireless and CXDI-402C Wireless (K192632). Together, these changes make up the DIGITAL RADIOGRAPHY CXDI-CS01.
Indication for Use: The Indication for Use statement is identical to the predicate device. 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-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/5/Picture/0 description: The image contains the word "Canon" in a bold, red font. The word is slightly stylized, with a unique design for each letter. The background is plain white, which makes the red text stand out.
Summary of Technological Characteristics: Comparisons with the predicate devices show the characteristics of the proposed modifications (making the Multi Box a standard component, removing the X-ray I/F Interface as an option, and updating the CXDI Control Software to version 2.19) to the DIGITAL RADIOGRAPHY CXDI-CS01 to be substantially equivalent to the predicate device.
| Proposed Device | Predicate Device | Reference Devices | ||
|---|---|---|---|---|
| Trade Name | CXDI-CS01 | CXDI-702C Wireless / | ||
| CXDI-402C Wireless | CXDI-710C Wireless / CXDI- | |||
| 810C Wireless / CXDI-410C | ||||
| Wireless | ||||
| 510(k) | ||||
| Submitter | ||||
| [Number] | Canon, Inc. | |||
| [TBD] | Canon, Inc. | |||
| [K192632] | Canon, Inc. | |||
| [K170332] | ||||
| [K171270] | 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- | ||||
| 402C Wireless and | ||||
| DIGITAL RADIOGRAPHY | ||||
| CXDI-702C 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 DIGITAL | |||
| RADIOGRAPHY CXDI-710C | ||||
| Wireless, DIGITAL | ||||
| RADIOGRAPHY CXDI-810C | ||||
| Wireless, and DIGITAL | ||||
| RADIOGRAPHY CXDI-410C | ||||
| Wireless provides digital image | ||||
| capture for conventional | ||||
| film/screen radiographic | ||||
| examinations. This device is | ||||
| intended to capture, for display, | ||||
| radiographic images of human | ||||
| anatomy, and to replace | ||||
| radiographic film/screen | ||||
| systems in all general purpose | ||||
| diagnostic procedures. This | ||||
| device is not intended for | ||||
| mammography applications. | IDENTICAL | |||
| Application | General Radiography | General Radiography | General Radiography | IDENTICAL |
| Case Material | [Detector of CXDI-702C | |||
| Wireless and CXDI-402C | ||||
| Wireless] | ||||
| Magnesium alloy | ||||
| [Detector of CXDI-710C | ||||
| Wireless. CXDI-810C | ||||
| Wireless and CXDI-410C | ||||
| Wireless] | ||||
| Carbon Fiber | Magnesium alloy | Carbon Fiber | IDENTICAL | |
| Scintillator | CsI(Tl) | |||
| [Cesium Iodide doped with | ||||
| Thallium] | CsI(TI) | |||
| [Cesium Iodide doped with | ||||
| Thallium] | CsI(Tl) | |||
| [Cesium Iodide doped with | ||||
| Thallium] | IDENTICAL | |||
| Pixel Pitch | 125μm | 125μm | 125μm | IDENTICAL |
| Spatial | ||||
| Resolution | 35% [MTF@2lp/mm] | 35% [MTF@2lp/mm] | 35% [MTF@2lp/mm] | IDENTICAL |
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Image /page/6/Picture/0 description: The image shows the word "Canon" in red font. The font is bold and slightly blurred. The background is white.
Performance:
| Proposed Device | Predicate Device | Reference Devices | ||
|---|---|---|---|---|
| Trade Name | CXDI-CS01 | CXDI-702C Wireless / | ||
| CXDI-402C Wireless | CXDI-710C Wireless / CXDI- | |||
| 810C Wireless / CXDI-410C | ||||
| Wireless | ||||
| IP Level | [Detector of CXDI-702C | |||
| Wireless and CXDI-402C | ||||
| Wireless] | ||||
| IP54 | ||||
| [Detector of CXDI-710C | ||||
| Wireless, CXDI-810C | ||||
| Wireless and CXDI-410C | ||||
| Wireless] | ||||
| IPX7 | IP54 | IPX7 | IDENTICAL | |
| Standard | ||||
| Components | Detectors (Sensors), Battery | |||
| Pack, | ||||
| Documentation (Manuals), | ||||
| Multi Box | Detector (Sensor), Battery | |||
| Pack, | ||||
| Documentation (Manuals) | Detector (Sensor), Battery Pack, | |||
| Documentation (Manuals) | MODIFIED | |||
| Options | Docking Station, Battery | |||
| Charger, Battery Pack, | ||||
| Status Indicator, Wiring | ||||
| Cable, PC Connection | ||||
| Cable, Ready Indicator | Docking Station, Battery | |||
| Charger, Battery Pack, | ||||
| Multi Box, Status Indicator, | ||||
| Wiring Cable, PC | ||||
| Connection Cable, Ready | ||||
| Indicator, X-ray I/F unit | Docking Station, Battery | |||
| Charger, Battery Pack, Multi | ||||
| Box, Status Indicator, Wiring | ||||
| Cable, PC Connection Cable, | ||||
| Ready Indicator | MODIFIED | |||
| Software | CXDI Control Software | |||
| V2.19 | CXDI Control Software | |||
| V2.19 | CXDI Control Software V2.16 | MODIFIED | ||
| Photographing | ||||
| Mode | [Detector of CXDI-702C | |||
| Wireless and CXDI-402C | ||||
| Wireless] | ||||
| Standard Synchronization | ||||
| Mode, Non Generator | ||||
| Connection Mode | ||||
| [Detector of CXDI-710C | ||||
| Wireless, CXDI-810C | ||||
| Wireless and CXDI-410C | ||||
| Wireless] | ||||
| Standard Synchronization | ||||
| Mode, Non Generator | ||||
| Connection Mode, | ||||
| Standalone Mode | Standard Synchronization | |||
| Mode, Non Generator | ||||
| Connection Mode | Standard Synchronization Mode, | |||
| Non Generator Connection | ||||
| Mode, Standalone Mode | IDENTICAL |
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. The fundamental scientific technology of the detectors under DIGITAL RADIOGRAPHY CXDI-CS01 have not been modified. The detector units of the DIGITAL RADIOGRAPHY CXDI-CS01 has not been modified, and the change is to update the software in the DIGITAL RADIOGRAPHY CXDI-710C Wireless, CXDI-810C Wireless, and CXDI-410C Wireless; make the Multi Box a standard component; and remove the X-ray I/F Unit as an optional component.
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Image /page/7/Picture/0 description: The image shows the word "Canon" in a bold, red font. The letters are slightly slanted, giving the word a dynamic appearance. The logo is simple and recognizable, representing the well-known electronics and imaging company.
| Documentation was provided demonstrating that the changes to DIGITAL
RADIOGRAPHY CXDI-702C Wireless and CXDI-402C Wireless 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”. |
|---|
| Evaluation of the changes to the DIGITAL RADIOGRAPHY CXDI-CS01 confirmed |
| that the changes did not impact DIGITAL RADIOGRAPHY 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, 62366, 60601-2-54, 62220-1, and 62304. |
| 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 conducted supports a determination of substantial |
| equivalence for the DIGITAL RADIOGRAPHY CXDI-CS01 device. |
| Conclusion: |
| Canon Inc. considers the DIGITAL RADIOGRAPHY CXDI-CS01 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. |