(59 days)
Not Found
Yes
The device description explicitly states that the "Intelligent NR function was developed using machine-learning and trained by using an existing clinical image database".
No.
The device is intended for digital image capture, processing, and display for diagnostic radiography, not for therapeutic purposes.
Yes
The "Intended Use / Indications for Use" section explicitly states, "This device is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures".
No
The device is described as a part of the Canon radiography system and is used in conjunction with compatible Canon detectors, which are hardware components. While the Intelligent NR function itself is software, it is integrated into a larger system that includes 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, processing, and display for conventional film/screen radiographic examinations." This describes a medical imaging system used for diagnostic purposes based on visual interpretation of X-ray images.
- Device Description: The description focuses on the software's function in processing X-ray images to reduce noise. It doesn't mention analyzing biological samples (blood, urine, tissue, etc.) or providing information about a patient's health status based on such analysis.
- Lack of IVD Characteristics: IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device operates in vivo (within the body) by capturing images generated by X-rays passing through the patient.
The device is a component of a medical imaging system used for diagnostic radiology, which is distinct from in vitro diagnostics.
No
The letter does not state that the FDA has reviewed and approved or cleared a PCCP for this specific device.
Intended Use / Indications for Use
As a part of the Canon radiography system, the CXDI Control Software when used with a compatible Canon detector is intended to provide digital image capture, processing, and display for conventional film/screen radiographic examinations. This device is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures including specialist areas like intensive care, trauma, and pediatric work. This device is not intended for fluoroscopic, angiographic, or mammography applications.
Product codes
MQB
Device Description
The Intelligent NR (Intelligent Noise Reduction) function is a part of the CXDI Control software for the Canon detectors (with version 3.10 of the CXDI Control Software) that makes use of the Intelligent NR function to reduce noise for X-ray images taken using the Canon detectors. The Intelligent NR function was developed using machine-learning and trained by using an existing clinical image database to learn the characteristics of noises and create noise reduced images. The Intelligent NR function does not perform machine learning after release to users. The CXDI control software, which Intelligent NR is a part of, provides system control, controls GUI on the monitor, and processes images. The Intelligent NR function works on a PC and displays to a monitor. The Intelligent NR function is used in conjunction with the cleared Canon detectors compatible with CXDI Control Software V3.10. The firmware within compatible Canon detectors to be used with this device is unchanged, and no firmware update is necessary for compatibility with the Intelligent NR.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
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
The Intelligent NR function was developed using machine-learning and trained by using an existing clinical image database to learn the characteristics of noises and create noise reduced images.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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.
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September 17, 2021
Image /page/0/Picture/1 description: The image contains two logos. On the left is the Department of Health & Human Services logo, which features a stylized caduceus. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Canon Inc. % Mr. Gregory Woodard Biomedical Engineer Ken Block Consulting 800 East Campbell Road, Suite 202 RICHARDSON TX 75081
Re: K212269
Trade/Device Name: Intelligent NR Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB Dated: July 19, 2021 Received: July 20, 2021
Dear Mr. Woodard:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
542 of the Act); 21 CFR 1000-1050.
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
. for
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K212269
Device Name Intelligent NR
Indications for Use (Describe)
As a part of the Canon radiography system, the CXDI Control Software when used with a compatible Canon detector is intended to provide digital image capture, processing, and display for conventional film/screen radiographic examinations. This device is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures including specialist areas like intensive care, trauma, and pediatric work. This device is not intended for fluoroscopic, angiographic, or mammography applications.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) SUMMARY
| Submitter: | Canon Inc.
30-2 Shimomaruko, 3-chrome
Ohta-ku, Tokyo 146-8501 Japan | | |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Contact Person: | Mr. Akira Hirai
General Manager
TEL: 81-3-3758-2111;
FAX: 044-739-6695
hirai.akira@mail.canon | | |
| Date Prepared: | July 19, 2021 | | |
| Submission Type: | Traditional 510(k) Submission | | |
| Proposed Device: | Manufacturer: Canon Inc.
Trade Name: Intelligent NR
Common Name: Solid State X-Ray Imager (Flat Panel/Digital Imager)
Classification Name: Stationary X-ray System
Classification: 892.1680, Stationary X-ray System
Product Code: MQB | | |
| Predicate Device: | 510k Number: K190368
Manufacturer: Canon Inc.
Trade Name: Enhanced Feature Software Pack for CXDI Series
Common Name: Solid State X-Ray Imager (Flat Panel/Digital Imager)
Classification Name: Stationary X-ray System
Classification: 892.1680, Stationary X-ray System
Product Code: MQB | | |
| Device Description: | The Intelligent NR (Intelligent Noise Reduction) function is a part of the CXDI
Control software for the Canon detectors (with version 3.10 of the CXDI Control
Software) that makes use of the Intelligent NR function to reduce noise for X-ray
images taken using the Canon detectors. The Intelligent NR function was developed
using machine-learning and trained by using an existing clinical image database to
learn the characteristics of noises and create noise reduced images. The Intelligent
NR function does not perform machine learning after release to users. The CXDI
control software, which Intelligent NR is a part of, provides system control, controls
GUI on the monitor, and processes images. The Intelligent NR function works on a
PC and displays to a monitor. The Intelligent NR function is used in conjunction
with the cleared Canon detectors compatible with CXDI Control Software V3.10.
The firmware within compatible Canon detectors to be used with this device is
unchanged, and no firmware update is necessary for compatibility with the
Intelligent NR. | | |
| Indication for Use: | As a part of the Canon radiography system, the CXDI Control Software when used
with a compatible Canon detector is intended to provide digital image capture, | | |
| | Proposed Device | Predicate Device | |
| Trade Name | Intelligent NR | Enhanced Feature Software Pack for CXDI Series | |
| 510(k)
Submitter
[Number] | Canon Inc.
[TBD] | Canon Inc.
[K190368] | |
| Indication for
Use | As a part of the Canon radiography system, the CXDI
Control Software when used with a compatible Canon
detector is intended to provide digital image capture,
processing, and display for conventional film/screen
radiographic examinations. This device is intended to
replace radiographic film/screen systems in all general
purpose diagnostic procedures including specialist
areas like intensive care, trauma, and pediatric work.
This device is not intended for fluoroscopic,
angiographic, or mammography applications. | As a part of the CXDI series radiography system, the
CXDI Control Software when used with a compatible
CXDI detector is intended to provide digital image
capture, processing, and display for conventional
film/screen radiographic examinations. This device is
intended to replace radiographic film/screen systems
in all general purpose diagnostic procedures including
specialist areas like intensive care, trauma, and
pediatric work. This device is not intended for
fluoroscopic, angiographic, or mammography
applications. | |
| Software /
Version | CXDI Control Software V3.10 | CXDI Control Software V2.17 | |
| Scatter
Correction | An image can be created (with high contrasts) by
using software algorithm, in clinical field, without a
grid | An image can be created (with high contrasts) by
using software algorithm, in clinical field, without a
grid | |
| One Shot
Long Length
Imaging | One exposure to obtain images across multiple
detectors, automatically stitched together with ability
to make manual adjustments after the automatic
stitching. | One exposure to obtain images across multiple
detectors, automatically stitched together with ability
to make manual adjustments after the automatic
stitching. | |
| Intelligent NR
Function | Process to reduce noise from the taken images by
using function machine trained on characteristics of
noises included in X-ray image signals using an
existing clinical image database | N/A | |
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processing, and display for conventional film/screen radiographic examinations. This device is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures including specialist areas like intensive care, trauma, and pediatric work. This device is not intended for fluoroscopic, angiographic, or mammography applications.
Summary of Comparison with the predicate devices shows the characteristics of the proposed Technological device to be substantially equivalent to the predicate device. Characteristics:
The Operation Manual provides 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 Operation Manual explains how to use the software and other equipment.
Performance: The hardware within the Canon Digital Radiography Canon Detectors used with the Intelligent NR has not been modified, the detectors have the same performance, biocompatibility, effectiveness, and safety and is substantially equivalent to the predicate device. The risks and hazardous impacts of the device modification were analyzed by FMEA methodology. The specific risk control and protective measures to mitigate the risks from the modification were reviewed and implemented as part of product design. The overall assessment concluded that all identified risks and hazardous conditions were successfully mitigated and accepted.
As reported in prior submissions to FDA, the compatible detectors comply with the U.S. Performance Standard for radiographic equipment and with relevant voluntary
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safety standards for Electrical Safety and Electromagnetic Compatibility testing, specifically IEC standards 60601-1, 60601-1-2, 60601-1-3, and 60601-2-32. The wireless detectors also comply 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.
- Conclusion: Canon Inc. considers the Intelligent NR 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.