(23 days)
No
The summary describes a flat panel detector for converting X-ray images to digital signals and does not mention any AI or ML capabilities.
No
The device is described as a flat panel detector used for diagnostic imaging, not for treating any medical conditions.
Yes
The device is designed to provide images "during diagnostic, surgical and interventional procedures," and its applications include "angiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical-care and emergency room procedures," all of which are frequently diagnostic in nature. While it does not perform the diagnosis itself, it provides the images used by physicians for diagnostic purposes.
No
The device description explicitly states it is a "digital radiography flat panel detector" and a "component of an x-ray system," indicating it is a hardware device that converts X-rays into digital signals.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The Canon CSX-20 is a flat panel detector that captures X-ray images of the human anatomy directly during procedures. It works by converting X-rays into digital signals. This is an in vivo (within the living body) imaging process.
- Intended Use: The intended use clearly describes imaging procedures performed on the patient's body, not testing of specimens taken from the body.
Therefore, the function and intended use of the Canon CSX-20 align with medical imaging devices used in vivo, not with in vitro diagnostic devices.
N/A
Intended Use / Indications for Use
The flat panel detector CSX-20 is designed to provide fluoroscopic and spot radiographic images of human anatomy during diagnostic, surgical and interventional procedures. Examples of clinical application may include angiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical-care and emergency room procedures or other-imaging applications at the physician's discretion. The device is intended to replace the spot-film devices. The device is also intended to replace fluoroscopic images obtained through image intensifier technology. Not intended for mammography applications.
Product codes
OWB, JAA
Device Description
The Canon CSX-20 is a digital radiography flat panel detector that can take fluoroscopic and spot radiographic images of any part of the body. It directly converts the X-ray images captured by the sensor into high-resolution digital images. The instrument is a component of an x-ray system and as such cannot be used outside of such a system. This unit converts the X-rays into digital signals. Not intended for mammography applications.
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
physician's discretion
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 and is substantially equivalent to the predicate device. Tests include: Performance testing and Software Validation. Electrical safety and Electromagnetic Compatibility testing has been performed. The unit complies with the US Performance Standard for radiographic equipment.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K111824 Canon CSX-10
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. 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). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic 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. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device 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
JUN - 7 2012
K1214444
.
| 5. 510(k) SUMMARY | JUN - 7 20 | |
|---|---|---|
| Submitter: | Canon, Inc. - Medical Equipment Group | |
| 30-2 Shimomaruko, 3-chrome | ||
| Ohta-ku, Tokyo 146-8501 Japan | ||
| Contact Person: | Mr. Naoyasu Asaka | |
| Staff Manager | ||
| TEL: 81-3-3758-2111 | ||
| FAX: 81-3-5482-3960 | ||
| asaka.naoyasu@canon.co.jp | ||
| Date Prepared: | April 24, 2012 (Revised June 7, 2012) | |
| Trade Name: | CSX-20 Flat Panel Detector | |
| Common Name: | Solid State X-Ray Imager (Flat Panel/Digital Imager) | |
| Classification Name: | OWB, JAA 892.1650 Image-intensified fluoroscopic x-ray system | |
| Predicate Device: | K111824 Canon CSX-10 (MQB 892.1650) | |
| Device Description: | The Canon CSX-20 is a digital radiography flat panel detector that can take | |
| fluoroscopic and spot radiographic images of any part of the body. It directly | ||
| converts the X-ray images captured by the sensor into high-resolution digital | ||
| images. The instrument is a component of an x-ray system and as such cannot be | ||
| used outside of such a system. This unit converts the X-rays into digital signals. Not | ||
| intended for mammography applications. | ||
| Statement of | ||
| Intended Use: | The flat panel detector CSX-20 is designed to provide fluoroscopic and spot | |
| radiographic images of human anatomy during diagnostic, surgical and | ||
| interventional procedures. Examples of clinical application may include | ||
| angiography, endoscopy, urologic, orthopedic, neurologic; vascular, cardiac, | ||
| critical-care and emergency room procedures or other imaging applications at the | ||
| physician's discretion. The device is intended to replace spot-film devices. The | ||
| device is also intended to replace fluoroscopic images obtained through image | ||
| intensifier technology. Not intended for mammography applications. | ||
| Summary of | ||
| Technological | ||
| Characteristics: | Comparison with the predicate shows the technological characteristics of the | |
| CSX-20 are substantially equivalent to the predicate device. The flat panel detector | ||
| units are functionally identical. | ||
| The A/D Conversion was modified from 14-bit precision to 16-bit precision to | ||
| improve the resolution and S/N. This modification allows for improved tonal | ||
| precision. | ||
| Grayscale is a function of the A/D conversion. As a result of the A/D conversion | ||
| modification, the grayscale gradations have quadrupled from the 4096 of the CSX- | ||
| 10 to the 16384 gradations now available with the CSX-20. | ||
| By modifying the A/D conversion to 16-bits, a maximum frame rate of the 240 fps | ||
| has been improved. | ||
| The modifications described above are all related to the change in A/D conversion | ||
| from 14-bit to 16-bit precision. These modifications have been incorporated into the | ||
| CSX-20 in an effort to improve the product performance. |
. . . . .
1
Canon
Summary of Non-Clinical /Test Data:
Tests were performed on the device which demonstrated that the device is safe and effective, performs comparably to and is substantially equivalent to the predicate device. Tests include: Performance testing and Software Validation. Electrical safety and Electromagnetic Compatibility testing has been performed. The unit complies with the US Performance Standard for radiographic equipment. .
Conclusion:
Canon, Inc. - Medical Equipment Group considers the CSX-20 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 for the flat panel detector.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
JUN - 7 2012
Canon, Inc. - Medical Equipment Group % Ms. Diane Rutherford Regulatory Engineer Ken Block Consulting 1201 Richardson Drive, Suite 280 RICHARDSON TX 75080
Re: K121444
Trade/Device Name: CSX-20 Flat Panel Detector Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB and JAA Dated: April 24, 2012 Received: May 15, 2012
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.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
3
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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/cdrh/industry/support/index.html.
Sincerely Yours,
Janine M. Morris
Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE
510(k) Number:
Device Name: CSX-20 Flat Panel Detector
Indications for Use:
The flat panel detector CSX-20 is designed to provide fluoroscopic and spot radiographic images of human anatomy during diagnostic, surgical and interventional procedures. Examples of clinical application may include angiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical-care and emergency room procedures or other-imaging applications at the physician's discretion. The device is intended to replace the spot-film devices. The device is also intended to replace fluoroscopic images obtained through image intensifier technology. Not intended for mammography applications.
Prescription Use _ X (21 CFR 801 Subpart D)
Over-the-Counter Use AND/OR (21. CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDHR, Office of Device Evaluation (ODE)
Jahmal DD
(Division Sign-Off)
(Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510KLA21444
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