(200 days)
Not Found
No
The document describes a digital radiography detector and its features, focusing on hardware improvements, image capture, and basic signal processing. There is no mention of AI, ML, or advanced image analysis beyond standard digital conversion and display.
No.
The device is described as an X-ray imager intended for capturing and displaying radiographic images for diagnostic purposes, not for treating any medical condition.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is intended "to replace radiographic film/screen systems in all general purpose diagnostic procedures."
No
The device description clearly details a physical hardware component, a solid state x-ray imager (flat panel detector), which is the primary medical device. While it includes software for image processing and communication, it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that the device is a "digital image capture for conventional film/screen radiographic examinations." It captures radiographic images of human anatomy using X-rays.
- Lack of Biological Sample Analysis: There is no mention of the device analyzing biological samples or performing any tests on materials taken from the body. Its function is solely focused on capturing and displaying images generated by X-ray radiation passing through the body.
Therefore, the CXDI-410C Wireless falls under the category of a medical imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The 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.
Product codes (comma separated list FDA assigned to the subject device)
MQB
Device Description
The CXDI-410C Wireless is a solid state x-ray imager with an approximate imaging area of 42.6 x 41.5 cm. The detector intercepts x-ray photons and the scintillator emits visible spectrum photons that illuminate an array of photo-detectors that create electrical signals. After the electrical signals are generated, the signals are converted to digital values and the images will be displayed on monitors. The digital value can be communicated to the operator console via wiring connection or wireless.
For the proposed model, temporary image storage is now possible and the detector weigh has been reduced from that of the predicate. The proposed model has increased protection against ingress, and continues to include the Standard Synchronization Mode, Non-Generator Connection Mode (detection of x-ray irradiation without direct electrical connection to the x-ray generator), and is compatible with the Scatter Correction feature. Testing has been conducted and has demonstrated that these changes have no impact on the safety or effectiveness of this flat panel detector.
The Standalone Mode allows for examinations using only the detector and a mobile X-ray system without a control computer by utilizing the temporary image storage on the FPD. The CXDI-410C Wireless can be used in emergency/trauma situations and other environments where equipment other than the detector and mobile X-ray system cannot be used and/or wireless communication is not possible.
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)
Tests were performed on the device which demonstrated that the device is safe and effective, performs comparably to the predicate device, and is substantially equivalent to the predicate device. Tests included verification/validation testing to internal functional specifications (including software) and non-clinical image comparisons involving flat panel display static and dynamic images taken with the new device and the predicate device. Documentation was provided demonstrating compliance of the CXDI-410C Wireless to all FDA requirements stated in Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, 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-410C 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-410C Wireless, compared to the predicate, show the CXDI-410C Wireless to be equivalent to the predicate.
Testing confirmed that the CXDI-410C 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, 60601-1-2, 60601-1-6, and 60601-2-54.
Together, these verification/validation activities successfully demonstrated that the CXDI-410C 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. Therefore, the verification/validation testing conducted supports a determination of substantial equivalence for the CXDI-410C Wireless 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.
Not Found
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
November 17, 2017
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and 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. - Medical Equipment Group % Ms. Diane Rutherford Submissions Manager Ken Block Consulting 1201 Richardson Drive, Suite 160 RICHARDSON TX 75080
Re: K171270
Trade/Device Name: DIGITAL RADIOGRAPHY CXDI-410C Wireless Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: October 26, 2017 Received: October 27, 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Robert Ocks
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name DIGITAL RADIOGRAPHY CXDI-410C Wireless
Indications for Use (Describe)
The 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.
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)
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
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)
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
5. 510(k) SUMMARY
| Submitter: | Canon, Inc. - Medical Equipment Group
9-1, Imaikami-cho, Nakahara-ku
Kawasaki, Kanagawa 211-8501 Japan |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Canon, Inc. - Medical Equipment Group
Mr. Shinji Mori
Manager
9-1, Imaikami-cho, Nakahara-ku
Kawasaki, Kanagawa 211-8501, Japan
TEL: 81-3-3758-2111
FAX: 81-44-739-6493
mori.shinji@canon.co.jp |
| Date Prepared: | April 26, 2017 |
| Proposed Device | Manufacturer: Canon, Inc. - Medical Equipment Group
Trade Name: DIGITAL RADIOGRAPHY CXDI-410C Wireless
Common Name: Solid State X-Ray Imager (Flat Panel/Digital Imager)
Classification Name: Stationary X-ray system
Product Code / MQB
Regulatory Standard: 892.1680, Stationary X-ray System |
| Predicate Device: | Clearance: K133693 dated July 01, 2014
Manufacturer: Canon, Inc. - Medical Equipment Group
Trade Name: DIGITAL RADIOGRAPHY CXDI-401C Wireless
Common Name: Solid State X-Ray Imager (Flat Panel/Digital Imager)
Classification Name: Stationary X-ray system
Product Code / MQB
Regulatory Standard: 892.1680, Stationary X-ray System |
| Device
Description: | The CXDI-410C Wireless is a solid state x-ray imager with an approximate imaging
area of 42.6 x 41.5 cm. The detector intercepts x-ray photons and the scintillator emits
visible spectrum photons that illuminate an array of photo-detectors that create electrical
signals. After the electrical signals are generated, the signals are converted to digital
values and the images will be displayed on monitors. The digital value can be
communicated to the operator console via wiring connection or wireless.
For the proposed model, temporary image storage is now possible and the detector
weigh has been reduced from that of the predicate. The proposed model has increased
protection against ingress, and continues to include the Standard Synchronization Mode,
Non-Generator Connection Mode (detection of x-ray irradiation without direct electrical
connection to the x-ray generator), and is compatible with the Scatter Correction feature.
Testing has been conducted and has demonstrated that these changes have no impact on
the safety or effectiveness of this flat panel detector.
The Standalone Mode allows for examinations using only the detector and a mobile X-
ray system without a control computer by utilizing the temporary image storage on the
FPD. The CXDI-410C Wireless can be used in emergency/trauma situations and other
environments where equipment other than the detector and mobile X-ray system cannot
be used and/or wireless communication is not possible. |
4
The weight of the CXDI-410C (2.8kg) is effectively 25% less than the weight of the predicate CXDI-401C (3.8kg.) The weight reduction was accomplished through material changes, changes in the structure, and downsized components such as electrical boards and batteries.
The proposed device CXDI-410C offers an optional docking station. This option allows for a simplified method for charging the internal battery of the proposed CXDI-410C. The Docking Station connects to the PC with an Ethernet cable (cannot communicate wirelessly.) By placing a FPD into the docking station, that FPD is "registered" and available for use.
The DIGITAL RADIOGRAPHY CXDI-410C Wireless provides digital image capture Statement of Intended Use: for conventional film/screen radiographic examinations. This device is intended to capture for display radiographic images of human anatomy, and to replace radiographic film/screen systems in all general purpose diagnostic procedures. This device is not intended for mammography applications.
Summary of Comparisons with the predicate device show the technological characteristics of the Technological proposed DIGITAL RADIOGRAPHY CXDI-410C Wireless device to be substantially Characteristics: equivalent to the predicate device. The proposed device is functionally identical to the predicate device.
The major difference between the proposed and predicate devices is that the proposed device has 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 device.
| | New Device: K17
CXDI-410C Wireless | Predicate Device: K133693
CXDI-401C Wireless |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for Use | The 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. | The DIGITAL RADIOGRAPHY CXDI-401C
Wireless provides digital image capture
for conventional film/screen radiographic
examinations. This device is intended to
replace radiographic film/screen systems
in all general purpose diagnostic
procedures. This device is not intended
for mammography applications. |
| Application | General Radiography | General Radiography |
| Scintillator | CsI(TI)
[Cesium lodide doped with Thallium] | CsI(TI)
[Cesium lodide doped with Thallium] |
| Pixel Pitch | 125 μm | 125μm |
| Pixels | 3,408 x 3,320 (≈ 11.3 mil) | 3,408 x 3,320 (≈ 11.3 mil) |
| External
Dimensions | 460 x 460 x 15.7 mm | 460 x 460 x 15.4 mm |
| Weight | ≈ 2.8 kg | ≈ 3.8 kg |
| DQE | 0.6 | 0.6 |
| Spatial Resolution | 35% [MTF@2lp/mm] | 35% [MTF@2lp/mm] |
| Control SW | CXDI Control Software
Added Standalone function | CXDI Control Software |
| Device FW | PCA-FE-710
Added Standalone function
Added wireless channels with DFS and
TPC functions | PCA-FE-701 |
5
| Communication between Detector and: | Communication between Detector and: | |
|---|---|---|
| Wireless Functions | Multi Box | X-ray I/F Unit |
| Control PC | 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.
Tests were performed on the device which demonstrated that the device is safe and Summary of Non-Clinical / effective, performs comparably to the predicate device, and is substantially equivalent to Test Data: the predicate device. Tests included verification/validation testing to internal functional specifications (including software) and non-clinical image comparisons involving flat panel display static and dynamic images taken with the new device and the predicate device. Documentation was provided demonstrating compliance of the CXDI-410C Wireless to all FDA requirements stated in Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, 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-410C 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-410C Wireless, compared to the predicate, show the CXDI-410C Wireless to be equivalent to the predicate.
Testing confirmed that the CXDI-410C 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, 60601-1-2, 60601-1-6, and 60601-2-54.
Together, these verification/validation activities successfully demonstrated that the CXDI-410C 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. Therefore, the verification/validation testing conducted supports a determination of substantial equivalence for the CXDI-410C Wireless device.
- Conclusion: Canon, Inc. – Medical Equipment Group considers the DIGITAL RADIOGRAPHY CXDI-410C Wireless device to be substantially equivalent to the predicate device listed above. This conclusion is based on the similarities in primary intended use, principles of operation, functional design, and established medical use.