(27 days)
No
The document describes a digital radiography detector and its hardware/software changes, with no mention of AI or ML capabilities for image processing or analysis.
No.
The device is described as an x-ray imager intended to capture radiographic images for general purpose 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 explicitly details hardware components like a solid-state x-ray imager, detector units, and various boxes (X-ray Interface Box, Power Box). While software is mentioned as being updated, the core functionality relies on physical hardware for image capture.
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) outside of the body.
- Device Description: The description details how the device works by intercepting x-ray photons and converting them into digital images for display. This aligns with the function of a medical imaging device.
- 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 D1, (hereinafter referred to as CXDI-Pro) is a solid-state x-ray imager. The CXDI-Pro is a series of detectors, currently consisting of the CXDI-703C Wireless detector unit, also called the AR-D3543W detector. The detector intercepts 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, and the images will be displayed on monitors. The digital value can be communicated to the operator console via a wired or wireless connection. The subject of this Special 510(k) submission is a change to the DIGITAL RADIOGRAPHY CXDI-710C Wireless (hereinafter referred to as CXDI-710C) to make the CXDI-Pro. This change will remove the Docking Station, Multi Box, and Status Indicator as optional components and add the X-ray Interface Box and Power Box as optional components. The software has been updated from CXDI Control Software V2.16 to CXDI Control Software V3.10. The case material has been changed from fiberglass to magnesium alloy. Bluetooth function has been added, and Standalone mode has been removed as a photographing mode. 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 changes to the CXDI-710C 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, 60601-2-54, 60601-1-6, and IEC 60529.
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. 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
September 30, 2021
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The symbol on the left is a stylized representation of the Department of Health & Human Services seal. The text on the right is in blue, with "FDA" in a larger font size than the rest of the text.
Canon Inc. % Mr. Gregory Woodard Biomedical Engineer Ken Block Consulting 800 East Campbell Road, Suite 202 RICHARDSON TX 75081
Re: K212553
Trade/Device Name: DIGITAL RADIOGRAPHY CXDI-Pro D1 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MOB
Dear Gregory Woodard:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated September 9, 2021. Specifically, FDA is updating this SE Letter (Typo in the Trade Name) as an administrative correction.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Laurel Burk, OHT7: Office of In Vitro Diagnostics and Radiological Health, 301-796-5933, laurel.burk(@fda.hhs.gov.
Sincerely, Laurel M Burk -S
Digitally signed by Laurel M. Burk -S
Date: 2021.09.30 14:31:00 -04'00'
Laurel Burk Assistant Director Diagnostic X-ray Systems Team 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
1
September 9, 2021
Image /page/1/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "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: K212553
Trade/Device Name: DIGITAL RADIOGRAPHY CXDI-Pro, D1 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB Dated: August 12, 2021 Received: August 13, 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
2
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 531-542 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 medical devices and radiation-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(@tda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Image /page/2/Picture/5 description: The image shows a digital signature. The signature is from Laurel M. Burk -S. The date of the signature is 2021.09.09, and the time is 10:30:16 -04'00'.
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
3
Indications for Use
510(k) Number (if known) K212553
Device Name DIGITAL RADIOGRAPHY CXDI-Pro 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) |
|---|
| ------------------------------------------------- |
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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4
Image /page/4/Picture/0 description: The image shows the word "Canon" in a bold, red font. The letters are closely spaced together, creating a solid block of text. The logo is simple and recognizable, representing the well-known electronics company.
5. 510(k) SUMMARY
| Applicant/Sponsor: | 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: | August 12, 2021 |
| Submission Type: | Special 510(k) Submission |
| Proposed Device: | Manufacturer: Canon Inc.
Trade Name: DIGITAL RADIOGRAPHY CXDI-Pro
D1
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: K170332
Manufacturer: Canon Inc.
Trade Name: DIGITAL RADIOGRAPHY CXDI-710C
Common Name: Solid State X-ray Imager
Classification Name: Stationary X-ray System
Classification: 892.1680, Stationary X-ray System
Product Code: MQB |
| Reference Devices: | 510k Number: K192632
Manufacturer: Canon Inc.
Trade Name: DIGITAL RADIOGRAPHY CXDI-702C
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 DIGITAL RADIOGRAPHY CXDI-Pro, also called the D1, (hereinafter referred
to as CXDI-Pro) is a solid-state x-ray imager. The CXDI-Pro is a series of detectors,
currently consisting of the CXDI-703C Wireless detector unit, also called the AR-
D3543W detector. The detector intercepts 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, and the images will be displayed on monitors. The digital value can
be communicated to the operator console via a wired or wireless connection. |
5
| | The subject of this Special 510(k) submission is a change to the DIGITAL
RADIOGRAPHY CXDI-710C Wireless (hereinafter referred to as CXDI-710C) to
make the CXDI-Pro. This change will remove the Docking Station, Multi Box, and
Status Indicator as optional components and add the X-ray Interface Box and Power
Box as optional components. The software has been updated from CXDI Control
Software V2.16 to CXDI Control Software V3.10. The case material has been
changed from fiberglass to magnesium alloy. Bluetooth function has been added, and
Standalone mode has been removed as a photographing mode. Together, these
changes make up the CXDI-Pro. |
|-------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for Use: | The Indication for Use statement is identical to the predicate device. The intended use
of the modified device, as described in the labeling, has not changed as a result of the
modification(s).
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. |
| Summary of
Technological
Characteristics: | Comparison with the predicate devices shows the characteristics of the proposed
modifications (changes to the optional accessories, software change from V2.16 to
V3.10, change in case material from fiberglass to magnesium alloy, addition of
Bluetooth, and removal of Standalone mode) to the CXDI-Pro to be substantially |
| Proposed Device | Predicate Device | Reference Devices | ||
|---|---|---|---|---|
| Trade Name | DIGITAL RADIOGRAPHY | |||
| CXDI-Pro / D1 | DIGITAL RADIOGRAPHY | |||
| CXDI-710C | DIGITAL RADIOGRAPHY | |||
| CXDI-702C | ||||
| 510(k) | ||||
| Submitter | ||||
| [Number] | Canon Inc. | |||
| [TBD] | Canon Inc. | |||
| [K170332] | Canon, Inc. | |||
| [K192632] | IDENTICAL | |||
| Indication 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. | The DIGITAL RADIOGRAPHY | |||
| CXDI-710C Wireless 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-702C Wireless 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 | General Radiography | IDENTICAL |
| Case Material | Magnesium alloy | Fiberglass | Magnesium Alloy | MODIFIED |
| Scintillator | CsI(TI) | |||
| [Cesium Iodide doped with | ||||
| Thallium] | CsI(TI) | |||
| [Cesium Iodide doped with | ||||
| Thallium] | CsI(TI) | |||
| [Cesium Iodide doped with | ||||
| Thallium] | IDENTICAL | |||
| Pixel Pitch | 140μm | 125μm | 125μm | MODIFIED |
| Spatial | ||||
| Resolution | 35% [MTF@2lp/mm] | 35% [MTF@2lp/mm] | 35% [MTF@2lp/mm] | IDENTICAL |
| IP Level | IP55 | IPX7 | IP54 | MODIFIED |
equivalent to the predicate device.
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Image /page/6/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.
| Standard
Components | Detector (Sensor), Battery Pack
(LB-4A), Documentation
(Manuals) | Detector (Sensor), Battery Pack
(LB-4A), Documentation
(Manuals) | Detector (Sensor), Battery Pack
(LB-4A), Documentation
(Manuals) | IDENTICAL |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Optional
Components | Battery Charger (BC-1A), 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) | Docking Station (DS-4A), Battery
Charger (BC-1A), Battery Pack
(LB-4A), Multi Box (MB-4A),
Status Indicator (SI-4A), Wiring
Cable (WC-4A), PC Connection
Cable (CP-4A), Ready Indicator
(RI-3A) | Docking Station (DS-4A), Battery
Charger (BC-1A), Battery Pack
(LB-4A), Multi Box (MB-4A),
Status Indicator (SI-4A), Wiring
Cable (WC-4A), PC Connection
Cable (CP-4A), Ready Indicator
(RI-3A), X-ray Interface Box
(XB-1A) | MODIFIED |
| Software | CXDI Control Software V3.10 | CXDI Control Software V2.16 | CXDI Control Software V2.19 | MODIFIED |
| Photographing
Mode | Standard Synchronization Mode,
Non Generator Connection Mode | Standard Synchronization Mode,
Non Generator Connection Mode,
Standalone Mode | Standard Synchronization Mode,
Non Generator Connection Mode | MODIFIED |
| Wireless
Communication | IEEE 802.11n/ac/a/g/b
2.4GHz/5GHz
Bluetooth Low Energy | IEEE 802.11n
2.4GHz/5GHz | IEEE 802.11n/a/g/b
2.4GHz/5GHz | MODIFIED |
The User's and Installation Manuals provide 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 User's Manual explains how to use the detector and other equipment. Connected medical equipment, such as x-ray generators, must comply with IEC 60601-1.
Performance: The fundamental scientific technology of the CXDI-Pro has not been modified. The changes are an update to the software in the CXDI-710C, changes to the optional accessories, change in case material from fiberglass to magnesium alloy, addition of Bluetooth, and removal of Standalone mode.
Evaluation of the changes to the CXDI-710C 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, 60601-2-54, 60601-1-6, and IEC 60529.
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. Therefore, the verification/validation activities conducted support a determination of substantial equivalence for the CXDI-Pro.