(210 days)
Not Found
No
The summary describes a standard digital radiography detector and its image capture process, with no mention of AI or ML for image processing, analysis, or other functions.
No
The device is described as an "x-ray imager" and is intended for "digital image capture for conventional film/screen radiographic examinations" and "diagnostic procedures," which indicates it is used for imaging and diagnosis, not for treating a condition.
Yes
The "Intended Use / Indications for Use" states that the device "is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures."
No
The device description clearly states it is a solid state x-ray imager with hardware components (detector, scintillator, photo-detectors) that convert x-ray photons into electrical signals. While it includes software for signal conversion and image display, it is fundamentally a hardware device with integrated software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "digital image capture for conventional film/screen radiographic examinations" and "to replace radiographic film/screen systems in all general purpose diagnostic procedures." This describes a device used for in vivo imaging (imaging within a living organism), not for testing samples taken from the body (in vitro).
- Device Description: The description details how the device captures X-ray photons and converts them into digital images. This process is consistent with medical imaging of the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other elements typically associated with in vitro diagnostics.
Therefore, this device falls under the category of medical imaging equipment used for diagnostic purposes directly on the patient, not for in vitro testing.
N/A
Intended Use / Indications for Use
The Digital Radiography CXD1-401C 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.
Product codes (comma separated list FDA assigned to the subject device)
MQB
Device Description
The model of detector included in this submission is a solid state x-ray imager. Model CXDI-401C Wireless has an approximate imaging area of 41.5 x 42.6 cm. For this model, 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. The proposed model includes the Non-Generator Connection Mode, allowing this model to detect x-ray irradiation without direct electrical connection to the x-ray generator.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray
Anatomical Site
Not Found
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 proposed model which demonstrated that the device is safe and effective, performs comparably to the predicate device(s), and is substantially equivalent to to the predicate device(s). 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 devices. Documentation was provided demonstrating compliance of the CXDI-401C 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. Documentation was provided demonstrating that the CXDI-401C Wireless RF technology is in accordance with the FDA Guidance Radio Frequency Wireless Technology in Medical Devices. Documentation was provided demonstrating that the CXDI-401C 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 Non-clinical and Clinical Considerations of the CXD1-701C Wireless compared to the CXD1-401C Wireless, including the image quality evaluation, show the CXDI-401C Wireless to be equivalent to the CXDI-701C Wireless. Testing confirmed that the CXDI-401C 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, 60601-1-3, and 60601-2-32. Testing confirmed that the CXDI-401C Wireless complies with the FCC test standard for SAR. specifically 47CFR 2.1093 and for EMI test regulations FCC Part 15 Subpart B:2012 Class A and ICES-003 Issue 5:2012 Class A. Together, these verification/validation activities successfully demonstrated that the CXDI-401C 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-401C Wireless device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K131106 MQB DIGITAL RADIOGRAPHY CXDI-701C Wireless, Canon, Inc., K103591 MQB DIGITAL RADIOGRAPHY CXDI-401C COMPACT, Canon, Inc.
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
Canon
5. 510(k) SUMMARY
JUL 01 2014
Page 1 of 2
| Submitter: | Canon, Inc. - Medical Equipment Group
30-2 Shimomaruko, 3-chrome
Ohta-ku, Tokyo 146-8501 Japan |
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Applicant:
Mr. Shinji Mori
Manager
TEL: 81-3-3758-2111
FAX: 81-3-5482-3960
mori.shinji@canon.co.jp |
| Date Prepared: | November 22, 2013 (revised Jan 9, 2014) |
| Trade Name: | DIGITAL RADIOGRAPHY CXDI-401C Wireless |
| Common Name: | Flat Panel Digital Imager |
| Classification
Name: | MQB (Solid State X-Ray Imager, Flat Panel/Digital Imager)
892.1680 (Stationary X-Ray System) |
| Predicate Devices: | K131106 MQB DIGITAL RADIOGRAPHY CXDI-701C Wireless, Canon, Inc.
K103591 MQB DIGITAL RADIOGRAPHY CXDI-401C COMPACT, Canon, Inc. |
| Device Description: | The model of detector included in this submission is a solid state x-ray imager.
Model CXDI-401C Wireless has an approximate imaging area of 41.5 x 42.6 cm.
For this model, 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.
The proposed model includes the Non-Generator Connection Mode, allowing this
model to detect x-ray irradiation without direct electrical connection to the x-ray
generator. |
| Statement of
Intended Use: | 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. |
| Summary of
Technological
Characteristics: | Comparisons with the predicate devices show the technological characteristics of
the proposed DIGITAL RADIOGRAPHY CXDI-401C Wireless device to be
substantially equivalent to the predicate devices. The proposed device is
functionally identical to the predicate devices.
The CXDI-401C Wireless is a modification of the CXDI-401C COMPACT cleared
under K103591. The differences between the CXDI-401C Wireless and the CXDI-
401C COMPACT are dynamic range, wireless capability, power supply, and
external dimensions. However, for each of these features where the CXDI-401C
Wireless differs from the CXDI-401C COMPACT, the CXDI-401C Wireless is
identical to the CXDI-701C Wireless. |
1
Image /page/1/Picture/0 description: The image contains the word "Canon" in a bold, sans-serif font. The letters are closely spaced together, creating a compact and recognizable logo. The word is presented in a simple, monochromatic color scheme, with the letters appearing in black against a white background.
K133693
Page 2
Tests
included
5. 510(k) SUMMARY (continued)
risk hazards.
Summary of Technological Characteristics: (continued)
Summary of
Test Data:
Non-Clinical /
The CXDI-401C Wireless utilizes a flat panel detector (Scintillator [Cs]] and amorphous silicon [a-Si]) [identical to both K131106 and K103591] with a pixel pitch of 125x125um [identical to both K131106 and K103591]. 3.320 x 3,408 pixels [identical to K103591], external dimensions of 460 x 15.4mm [equivalent to K103591]. a 16bit dynamic range [identical to K131106], wireless capability fidentical to K131106], an approximate weight of 3.8kg fequivalent to K131106], and has both AC and DC power supply [identical to K131106]. The CXDI-401C Wireless can only be used with systems running Canon CXDI Control NE software.
Tests were performed on the proposed model which demonstrated that the device is safe and effective, performs comparably to the predicate device(s), and is substantially equivalent to to the predicate device(s). 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 devices. Documentation was provided demonstrating compliance of the CXDI-401C 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
Documentation was provided demonstrating that the CXDI-401C Wireless RF technology is in accordance with the FDA Guidance Radio Frequency Wireless Technology in Medical Devices.
traceability of verification/validation tests to software requirements and software
Documentation was provided demonstrating that the CXDI-401C 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 Non-clinical and Clinical Considerations of the CXD1-701C Wireless compared to the CXD1-401C Wireless, including the image quality evaluation, show the CXDI-401C Wireless to be equivalent to the CXDI-701C Wireless.
Testing confirmed that the CXDI-401C 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, 60601-1-3, and 60601-2-32,
Testing confirmed that the CXDI-401C Wireless complies with the FCC test standard for SAR. specifically 47CFR 2.1093 and for EMI test regulations FCC Part 15 Subpart B:2012 Class A and ICES-003 Issue 5:2012 Class A.
Together, these verification/validation activities successfully demonstrated that the CXDI-401C 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-401C Wireless device.
Conclusion:
Canon. Inc. - Medical Equipment Group considers the DIGITAL RADIOGRAPHY CXDI-401C Wireless device to be substantially equivalent to the predicate devices CXDI-401C COMPACT and CXDI-701C Wireless. This conclusion is based on the similarities in primary intended use, principles of operation, functional design, and established medical use.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an abstract eagle or bird-like figure with three curved lines representing wings or feathers.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 1, 2014
Canon. Inc. % Ms. Diane Rutherford Submissions Manager Ken Block Consulting 1201 Richardson Drive, Suite 280 RICHARDSON TX 75080
Re: K133693
Trade/Device Name: Digital Radiography CXDI-401C Wireless Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: May 23, 2014 Received: May 29, 2014
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 10 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: CDRFI docs 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 or any I vith 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.
3
Page 2 - Ms. Diane Rutherford
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/ResourcesforYou/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 vours.
Sammy H. Menge
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
4
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) K133693
Device Name
Digital Radiography CXDI-401C Wireless
Indications for Use (Describe)
The Digital Radiography CXD1-401C 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.
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)
Stenngh. Menge
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 The burden time for this onloolion of maintains to uces, gather and maintain the data needed and complete time to review that dolled of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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FORM FDA 3881 (1/14)