(26 days)
No
The summary describes a digital radiography system with hardware and software updates for image capture and display. There is no mention of AI, ML, or any related technologies for image analysis, interpretation, or other functions beyond basic image conversion and display. The performance studies focus on safety and equivalence to the predicate device, not on AI/ML performance metrics.
No
The device is described as an X-ray imager for capturing, displaying, and replacing film/screen systems in diagnostic procedures, which is a diagnostic function, not a therapeutic one.
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." This directly indicates its use in diagnostics.
No
The device description explicitly states that the CXDI-CS01 is a "solid-state x-ray imager" and a "series of detectors," which are hardware components. 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.
- Device Description: The description details how the device intercepts x-ray photons and converts them into digital images for display. This aligns with the function of a medical imaging system.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The provided text makes no mention of analyzing biological specimens or performing tests on samples outside the body.
Therefore, the DIGITAL RADIOGRAPHY CXDI-CS01 is a medical imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The DIGITAL RADIOGRAPHY CXDI-CS01 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-CS01 (hereinafter referred to as CXDI- CS01) is a solid-state x-ray imager. The CXDI-CS01 is a series of detectors and, in the predicate device submission (K222661), consists of the CXDI-702C Wireless, CXDI-402C Wireless, CXDI-710C Wireless, CXDI-810C Wireless, CXDI-410C Wireless, DIGITAL RADIOGRAPHY CXDI-Pro (CXDI-703C Wireless and CXDI-403C Wireless), and DIGITAL RADIOGRAPHY CXDI-Elite (CXDI-720C Wireless).
The CXDI-CS01 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. 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-CS01 are not a part of this submission.
The subject of this Special 510(k) submission is the changes to the predicate CXDI- CS01, which include the addition of the DIGITAL RADIOGRAPHY CXDI-Pro detector (CXDI-803C Wireless) and the DIGITAL RADIOGRAPHY CXDI-Elite detectors (CXDI-820C Wireless and CXDI-420C Wireless) to the CXDI-CS01 series of detectors, a firmware update of the DIGITAL RADIOGRAPHY CXDI-Pro and DIGITAL RADIOGRAPHY CXDI-Elite detectors from 01.01.03.00 to 01.02.00.01 and from F2.00.03.00 to 02.01.04.00 respectively, and a CXDI Control Software version update from V3.10.2.2 to V3.10.2.6 to fix bugs. Together, these changes make up the CXDI-CS01.
Mentions image processing
Yes
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 detectors confirmed that the change did not impact the conformance of CXDI-CS01 with the U.S. Performance Standard for radiographic equipment and relevant voluntary safety standards for Electrical safety and Electromagnetic Compatibility testing, specifically IEC standards 60601-1, 60601-1-2, 60601-1-3, 60601-1-6, 60601-2-54, 62220-1, 62304, and 62366. The design control activities and biocompatibility evaluation successfully demonstrated that the modifications to the predicate device raise no new questions regarding either safety or effectiveness. Clinical testing is not necessary for the current submission, based on the minor differences from the predicate device. Adequate detector bench testing should be sufficient to demonstrate that the subject detector, CXDI-CS01, works as intended. Therefore, the verification/validation activities conducted support a determination of substantial equivalence for the CXDI-CS01.
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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February 15, 2023
Image /page/0/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 & 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, USA Inc. % Saori Sawaki Business Manager/Regulatory Consultant Ken Block Consulting LLC 800 E Campbell Road, Suite 202 RICHARDSON TX 75081
Re: K230175
Trade/Device Name: Digital Radiography CXDI-CS01 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary X-Ray System Regulatory Class: Class II Product Code: MQB Dated: January 20, 2023 Received: January 20, 2023
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 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
1
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@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Lu Jiang
Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K230175
Device Name DIGITAL RADIOGRAPHY CXDI-CS01
Indications for Use (Describe)
The DIGITAL RADIOGRAPHY CXDI-CS01 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 201 Subpart D)Over-The-Counter Use (21 CFR 201 Subpart G) | Prescription Use (Part 21 CFR 201 Subpart D) | Over-The-Counter Use (21 CFR 201 Subpart G) | ||
|---|---|---|---|---|---|
| Prescription Use (Part 21 CFR 201 Subpart D) | Over-The-Counter Use (21 CFR 201 Subpart G) | ||||
Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the word "Canon" in red font. The font is bold and slightly italicized. The word is centered in the image and takes up most of the space.
510(k) Summary
K230175
| 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: 81-44-739-6695
hirai.akira@mail.canon | |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Date Prepared: | February 10, 2023 | |
| Subject Device | Manufacturer: Canon Inc.
Trade Name: DIGITAL RADIOGRAPHY CXDI-CS01
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
Class: II | |
| Predicate Device: | Clearance: K222661 dated September 27, 2022
Manufacturer: Canon Inc.
Trade Name: DIGITAL RADIOGRAPHY CXDI-CS01
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
Class: II | |
| Device
Description: | The DIGITAL RADIOGRAPHY CXDI-CS01 (hereinafter referred to as CXDI-
CS01) is a solid-state x-ray imager. The CXDI-CS01 is a series of detectors and, in
the predicate device submission (K222661), consists of the CXDI-702C Wireless,
CXDI-402C Wireless, CXDI-710C Wireless, CXDI-810C Wireless, CXDI-410C
Wireless, DIGITAL RADIOGRAPHY CXDI-Pro (CXDI-703C Wireless and
CXDI-403C Wireless), and DIGITAL RADIOGRAPHY CXDI-Elite (CXDI-720C
Wireless).
The CXDI-CS01 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. 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-CS01 are not a part of this
submission.
The subject of this Special 510(k) submission is the changes to the predicate CXDI-
CS01, which include the addition of the DIGITAL RADIOGRAPHY CXDI-Pro
detector (CXDI-803C Wireless) and the DIGITAL RADIOGRAPHY CXDI-Elite
detectors (CXDI-820C Wireless and CXDI-420C Wireless) to the CXDI-CS01
series of detectors, a firmware update of the DIGITAL RADIOGRAPHY CXDI-Pro
and DIGITAL RADIOGRAPHY CXDI-Elite detectors from 01.01.03.00 to
01.02.00.01 and from F2.00.03.00 to 02.01.04.00 respectively, and a CXDI Control | |
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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 centered and takes up most of the image.
| 510(k) Summary | K230175 |
|---|---|
| Software version update from V3.10.2.2 to V3.10.2.6 to fix bugs. Together, these changes make up the CXDI-CS01. | |
| Indications for Use: | The DIGITAL RADIOGRAPHY CXDI-CS01 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 proposed CXDI-CS01 is substantially equivalent to the predicate device. The major differences between the proposed CXDI-CS01 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. |
| New Device | Predicate Device | |
|---|---|---|
| Trade Name | DIGITAL RADIOGRAPHY CXDI-CS01 | DIGITAL RADIOGRAPHY CXDI-CS01 |
| 510(k) | ||
| Submitter | ||
| [Number] | Canon Inc. | |
| [K230175] | Canon Inc. | |
| [K222661] | ||
| Indications for | ||
| Use | The DIGITAL RADIOGRAPHY CXDI-CS01 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-CS01 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. | ||
| Application | General Radiography | General Radiography |
| Software | CXDI Control Software V3.10.2.6 | CXDI Control Software V3.10.2.2 |
| Components | Detectors | |
| Battery Pack (LB-4A) | ||
| Battery Charger (BC-1A/BC-01) | ||
| Multi Box (MB-4A/MB-02) | ||
| Power Box (PB-01) | ||
| Ready Indicator (RI-3A) | ||
| Status Indicator (SI-4A/SI-01) | ||
| Wiring Cable (WC-4A/WC-01) | ||
| PC Connection Cable (CP-4A/CP-01) | ||
| Docking Station (DS-4A) | ||
| Detector Stand (DS-01) | Detectors | |
| Battery Pack (LB-4A) | ||
| Battery Charger (BC-1A/BC-01) | ||
| Multi Box (MB-4A/MB-02) | ||
| Power Box (PB-01) | ||
| Ready Indicator (RI-3A) | ||
| Status Indicator (SI-4A/SI-01) | ||
| Wiring Cable (WC-4A/WC-01) | ||
| PC Connection Cable (CP-4A/CP-01) | ||
| Docking Station (DS-4A) | ||
| Detector Stand (DS-01) | ||
| Detector | CXDI-702C Wireless | |
| CXDI-402C Wireless | ||
| CXDI-710C Wireless | ||
| CXDI-810C Wireless | ||
| CXDI-410C Wireless | ||
| CXDI-Pro: | ||
| CXDI-703C Wireless | ||
| CXDI-803C Wireless | ||
| CXDI-403C Wireless | ||
| CXDI-Elite: | ||
| CXDI-720C Wireless | ||
| CXDI-420C Wireless | ||
| CXDI-820C Wireless | CXDI-702C Wireless | |
| CXDI-402C Wireless | ||
| CXDI-710C Wireless | ||
| CXDI-810C Wireless | ||
| CXDI-410C Wireless | ||
| CXDI-Pro: | ||
| CXDI-703C Wireless | ||
| CXDI-803C Wireless | ||
| CXDI-403C Wireless | ||
| CXDI-Elite: | ||
| CXDI-720C Wireless | ||
| New Device | Predicate Device | |
| Trade Name | DIGITAL RADIOGRAPHY CXDI-CS01 | DIGITAL RADIOGRAPHY CXDI-CS01 |
| Scintillator | CsI(Tl) | |
| [Cesium Iodide doped with Thallium] | CsI(Tl) | |
| [Cesium Iodide doped with Thallium] | ||
| CXDI-702C Wireless, CXDI-402C Wireless, CXDI-710C | ||
| Wireless, CXDI-810C Wireless, CXDI-410C Wireless, and | ||
| CXDI-Elite: | CXDI-702C Wireless, CXDI-402C Wireless, CXDI-710C | |
| Wireless, CXDI-810C Wireless, CXDI-410C Wireless, and | ||
| CXDI-Elite: | ||
| Pixel Pitch | 125μm | 125μm |
| CXDI-Pro: | CXDI-Pro: | |
| 140 μm | 140 μm | |
| CXDI-702C Wireless, CXDI-402C Wireless, CXDI-710C | ||
| Wireless, CXDI-810C Wireless, CXDI-410C Wireless, and | ||
| CXDI-Pro: | CXDI-702C Wireless, CXDI-402C Wireless, CXDI-710C | |
| Wireless, CXDI-810C Wireless, CXDI-410C Wireless, and | ||
| CXDI-Pro: | ||
| Spatial | ||
| Resolution | 35% [MTF@2lp/mm] | 35% [MTF@2lp/mm] |
| CXDI-Elite: | CXDI-Elite: | |
| 45% [MTF@2lp/mm] | ||
| CXDI-702C Wireless: | 45% [MTF@2lp/mm] | |
| CXDI-702C Wireless: | ||
| 58% [@0.5 lp/mm, 1 mR] | 58% [@0.5 lp/mm, 1 mR] | |
| CXDI-402C Wireless: | ||
| 58% [@0.5 lp/mm, 3.5 uGy] | CXDI-402C Wireless: | |
| 58% [@0.5 lp/mm, 3.5 uGy] | ||
| DQE | CXDI-710C Wireless, CXDI-810C Wireless, and CXDI- | |
| 410C Wireless: | ||
| 60% [@0 lp/mm, 4 uGy] | CXDI-710C Wireless, CXDI-810C Wireless, and CXDI- | |
| 410C Wireless: | ||
| 60% [@0 lp/mm, 4 uGy] | ||
| CXDI-Pro: | CXDI-Pro: | |
| 58% [@0.5 lp/mm, 3.5 uGy] | 58% [@0.5 lp/mm, 3.5 uGy] | |
| CXDI-Elite: | CXDI-Elite: | |
| 67% [@0.5 lp/mm, 3.5 uGy] | 67% [@0.5 lp/mm, 3.5 uGy] | |
| CXDI-702C Wireless and CXDI-402C Wireless IP54 | ||
| CXDI-710C Wireless, CXDI-810C Wireless, and CXDI- | ||
| 410C Wireless: | CXDI-702C Wireless and CXDI-402C Wireless IP54 | |
| CXDI-710C Wireless, CXDI-810C Wireless, and CXDI- | ||
| 410C Wireless | ||
| IP Level | IPX7 | IPX7 |
| CXDI-Pro: | CXDI-Pro: | |
| IP55 | IP55 | |
| CXDI-Elite: | CXDI-Elite: | |
| IP57 | IP57 | |
| CXDI-702C Wireless, CXDI-402C Wireless, CXDI-710C | ||
| Wireless, CXDI-810C Wireless, and CXDI-410C Wireless: | CXDI-702C Wireless, CXDI-402C Wireless, CXDI-710C | |
| Wireless, CXDI-810C Wireless, and CXDI-410C Wireless: | ||
| Wireless | ||
| Communication | IEEE 802.11n | |
| 2.4GHz/5GHz | IEEE 802.11n | |
| 2.4GHz/5GHz | ||
| CXDI-Pro and CXDI-Elite: | CXDI-Pro and CXDI-Elite: | |
| IEEE 802.11a/b/g/n/ac | IEEE 802.11a/b/g/n/ac | |
| 2.4GHz/5GHz | ||
| Bluetooth Low Energy | 2.4GHz/5GHz | |
| Bluetooth Low Energy | ||
| CXDI-702C Wireless, CXDI-402C Wireless, and CXDI-Pro: | CXDI-702C Wireless, CXDI-402C Wireless, and CXDI-Pro: | |
| Standard Synchronization Mode and | ||
| Non Generator Connection Mode | Standard Synchronization Mode and | |
| Non Generator Connection Mode | ||
| CXDI-710C Wireless, CXDI-810C Wireless, and CXDI- | ||
| 410C Wireless: | CXDI-710C Wireless, CXDI-810C Wireless, and CXDI- | |
| 410C Wireless: | ||
| Photographing | ||
| Mode | Standard Synchronization Mode, | |
| Non Generator Connection Mode, and Standalone Mode | Standard Synchronization Mode, | |
| Non Generator Connection Mode, and Standalone Mode | ||
| CXDI-Elite: | CXDI-Elite: | |
| Standard Synchronization Mode, | ||
| Standard Synchronization Mode with Built in AEC | ||
| Assistance, | ||
| Non Generator Connection Mode, and | ||
| Standalone Mode | Standard Synchronization Mode, | |
| Standard Synchronization Mode with Built in AEC | ||
| Assistance, | ||
| Non Generator Connection Mode, and | ||
| Standalone Mode |
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510(k) Summary
K230175
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Image /page/6/Picture/0 description: The image shows the word "Canon" in red, bold letters. The font is sans-serif and the letters are closely spaced together. The word is horizontally oriented and centered in the image. The background is white.
510(k) Summary
K230175
The fundamental scientific technology of the CXDI-CS01 has not been modified. Summary of The major change is the addition of new detectors and component. Non-Clinical/ Test Data: Evaluation of the addition of the new detectors confirmed that the change did not impact the conformance of CXDI-CS01 with the U.S. Performance Standard for radiographic equipment and relevant voluntary safety standards for Electrical safety and Electromagnetic Compatibility testing, specifically IEC standards 60601-1, 60601-1-2, 60601-1-3, 60601-1-6, 60601-2-54, 62220-1, 62304, and 62366. The design control activities and biocompatibility evaluation successfully demonstrated that the modifications to the predicate device raise no new questions regarding either safety or effectiveness. Clinical testing is not necessary for the current submission, based on the minor differences from the predicate device. Adequate detector bench testing should be sufficient to demonstrate that the subject detector, CXDI-CS01, works as intended. Therefore, the verification/validation activities conducted support a determination of substantial equivalence for the CXDI-CS01. 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, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", Radio Frequency Wireless Technology in Medical Devices, and Pediatric Information for X-ray Imaging Device Premarket Notifications. Conclusion: Canon Inc. considers the DIGITAL RADIOGRAPHY CXDI-CS01 device 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.