(17 days)
No
The summary describes a digital radiography system with standard image processing software updates and accessory compatibility changes. There is no mention of AI, ML, or related concepts like deep learning, neural networks, or training/test sets for algorithmic development.
No
The device is described as an x-ray imager intended for capturing and displaying radiographic images for diagnostic procedures, not for treatment or therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the 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."
No
The device description clearly states it is a "solid-state x-ray imager" and describes physical components like detectors, scintillators, and photodetectors, which are hardware. While it includes software (CXDI Control Software), it is not solely software.
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 for conventional film/screen radiographic examinations" and to "capture, for display, radiographic images of human anatomy." This describes an imaging device used to visualize internal structures of the body, not a device used to examine specimens derived from the human body (like blood, urine, or tissue) in vitro (outside the body).
- Device Description: The description details how the device captures X-ray photons and converts them into digital images for display. This process is entirely focused on imaging the patient directly.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other components typically associated with in vitro diagnostics.
Therefore, the device described is a medical imaging device, specifically a digital radiography system, and not an IVD.
N/A
Intended Use / Indications for Use
The DIGITAL RADIOGRAPHY CXDI-Pro / D1 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.
Product codes
MQB
Device Description
The DIGITAL RADIOGRAPHY CXDI-Pro, also called the DIGITAL RADIOGRAPHY D1, (hereinafter referred to as CXDI-Pro) is a solid-state x-ray imager. The CXDI-Pro is a series of detectors, and in the predicate device (K220098) consists of the CXDI-703C Wireless and CXDI-403C Wireless detectors, also called the AR-D3543W and AR-D4343W detectors respectively. The detectors intercept x-ray photons, and the scintillator emits visible spectrum photons that illuminate an array of photodetectors that create electrical signals. After the electrical signals are generated, the signals are converted to digital values The digital values are sent to the PC via a wired or wireless connection, converted to images with the CXDI Control Software, and then displayed on the PC/monitors The PC/monitors used with the CXDI-Pro are not a part of this submission.
The subject of this Special 510(k) submission is a change to the predicate device, including compatibility with the Multi Box and Status Indicator, DIGITAL RADIOGRAPHY CXDI-Elite components that were cleared under K213780. The Status Indicator can be used when the proposed device is used in combination with the Multi Box. In addition, the CXDI Control Software has been updated from V3.10.0.8 to V3.10.2.2 to fix some bugs. Together, these changes make up the CXDI-Pro.
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
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)
Evaluation of the addition of the new detector and optional accessories confirmed that the changes did not impact CXDI-Pro conformance 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, 60601-1-6, and 60601-2-54. These verification/validation activities successfully demonstrated that the device continues to meet the standards for the areas impacted by the modifications to the predicate device and raises no new questions regarding either safety or effectiveness when compared to the predicate device. Clinical testing is not necessary for the current submission, based on the minor differences from the predicate device. Adequate verification and validation activities should be sufficient to demonstrate that the CXDI-Pro works as intended. Therefore, the verification/validation activities conducted support a determination of substantial equivalence for the CXDI-Pro.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
July 15, 2022
Image /page/0/Picture/1 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 includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font size below.
Canon Inc. % Saori Sawaki Business Manager, Regulatory Consultant Ken Block Consulting 800 E. Campbell Road, Suite 202 RICHARDSON TX 75081
Re: K221876
Trade/Device Name: Digital Radiography CXDI-Pro, Digital Radiography D1 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB Dated: June 27, 2022 Received: June 28, 2022
Dear Saori Sawaki:
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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 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 (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 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,
Laurel Burk, Ph.D. Assistant Director Diagnostic X-Ray Systems Team OHT 8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K221876
Device Name DIGITAL RADIOGRAPHY CXDI-Pro DIGITAL RADIOGRAPHY D1
Indications for Use (Describe)
The DIGITAL RADIOGRAPHY CXDI-Pro / D1 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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X 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 shows the word "Canon" in a bold, red font. The word is slightly blurred, giving it a sense of depth. Below the word "Canon" is the text "510(-) SUMMARY", which is smaller and in a different font.
| STU(K) SUMMAK Y | |
|---|---|
| Applicant/ Sponsor: | Canon Inc.
9-1 Imaikami-cho
Nakahara-ku, Kanagawa 211-8501 JAPAN |
|---------------------|------------------------------------------------------------------------|
| Contact Person: | Mr. Akira Hirai |
General Manager TEL: 81-3-3758-2111 FAX: 044-739-6695 hirai.akira@mail.canon
Date Prepared: June 27, 2022
Submission Type: Special 510(k) Submission
| Proposed Device | Manufacturer: | Canon Inc.
DIGITAL RADIOGRAPHY CXDI-Pro
DIGITAL RADIOGRAPHY D1 | | |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|--|--|
| | Common Name: | Solid State X-Ray Imager (Flat Panel/Digital Imager) | | |
| | Classification Name: | Stationary X-ray System | | |
| | Product Code: | MQB | | |
| | Regulation: | 892.1680, Stationary X-ray System | | |
| Predicate Device: | Clearance: | K220098 | | |
| | Manufacturer: | Canon Inc. | | |
| | Trade Name: | DIGITAL RADIOGRAPHY CXDI-Pro
DIGITAL RADIOGRAPHY D1 | | |
| | Common Name: | Solid State X-ray Imager (Flat Panel/Digital Imager) | | |
| | Classification Name: | Stationary X-ray System | | |
| | Product Code: | MQB | | |
| | Regulation: | 892.1680, Stationary X-ray System | | |
| Device
Description: | The DIGITAL RADIOGRAPHY CXDI-Pro, also called the DIGITAL
RADIOGRAPHY D1, (hereinafter referred to as CXDI-Pro) is a solid-state x-ray
imager. The CXDI-Pro is a series of detectors, and in the predicate device
(K220098) consists of the CXDI-703C Wireless and CXDI-403C Wireless
detectors, also called the AR-D3543W and AR-D4343W detectors respectively.
The detectors intercept x-ray photons, and the scintillator emits visible spectrum
photons that illuminate an array of photodetectors that create electrical signals.
After the electrical signals are generated, the signals are converted to digital values
The digital values are sent to the PC via a wired or wireless connection, converted
to images with the CXDI Control Software, and then displayed on the PC/monitors
The PC/monitors used with the CXDI-Pro are not a part of this submission. | | | |
| | The subject of this Special 510(k) submission is a change to the predicate device,
including compatibility with the Multi Box and Status Indicator, DIGITAL
RADIOGRAPHY CXDI-Elite components that were cleared under K213780. The
Status Indicator can be used when the proposed device is used in combination with
the Multi Box. In addition, the CXDI Control Software has been updated from
V3.10.0.8 to V3.10.2.2 to fix some bugs. Together, these changes make up the
CXDI-Pro. | | | |
4
Image /page/4/Picture/0 description: The image shows the word "Canon" in a large, red, bold font. Below the word "Canon" is the text "510(k) SUMMARY" in a smaller, black, bold font. The text is centered below the word "Canon".
| Indications for
Use: | The DIGITAL RADIOGRAPHY CXDI-Pro / DIGITAL RADIOGRAPHY D1
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. |
|-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Summary of
Technological
Characteristics: | Comparison with the predicate device shows the technological characteristics of
the CXDI-Pro is substantially equivalent to the predicate device. |
| | The major differences between the CXDI-Pro and the predicate are differences in
the components and a newer version of the CXDI control software. The proposed
indications for use statement is identical to the indications for use statement of the |
predicate device.
| Proposed Device | Predicate Device | ||||
|---|---|---|---|---|---|
| Trade Name | DIGITAL RADIOGRAPHY CXDI-Pro / D1 | DIGITAL RADIOGRAPHY CXDI-Pro / D1 | |||
| 510(k) Submitter | |||||
| [Number] | Canon Inc. | ||||
| [TBD] | Canon Inc. | ||||
| [K220098] | IDENTICAL | ||||
| Indication for Use | The DIGITAL RADIOGRAPHY CXDI-Pro / | ||||
| DIGITAL RADIOGRAPHY D1 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-Pro / | ||||
| DIGITAL RADIOGRAPHY D1 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 | ||||
| Application | General Radiography | General Radiography | |||
| Components | Detector (Sensor) | ||||
| Documentation (Manuals) | |||||
| Battery Charger (BC-1A/BC-01) | |||||
| Battery Pack (LB-4A) | |||||
| X-ray Interface Box (XB-1A) | |||||
| Power Box (PB-01) | |||||
| Wiring Cable (WC-01) | |||||
| PC Connection Cable (CP-01) | |||||
| Ready Indicator (RI-3A) | |||||
| Detector Stand (DS-01) | Detector (Sensor) | ||||
| Documentation (Manuals) | |||||
| Battery Charger (BC-1A/BC-01) | |||||
| Battery Pack (LB-4A) | |||||
| X-ray Interface Box (XB-1A) | |||||
| Power Box (PB-01) | |||||
| Wiring Cable (WC-01) | |||||
| PC Connection Cable (CP-01) | |||||
| Ready Indicator (RI-3A) | |||||
| Detector Stand (DS-01) | IDENTICAL | ||||
| Other Compatible | |||||
| Components | Multi Box (MB-02) | ||||
| Status Indicator (SI-01/SI-4A) | N/A | MODIFIED | |||
| Detector Sensor | CXDI-703C Wireless | ||||
| AR-D3543W | CXDI-403C Wireless | ||||
| AR-D4343W | CXDI-703C Wireless | ||||
| AR-D3543W | CXDI-403C Wireless | ||||
| AR-D4343W | IDENTICAL | ||||
| External Dimensions | 384 x 460 x 15.5 mm | 460 x 460 x 15.7 mm | 384 x 460 x 15.5 mm | 460 x 460 x 15.7 mm | IDENTICAL |
| Case Material | Magnesium alloy | Magnesium alloy | IDENTICAL | ||
| Detector Technology | TFT | TFT | IDENTICAL | ||
| Pixel Pitch | 140um | 140μm | IDENTICAL | ||
| Scintillator | CsI(Tl) | ||||
| [Cesium Iodide doped with Thallium] | CsI(Tl) | ||||
| [Cesium Iodide doped with Thallium] | IDENTICAL | ||||
| Spatial | |||||
| Resolution | 35% [MTF@2lp/mm] | 35% [MTF@2lp/mm] | IDENTICAL | ||
| DQE | 58% [@0.5 lp/mm, 3.5 uGy] | 58% [@0.5 lp/mm, 3.5 uGy] | IDENTICAL | ||
| IP Level | IP55 | IP55 | IDENTICAL | ||
| Software | CXDI Control Software V3.10.2.2 | CXDI Control Software V3.10.0.8 | MODIFIED | ||
| Wireless | |||||
| Communication | IEEE 802.11n/ac/a/g/b | ||||
| 2.4GHz/5GHz | |||||
| Bluetooth Low Energy | IEEE 802.11n/ac/a/g/b | ||||
| 2.4GHz/5GHz | |||||
| Bluetooth Low Energy | IDENTICAL | ||||
| Photographing Mode | Standard Synchronization Mode, | ||||
| Non Generator Connection Mode | Standard Synchronization Mode, | ||||
| Non Generator Connection Mode | IDENTICAL |
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Image /page/5/Picture/1 description: The image shows the word "Canon" in a large, red, bold font. Below that, the words "510(k) SUMMARY" are printed in a smaller, black, bold font. The text is centered on the image.
| Summary of
Non-Clinical /
Test Data: | The fundamental scientific technology of the CXDI-Pro has not been modified.
The changes are the addition of optional accessories, a Multi Box and Status
Indicator; the update to the detector firmware from 01.00.02.00 to 01.01.03.00;
and the update to the CXDI Control Software from 3.10.0.8 to 3.10.2.2. |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Evaluation of the addition of the new detector and optional accessories confirmed
that the changes did not impact CXDI-Pro conformance 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, 60601-1-6, and 60601-2-54. | |
| These verification/validation activities successfully demonstrated that the device
continues to meet the standards for the areas impacted by the modifications to the
predicate device and raises no new questions regarding either safety or
effectiveness when compared to the predicate device. Clinical testing is not
necessary for the current submission, based on the minor differences from the
predicate device. Adequate verification and validation activities should be
sufficient to demonstrate that the CXDI-Pro works as intended. Therefore, the
verification/validation activities conducted support a determination of substantial
equivalence for the CXDI-Pro. | |
| The proposed device follows the applicable elements of the following FDA
guidance documents: Guidance for the Submission of 510(k)s for Solid State X-ray
Imaging Devices, Guidance for the Content of Premarket Submissions for
Software contained in Medical Devices, Content of Premarket Submissions for
Management of Cybersecurity in Medical Devices, and Use of International
Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1:
Evaluation and testing within a risk management process." | |
| Conclusion: | Canon Inc. considers the DIGITAL RADIOGRAPHY CXDI-Pro / D1 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. |