(26 days)
No
The summary describes automatic stitching software, which is a form of image processing, but does not mention or imply the use of AI or ML techniques for this function. The focus is on combining images from multiple detectors.
No.
The device is described as providing "digital image capture, processing, and display for conventional film/screen radiographic examinations" and is intended for "general purpose diagnostic procedures," indicating it is an imaging or diagnostic device, not a therapeutic one.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures."
No
The device is described as "a change to the CXDI Control Software to incorporate the ability to capture an automatically stitched long length image in a single exposure." However, it explicitly states that this software is used "when used with a compatible CXDI detector" and that the "One Shot Long Length stitches long length images into a single image which is accomplished by using multiple detectors, a single exposure, and the automatic stitching software." This indicates that the software is an integral part of a larger system that includes hardware (the CXDI detectors). The submission also discusses the performance and safety of the detectors, further confirming it's not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "digital image capture, and display for conventional film/screen radiographic examinations." This is related to medical imaging, not testing samples from the human body (like blood, urine, or tissue) outside of the body.
- Device Description: The description focuses on capturing and stitching X-ray images. This is a function of a medical imaging system, not an in vitro diagnostic device.
- Input Imaging Modality: The input modality is X-ray, which is a medical imaging technique, not a method used in IVD testing.
IVD devices are used to examine specimens obtained from the human body to provide information for diagnosis, monitoring, or screening. This device is used to create images of the human body using X-rays.
N/A
Intended Use / Indications for Use
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, 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 subject of this Special 510(k) submission is a change to the CXDI Control Software to incorporate the ability to capture an automatically stitched long length image in a single exposure. The addition of the One Shot Long Length to the cleared Scatter Correction of CXDI Series is the subject of this Special 510(k) Submission. The One Shot Long Length stitches long length images into a single image which is accomplished by using multiple detectors, a single exposure, and the automatic stitching software. The One Shot Long Length software feature along with the Scatter Correction cleared under K153312 make up the Enhanced Feature Software Pack for CXDI Series. The Scatter Correction clearance and compatible detectors are not impacted by this submission. This submission adds the One Shot Long Length feature to limited compatible FPDs. The One Shot Long Length feature included in the Enhanced Feature Software Pack for CXDI Series also includes features for manual stitching to allow for users to manually adjust and fine-tune the stitch positions after the automatic stitch operation. By incorporating the One Shot Long Length imaging into the CXDI Control Software, images up to 120cm in length can be acquired in one exposure. The firmware within the flat panel detectors did not require updating. The flat panel detectors that have been previously cleared by FDA and are compatible with the Enhanced Feature Software Pack for CXDI Series have not been physically modified and performance have not changed.
Mentions image processing
Yes
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)
Performance: The hardware within the Canon Digital Radiography CXDI Series Detectors 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 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.
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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Canon, Inc. % Ms. Katie Reneson Regulatory Specialist Ken Block Consulting 800 East Campbell Road. Suite 202 RICHARDSON TX 75081
March 13, 2019
Re: K190368
Trade/Device Name: Enhanced Feature Software Pack for CXDI Series Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB Dated: February 14, 2019 Received: February 15, 2019
Dear Ms. Reneson:
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
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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
(http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael D. O'Hara
For
Thalia Mills, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
Device Name
Enhanced Feature Software Pack for CXDI Series
Indications for Use (Describe)
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, 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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3
Image /page/3/Picture/1 description: The image contains the word "Canon" in red font. The font is bold and slightly italicized. The word is easily readable and takes up most of the image.
5. Special 510(k) SUMMARY
| Submitter: | Canon, Inc.
30-2 Shimomaruko, 3-chrome
Ohta-ku, Tokyo 146-8501 Japan |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mr. Tatsuya Yamazaki
General Manager
TEL: 81-3-3758-2111;
FAX: 81-3-5482-3960
yamazaki.tatsuya@mail.canon |
| Date Prepared: | February 14, 2019 |
| Submission Type: | Special 510(k) Submission |
| Trade Name: | Enhanced Feature Software Pack for CXDI Series |
| Common Name: | Solid State X-Ray Imager (Flat Panel/Digital Imager) |
| Regulatory Number: | 21 CFR 892.1680 |
| Classification Name: | Stationary X-ray system |
| Product Code: | MQB |
| Primary Predicate #1: | MQB K153312 Scatter Correction for CXDI Series |
| Predicate #2: | MQB Canon DIGITAL RADIOGRAPHY CXDI Series Detectors
510(k) # Models
K170332 CXDI-710C Wireless
K171270 CXDI-410C Wireless |
The subject of this Special 510(k) submission is a change to the CXDI Control Device Description: Software to incorporate the ability to capture an automatically stitched long length image in a single exposure. The addition of the One Shot Long Length to the cleared Scatter Correction of CXDI Series is the subject of this Special 510(k) Submission. The One Shot Long Length stitches long length images into a single image which is accomplished by using multiple detectors, a single exposure, and the automatic stitching software. The One Shot Long Length software feature along with the Scatter Correction cleared under K153312 make up the Enhanced Feature Software Pack for CXDI Series. The Scatter Correction clearance and compatible detectors are not impacted by this submission. This submission adds the One Shot Long Length feature to limited compatible FPDs. The One Shot Long Length feature included in the Enhanced Feature Software Pack for CXDI Series also includes features for manual stitching to allow for users to manually adjust and fine-tune the stitch positions after the automatic stitch operation. By incorporating the One Shot Long Length imaging into the CXDI Control Software, images up to 120cm in length can be acquired in one exposure. The firmware within the flat panel detectors did not require updating. The flat panel detectors that have been previously cleared by FDA and are compatible with the Enhanced Feature Software Pack for CXDI Series have not been physically modified and performance have not changed.
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Image /page/4/Picture/0 description: The image shows the word "Canon" in red font. The font is bold and slightly italicized. The word is easily readable and takes up most of the image.
Indications for Use Statement
The intended use of the modified device, as described in the labeling, has not changed as a result of the modification(s).
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.
Summary of Technological Characteristics:
Comparisons with the predicate devices show the characteristics of the proposed addition of the One Shot Long Length feature to the Enhanced Feature Software Pack for CXDI Series to be substantially equivalent to the predicate device(s). The One Shot Long Length feature of the Enhanced Feature Software Pack for CXDI Series can only be used with compatible Canon CXDI detectors CXDI-710C Wireless, CXDI-410C Wireless.
| Trade Name | Proposed Device
Enhanced Feature Software Pack
for CXDI Series | Predicate
Control Software V2.14
Scatter Correction | |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| 510(k)
Submitter
[Number] | Canon, Inc.
[K190368] | Canon, Inc.
[K153312] | IDENTICAL |
| Indication
for Use | 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. | 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. | IDENTICAL |
| 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 | IDENTICAL |
| 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. | N/A | MODIFIED |
| Software
/Version | CXDI Control Software V2.17 | CXDI Control Software V2.14
(highest version cleared
previously) | MODIFIED |
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Image /page/5/Picture/0 description: The image shows the word "Canon" in red, bold letters. The font is sans-serif and slightly italicized. The word is centered and takes up most of the frame.
| Trade Name | Proposed Device
Canon DIGITAL
RADIOGRAPHY CXDI Series
Detectors containing Enhanced
Feature Software Pack for CXDI
Series | Predicate Device
Canon DIGITAL
RADIOGRAPHY CXDI
Series Detectors | |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| 510(k)
Submitter
[Number] | Canon, Inc.
[K190368] | Canon, Inc.
[K170332, K171270] | IDENTICAL |
| Indication
for Use | The DIGITAL
RADIOGRAPHY CXDI Series
Detectors provides digital image
capture for conventional
film/screen radiographic
examinations. This device is
intended to capture for display
radiographic images of human
anatomy, and to replace
radiographic film/screen systems
in all general purpose diagnostic
procedures. This device is not
intended for mammography
applications. | The DIGITAL
RADIOGRAPHY CXDI
Series Detectors provides
digital image capture for
conventional film/screen
radiographic examinations.
This device is intended to
capture for display
radiographic images of human
anatomy, and to replace
radiographic film/screen
systems in all general purpose
diagnostic procedures. This
device is not intended for
mammography applications. | IDENTICAL |
| 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 | IDENTICAL |
| 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. | N/A | MODIFIED |
| Firmware
/Version | 04-02-0c-00 | 04-02-0b-00 | MODIFIED |
Performance: The hardware within the Canon Digital Radiography CXDI Series Detectors 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 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. Canon, Inc. considers the Enhanced Feature Software Pack for CXDI Series to be Conclusion: 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.