DIGITAL RADIOGRAPHY CXDI-710C WIRELESS, DIGITAL RADIOGRAPHY CXDI-810C WIRELESS
Device Facts
| Record ID | K170332 |
|---|---|
| Device Name | DIGITAL RADIOGRAPHY CXDI-710C WIRELESS, DIGITAL RADIOGRAPHY CXDI-810C WIRELESS |
| Applicant | Canon, Inc. |
| Product Code | MQB · Radiology |
| Decision Date | Mar 1, 2017 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1680 |
| Device Class | Class 2 |
Indications for Use
The DIGITAL RADIOGRAPHY CXDI-710C Wireless and CXDI-810C 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.
Device Story
Solid state X-ray detectors (CXDI-710C/810C) capture X-ray photons using a CsI(Tl) scintillator; converts photons to visible light; light illuminates photo-detector array to generate electrical signals; signals converted to digital values. Used in general radiography; operated by clinicians. Features wireless or wired communication to control console; includes internal nonvolatile memory for temporary image storage; supports Non-Generator Connection Mode (detects irradiation without direct electrical connection). Reduced weight compared to predicates; improved ingress protection. Output displayed on monitors for diagnostic review by healthcare providers to inform clinical decision-making.
Clinical Evidence
Bench testing only. Included verification/validation testing to internal functional specifications, software validation (moderate Level of Concern), and non-clinical image comparisons between subject and predicate devices. Compliance demonstrated with IEC 60601-1, 60601-1-6, and 60601-2-54 standards.
Technological Characteristics
Solid state X-ray imager; CsI(Tl) scintillator; 125 µm pixel pitch. Wireless/wired connectivity; internal nonvolatile memory. Dimensions: 710C (384x460x15.7 mm), 810C (307.5x384x15.7 mm). Software: CXDI Control Software. Standards: IEC 60601-1, 60601-1-6, 60601-2-54.
Indications for Use
Indicated for digital image capture for conventional film/screen radiographic examinations of human anatomy in general purpose diagnostic procedures. Not for mammography.
Regulatory Classification
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.
Special Controls
*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.
Predicate Devices
Submission Summary (Full Text)
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 1, 2017
Canon, Inc. % Ms. Diane Rutherford Submissions Manager Ken Block Consulting 1201 Richardson Drive, Suite 160 RICHARDSON TX 75080
Re: K170332
Trade/Device Name: Digital Radiography CXDI-710C Wireless Digital Radiography CXDI-810C Wireless Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MOB Dated: January 6, 2017 Received: February 2, 2017
Dear Ms. Rutherford:
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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Michael D'Hara
For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
## Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
K170332
Device Name DIGITAL RADIOGRAPHY CXDI-710C Wireless DIGITAL RADIOGRAPHY CXDI-810C Wireless
#### Indications for Use (Describe)
The DIGITAL RADIOGRAPHY CXDI-710C Wireless and CXDI-810C Wireless provides digital image capture for conventional film/screen radiographic examinations. This device is intended to capture, for display, radiographic images of human anatomy, and to replace radiographic film/screen systems in all general purpose diagnostic procedures. This device is not intended for mammography applications.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
#### FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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# 5. 510(k) SUMMARY
| Submitter: | Canon, Inc. - Medical Equipment Group<br>9-1, Imaikami-cho, Nakahara-ku<br>Kawasaki, Kanagawa 211-8501 Japan | |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mr. Shinji Mori<br>Manager<br>TEL: 81-3-3758-2111<br>FAX: 81-44-739-6493<br>mori.shinji@canon.co.jp | |
| Date Prepared: | January 26, 2017 | |
| Proposed Device | Manufacturer:<br>Trade Name:<br>Common Name:<br>Classification Name:<br>Product Code /<br>Regulatory Standard: | Canon<br>DIGITAL RADIOGRAPHY CXDI-710C Wireless<br>DIGITAL RADIOGRAPHY CXDI-810C Wireless<br>Solid State X-ray Imager<br>Stationary X-ray system<br>MQB<br>892.1680 Stationary X-ray System |
| Predicate Device: | Clearance:<br>Manufacturer:<br>Trade Name:<br>Common Name:<br>Classification Name:<br>Product Code /<br>Regulatory Standard: | K131106 dated July 03, 2013<br>Canon<br>DIGITAL RADIOGRAPHY CXDI-701C Wireless<br>DIGITAL RADIOGRAPHY CXDI-801C Wireless<br>Solid State X-ray Imager<br>Stationary X-ray system<br>MQB<br>892.1680 Stationary X-ray System |
| Device Description: | The two models of detectors included in this submission are solid state x-ray imagers.<br>Model CXDI-710C Wireless has an approximate imaging area of 35.0 x 42.6 cm,<br>while model CXDI-810C Wireless has an approximate imaging area of 35.0 x 27.4 cm.<br><br>For both models, the detector intercepts x-ray photons and the scintillator emits<br>visible spectrum photons that illuminate an array of photo-detectors that create<br>electrical signals. After the electrical signals are generated, the signals are converted<br>to digital values and the images will be displayed on monitors. The digital value can<br>be communicated to the operator console via wiring connection or wireless.<br><br>For the proposed models, temporary image storage is now possible and the detector<br>weight has been reduced from that of the predicates. The proposed models have<br>increased protection against ingress, continue to include the Non-Generator<br>Connection Mode (detection of x-ray irradiation without direct electrical connection<br>to the x-ray generator) and are compatible with the Scatter Correction feature. | |
| Indications for Use: | The DIGITAL RADIOGRAPHY CXDI-710C Wireless and CXDI-810C Wireless<br>provide digital image capture for conventional film/screen radiographic<br>examinations. These devices are intended to capture, for display, radiographic images<br>of human anatomy, and to replace radiographic film/screen systems in all general<br>purpose diagnostic procedures. These devices are not intended for mammography<br>applications. | |
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## 5. 510(k) SUMMARY (continued)
Summary of Technological Characteristics: Comparisons with the predicate devices show the technological characteristics of the proposed DIGITAL RADIOGRAPHY CXDI-710C Wireless and DIGITAL RADIOGRAPHY CXDI-810C Wireless devices to be substantially equivalent to the predicate devices. The proposed devices are functionally identical to the predicate devices.
The major difference between the proposed and predicate devices is that the proposed devices have a reduction in weight and can save captured in an internal nonvolatile memory of the detector. No other technological changes have been made to the proposed devices.
| | New Devices: K170332<br>CXDI-710C / 810C Wireless | Predicate Device: K131106<br>CXDI-701C / 801C Wireless |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for Use | The DIGITAL RADIOGRAPHY CXDI-710C<br>Wireless and CXDI-810C Wireless provides<br>digital image capture for conventional<br>film/screen radiographic examinations.<br>This device is intended to capture, for<br>display, radiographic images of human<br>anatomy, and to replace radiographic<br>film/screen systems in all general purpose<br>diagnostic procedures. This device is not<br>intended for mammography applications. | The DIGITAL RADIOGRAPHY CXDI-701G<br>Wireless, CXDI-701C Wireless, CXDI-801G<br>Wireless and CXDI-801C Wireless provide<br>digital image capture for conventional<br>film/screen radiographic examinations.<br>These devices are intended to replace<br>radiographic film/screen systems in all<br>general purpose diagnostic procedures.<br>These devices are not intended for<br>mammography applications. |
| Application | General Radiography | General Radiography |
| Scintillator | CsI(TI)<br>[Cesium lodide doped with Thallium] | CsI(TI)<br>[Cesium lodide doped with Thallium] |
| Pixel Pitch | 125 µm | 125µm |
| Pixels | 710C: 2,800 x 3,408 (~ 9.5 mil)<br>810C: 2,800 x 2,192 (~ 6.1 mil) | 701C: 2,800 x 3,408 (~ 9.5 mil)<br>801C: 2,192 x 2,800 (~ 6.1 mil) |
| External<br>Dimensions | 710C: 384 x 460 x 15.7 mm<br>810C: 307.5 x 384 x 15.7 mm | 701C: 384 x 460 x 15 mm<br>801C: 307 x 384 x 15 mm |
| Weight | 710C: 2.3 kg<br>810C: 1.8 kg | 701C: 3.3 kg<br>801C: 2.3 kg |
| Spatial Resolution | 35% [MTF@2lp/mm] | 35% [MTF@2lp/mm] |
| Control SW | CXDI Control Software<br>Added Standalone function | CXDI Control Software |
| Device FW | PCA-FE-710<br>Added Standalone function<br>Added wireless channels with DFS and<br>TPC functions | PCA-FE-701 |
| Wireless Functions | Communication between Detector and:<br>Multi Box<br>Control PC | Communication between Detector and:<br>X-ray I/F Unit<br>Control PC |
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.
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Summary of Non-Clinical / Test Data:
Tests were performed on the models which demonstrated that the device is safe and effective, performs comparably to the predicate device(s), and is substantially equivalent to the predicate device(s). Tests included verification/validation testing to internal functional specifications (including software) and non-clinical image comparisons involving flat panel display images taken with the new device and the predicate device(s). Documentation was provided demonstrating compliance of the CXDI-710C Wireless and CXDI-810C Wireless to all FDA requirements stated in Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices for a moderate LOC, including results of verification/validation plus traceability of verification/validation tests to software requirements and software risk hazards. Other FDA guidance documents used in development include Radio Frequency Wireless Technology in Medical Devices and Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.
Documentation was provided demonstrating that the CXDI-710C / 810C Wireless complies with the FDA requirements stated in Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices. The evaluations of the CXDI-710C / 810C Wireless compared to the CXDI-701C / 801C Wireless, show the CXDI-710C / 810C Wireless to be equivalent to the CXDI-701C / 801C Wireless.
Testing confirmed that the CXDI-710C Wireless and CXDI-810C Wireless complies 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. 60601-1-6, and 60601-2-54.
Together, these verification/validation activities successfully demonstrated that the CXDI-710C Wireless and CXDI-810C Wireless correctly performs as designed, has been validated for its intended use, and raises no new questions regarding either safety or effectiveness when compared to the predicate device(s). Therefore, the verification/validation_testing_conducted_supports_a_determination_of_substantial equivalence for the CXDI-710C Wireless and CXDI-810C Wireless device.
Conclusion: Canon, Inc. – Medical Equipment Group considers the DIGITAL RADIOGRAPHY CXDI-710C Wireless and DIGITAL RADIOGRAPHY CXDI-810C Wireless devices to be substantially equivalent to the predicate devices listed above. This conclusion is based on the similarities in primary intended use, principles of operation, functional design, and established medical use.
