(75 days)
Not Found
No
The description focuses on hardware components, signal processing, and image acquisition methods, with no mention of AI or ML algorithms for image analysis, interpretation, or other functions.
No.
Explanation: The device is described as a digital radiography system intended for diagnostic procedures, which captures images for examination, rather than providing therapy.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is for "all general purpose diagnostic procedures."
No
The device description clearly details hardware components (solid state x-ray imagers, photo-detectors, scintillator) that are integral to the device's function of capturing and converting x-ray photons into digital signals. While software is mentioned as part of the verification/validation testing, the core of the device is hardware.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "digital image capture for conventional film/screen radiographic examinations" and is intended to "replace radiographic film/screen systems in all general purpose diagnostic procedures". This describes an imaging device used in vivo (on a living patient) to capture images of the internal body structure.
- Device Description: The description details how the device intercepts x-ray photons and converts them into digital images. This process is consistent with medical imaging equipment used on patients.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, or 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 device described is a medical imaging device used for diagnostic radiography, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The DIGITAL RADIOGRAPHY CXDI-701G Wireless, CXDI-701C Wireless, CXDI-801G Wireless and CXDI-801C Wireless provide digital image capture for conventional film/screen radiographic examinations. These devices are intended to replace radiographic film/screen systems in all general purpose diagnostic procedures. These devices are not intended for mammography applications.
Product codes (comma separated list FDA assigned to the subject device)
MQB
Device Description
The four models of detectors included in this submission are solid state x-ray imagers. Models CXDI-701C Wireless and CXDI-701G Wireless have an approximate imaging area of 35.0 x 42.6 cm, while models CXDI-801C Wireless and CXDI-801G Wireless have an approximate imaging arca of 35.0 x 27.4 cm For all models, 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 all four of the proposed models, the dynamic range has been increased to allow for improved tonal precision. In addition, these models can detect x-ray irradiation without direct electrical connection to the x-rav generator. referred to as the Non-Generator Connection Mode. The x-ray flat panel detector integrates a real-time x-ray irradiation sensor as well as an imaging detector on the same detector surface. During the Non-Generator Connection Mode. the irradiation sensor is activated to detect the start of irradiation while the imaging detector is in the idling status. The detection of irradiation shifts the imaging detector to the image acquisition status instantaneously to obtain the x-ray image.
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
Tests were performed on the four models which demonstrated that the device is safe and effective, performs comparably to the predicate device(s), and is equivalent to the predicate device(s). Tests included substantially 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-701G Wireless. CXDI-701C Wireless, CXDI-801G Wireless and CXDI-801C Wireless to all FDA requirements stated in Guidance for the Content of Premarket Submissions for Software Contained in in Medical Devices. including results of verification/validation plus traceability of verification/validation tests 10 software requirements and software risk hazards.
Testing confirmed that the CXDI-701G Wireless, CXDI-701C Wireless, CXDI-801G Wireless and CXDI-801C 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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Together, these verification activities successfully demonstrated that the CXDI-701G Wireless, CXDI-701C Wireless, CXDI-801G Wireless and CXDI-801C Wireless correctly performs as designed, has been validated for its intended use, and raises no new questions regarding cither 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-701G Wireless, CXDI-701C Wireless, CXDI-801G · Wireless and CXD1-801C 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.
K102012 MQB CXD1-70C Wireless, K112309 MQB DIGITAL RADIOGRAPHY CXDI-80C Wireless, DIGITAL RADIOGRAPHY CXDI-80G Wireless.
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
Canon
**K131106**Page 1 of 3
5. 510(k) SUMMARY
| 5. 510(k) SUMMARY | |
|---|---|
| Submitter: | Canon, Inc. - Medical Equipment Group |
| 30-2 Shimomaruko. 3-chrome | |
| Ohta-ku, Tokyo 146-8501 Japan | |
| JUL 0 3 2013 | |
| Contact Person: | Mr. Shinji Mori |
| Manager | |
| TEL: 81-3-3758-2111; | |
| FAX: 81-3-5482-3960 | |
| mori.shinji@canon.co.jp | |
| Date Prepared: | April 15, 2013 revised June 20, 2013 |
| Trade Name: | DIGITAL RADIOGRAPHY CXDI-701C Wireless |
| DIGITAL RADIOGRAPHY CXD1-701G Wireless | |
| DIGITAL RADIOGRAPHY CXD1-801C Wireless | |
| DIGITAL RADIOGRAPHY CXDI-801G Wireless | |
| Common Name: | Image Intensified Fluoroscopic X-Ray System |
| Classification | |
| Name: | Solid State X-Ray Imager (Flat Panel/Digital Imager) |
| MQB 892.1650 | |
| Predicate Devices: | K102012 MQB CXD1-70C Wireless, Canon, Inc. |
| K112309 MQB DIGITAL RADIOGRAPHY CXDI-80C Wireless, Canon, Inc. | |
| DIGITAL RADIOGRAPHY CXDI-80G Wireless. Canon. Inc. | |
| Device Description: | The four models of detectors included in this submission are solid state x-ray |
| imagers. Models CXDI-701C Wireless and CXDI-701G Wireless have an | |
| approximate imaging area of 35.0 x 42.6 cm, while models CXDI-801C | |
| Wireless and CXDI-801G Wireless have an approximate imaging arca of 35.0 x | |
| 27.4 cm | |
| For all models, 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 all four of the proposed models, the dynamic range has been increased to | |
| allow for improved tonal precision. In addition, these models can detect x-ray | |
| irradiation without direct electrical connection to the x-rav generator. referred to | |
| as the Non-Generator Connection Mode. The x-ray flat panel detector integrates | |
| a real-time x-ray irradiation sensor as well as an imaging detector on the same | |
| detector surface. During the Non-Generator Connection Mode. the irradiation | |
| sensor is activated to detect the start of irradiation while the imaging detector is | |
| in the idling status. The detection of irradiation shifts the imaging detector to the | |
| image acquisition status instantaneously to obtain the x-ray image. | |
:
1
Image /page/1/Picture/0 description: The image shows the word "Canon" in a bold, sans-serif font. The letters are black, and the background is white. The word is slightly distorted, as if it were printed on a textured surface.
K131106
Page 2 of 3
5. 510(k) SUMMARY (continued)
Statement of Intended Use:
The DIGITAL RADIOGRAPHY CXD1-701G Wireless, CXD1-701C Wireless, CXDI-801G Wireless and CXDI-801C Wireless provide digital image capture for conventional film/screen radiographic examinations. These devices are intended to replace radiographic film/screen systems in all general purpose diagnostic procedures. These devices are not intended for mammography applications.
Summary of Technological Characteristics: Comparisons with the predicate devices show the technological characteristics of the proposed DIGITAL RADIOGRAPHY CXDI-701C Wireless, DIGITAL RADIOGRAPHY CXDI-701G Wireless. DIGITAL RADIOGRAPHY CXDI-801C Wireless, and DIGITAL RADIOGRAPHY CXDI-801G Wireless devices to be substantially equivalent to the predicate devices. The proposed devices are functionally identical to the predicate devices.
An additional change for the 701C/G and 801C/G models is that these models can detect x-ray irradiation without direct electrical connection to the x-ray generator, referred to as the Non-Generator Connection Mode. The x-ray flat panel detector integrates a real-time x-ray irradiation sensor as well as an imaging detector on the same detector surface. During the Non-Generator Connection Mode, the irradiation sensor is activated to detect the start of irradiation while the imaging detector is in the idling status. The detection of irradiation shifts the imaging detector to the image acquisition status instantaneously to obtain the x-ray image.
The dynamic range has been increased from the previously cleared values of approximately 4 digit with 14-bit Linear A/D and 12-bit Output Data, to the new values of approximately 4 digit with 16-bit Linear A/D and 16-bit Output Data. This modification allows for improved tonal precision and product performance.
Tests were performed on the four models which demonstrated that the device is safe and effective, performs comparably to the predicate device(s), and is equivalent to the predicate device(s). Tests included substantially 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-701G Wireless. CXDI-701C Wireless, CXDI-801G Wireless and CXDI-801C Wireless to all FDA requirements stated in Guidance for the Content of Premarket Submissions for Software Contained in in Medical Devices. including results of verification/validation plus traceability of verification/validation tests 10 software requirements and software risk hazards.
Testing confirmed that the CXDI-701G Wireless, CXDI-701C Wireless, CXDI-801G Wireless and CXDI-801C 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.
Summarv of Non-Clinical / Test Data:
2
Image /page/2/Picture/0 description: The image shows the word "Canon" in a bold, sans-serif font. The letters are black against a white background. The word is slightly distorted, with some of the letters appearing slightly blurred.
K131106
Page 3 of 3
5. 510(k) SUMMARY (continued)
Summary of Non-Clinical / Test Data: (continued)
Together, these verification activities successfully demonstrated that the CXDI-701G Wireless, CXDI-701C Wireless, CXDI-801G Wireless and CXDI-801C Wireless correctly performs as designed, has been validated for its intended use, and raises no new questions regarding cither 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-701G Wireless, CXDI-701C Wireless, CXDI-801G · Wireless and CXD1-801C Wireless device.
Conclusion:
Canon. Inc. - Medical Equipment Group considers the DIGITAL RADIOGRAPHY CXDI-701C Wireless, DIGITAL RADIOGRAPHY CXDI-701G Wireless. DIGITAL RADIOGRAPHY CXDI-801C Wireless, and DIGITAL RADIOGRAPHY CXDI-801G 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.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/13 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the bird-like figure. The logo is black and white.
Public Health Service
Food and Drug Administration · [0903 New Hampshire Avenue Document Contral Center - WO66-G609 Silver Spring, MD 20993-0002
July 3, 2013
Canon. Inc % Ms. Diane Rutherford Submissions Manager Ken Block Consulting 1201 Richardson Drive, Suite 280 RICHARDSON TX 75080
Re: K131106
Trade/Device Name: Digital Radiography CXDI-701C/G, CXDI-801C/G Wireless Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MOB Dated: April 15. 2013
Received: April 19, 2013
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. Insting 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
4
Page 2- Ms. Rutherford
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance 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,
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
5
510(k) Number: K131106
Device Name: DIGITAL RADIOGRAPHY CXDI-701C Wirelexs, DIGITAL RADIOGRAPHY Wireless, DIGITAL RADIOGRAPHY CCXDI-801C' Wireless, CXDI-701G DIGITAL RADIOGRAPHY CXDI-801G Wireless
Indications for Use:
The DIGITAL RADIOGRAPHY CXDI-701G Wireless, CXDI-701C Wireless, CXDI-801G Wireless and CXDI-801C Wireless provide digital image capture for conventional film!screen rudiographic examinations. These devices are intended to replace radiographic film!screen systems in all general purpose diagnostic procedures are not intended for mammography applications.
Prescription Use X (Part 21 CFR 801 Subpart D)
210(k)
AND/OR
Over-the-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDHR. Office of In Vitro Diagnostics and Radiological Health (OIR)
Javier M. Menage.
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
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Section 4: Page 1 of 1