← Product Code [OWB](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/OWB) · K121444 # FLAT PANEL DETECTOR (K121444) _Canon, Inc. - Medical Equpment Group · OWB · Jun 7, 2012 · Radiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/OWB/K121444 ## Device Facts - **Applicant:** Canon, Inc. - Medical Equpment Group - **Product Code:** [OWB](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/OWB.md) - **Decision Date:** Jun 7, 2012 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 892.1650 - **Device Class:** Class 2 - **Review Panel:** Radiology ## 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 spot-film devices. The device is also intended to replace fluoroscopic images obtained through image intensifier technology. Not intended for mammography applications. ## Device Story CSX-20 is a digital radiography flat panel detector component for X-ray systems; captures X-ray images and converts them into high-resolution digital signals. Used in clinical settings (OR, clinic, ER) by physicians/technicians during diagnostic, surgical, and interventional procedures. Replaces traditional spot-film devices and image intensifier technology. Features 16-bit A/D conversion (upgraded from 14-bit in predicate) to improve resolution, signal-to-noise ratio, and tonal precision; supports higher frame rates (up to 240 fps). Output is a digital image displayed for clinician review to support diagnostic and interventional decision-making. Benefits include improved image quality and workflow efficiency compared to legacy intensifier systems. ## Clinical Evidence Bench testing only. No clinical data provided. Evidence includes performance testing, software validation, electrical safety, and electromagnetic compatibility testing. Device complies with US Performance Standards for radiographic equipment. ## Technological Characteristics Digital flat panel X-ray detector. 16-bit A/D conversion. Grayscale depth: 16384 gradations. Max frame rate: 240 fps. Component of an X-ray system. Not intended for mammography. ## Regulatory 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. ## Special Controls *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. ## Predicate Devices - Canon CSX-10 ([K111824](/device/K111824.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {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 Page 1 of 1 --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/OWB/K121444](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/OWB/K121444) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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