(269 days)
Not Found
No
The document describes standard digital radiography technology and image processing, with no mention of AI, ML, or related concepts.
No
The device is described as an X-ray imager used for generating diagnostic images, not for treating any condition.
Yes
The device's intended use explicitly states it is for "general purpose diagnostic procedures" and for generating "fluoroscopic images, when integrated into the X-ray diagnostic systems, to replace the spot-film devices and the X-ray image intensifiers." These functions clearly place it in the diagnostic category.
No
The device description clearly states it is a "solid state X-ray imager" and describes hardware components like a scintillator, photodetectors, and the process of converting electrical signals to digital values. While it includes software for image conversion and display, it is fundamentally a hardware device with integrated software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to generate radiographic and fluoroscopic images of human anatomy for general diagnostic procedures. This involves imaging the internal structure of the body using X-rays.
- Device Description: The device is an X-ray imager that captures X-ray photons and converts them into digital images.
- Nature of IVD: In vitro diagnostics are tests performed on samples taken from the human body (such as blood, urine, or tissue) to detect diseases, conditions, or infections.
This device is clearly an in vivo imaging device, meaning it is used to image the inside of a living body directly, rather than analyzing samples taken from the body.
N/A
Intended Use / Indications for Use
DIGITAL RADIOGRAPHY CXDI-RF Wireless B1 is indicated for use in generating radiographic images of human anatomy to replace the radiographic film/screen systems in all general purpose diagnostic procedures. It is also used for generating fluoroscopic images, when integrated into the X-ray diagnostic systems, to replace the spot-film devices and the X-ray image intensifiers.
Not intended for mammography applications.
Product codes
OWB, MQB
Device Description
The proposed CXDI-RF Wireless B1 is a solid state X-ray imager, which is capable of both fluoroscopic and spot radiographic imaging and has a common Thallium-doped Cesium Iodide (CsI:TI) scintillator. The CXDI-RF Wireless B1 will be integrated as a component into the Canon fluoroscopy x-ray system for fluoroscopic and radiographic imaging. The CXDI-RF Wireless B1 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 (CXDI Controller RF version 3.11), and then displayed on the PC/monitors. The PC/monitors used with the CXDI-RF Wireless B1 are not a part of this submission.
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)
No clinical testing was required as non-clinical testing should be sufficient to demonstrate that the DIGITAL RADIOGRAPHY CXDI-RF Wireless B1 works as intended.
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
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. 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). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic 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. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device 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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April 26, 2024
Image /page/0/Picture/1 description: The image contains 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 Inc. % Saori Sawaki Business Manager, Regulatory Consultant Ken Block Consulting LLC 800 E Campbell Road. Suite 202 RICHARDSON, TX 75081
Re: K232298
Trade/Device Name: DIGITAL RADIOGRAPHY CXDI-RF Wireless Bl Regulation Number: 21 CFR 892.1650 Regulation Name: Image-Intensified Fluoroscopic X-Ray System Regulatory Class: Class II Product Code: OWB, MQB Dated: March 26, 2024 Received: March 26, 2024
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
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
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Indications for Use
510(k) Number (if known) K232298
Device Name DIGITAL RADIOGRAPHY CXDI-RF Wireless B1
Indications for Use (Describe)
DIGITAL RADIOGRAPHY CXDI-RF Wireless B1 is indicated for use in generating radiographic images of human anatomy to replace the radiographic film/screen systems in all general purpose diagnostic procedures. It is also used for generating fluoroscopic images, when integrated into the X-ray diagnostic systems, to replace the spot-film devices and the X-ray image intensifiers.
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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3
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.
| Applicant/ Sponsor: | Canon Inc. 9-1 Imaikami-cho Nakahara-ku, Kanagawa 211-8501 JAPAN |
|---|---|
| Contact Person: | Mr. Shigeo Watanabe General Manager TEL: 81-3-3758-2111 FAX: 81-44-739-6695 watanabe.shigeo@mail.canon |
| Date Prepared: | March 26, 2024 |
| Subject Device | Manufacturer: Canon Inc. |
| Trade Name: DIGITAL RADIOGRAPHY CXDI-RF Wireless B1 | |
| Common Name: Solid State X-Ray Imager (Flat Panel/Digital Imager) | |
| Classification Name: Image-intensified fluoroscopic x-ray system | |
| Classification Product Code: OWB | |
| Subsequent Product Codes: MQB | |
| Regulation: 21 CFR 892.1650, Image-intensified fluoroscopic x-ray system | |
| Class: II | |
| Predicate Device: | Clearance: K171194, 05/24/2017 |
| Manufacturer: Canon Inc. | |
| Trade Name: AS-10/CXDI-401RF | |
| Common Name: Solid State X-Ray Imager (Flat Panel/Digital Imager) | |
| Classification Name: Image-intensified fluoroscopic x-ray system | |
| Classification Product Code: OWB | |
| Subsequent Product Codes: MQB, JAA | |
| Regulation: 21 CFR 892.1650, Image-intensified fluoroscopic x-ray system | |
| Class: II |
Device Description:
The proposed CXDI-RF Wireless B1 is a solid state X-ray imager, which is capable of both fluoroscopic and spot radiographic imaging and has a common Thallium-doped Cesium Iodide (CsI:TI) scintillator. The CXDI-RF Wireless B1 will be integrated as a component into the Canon fluoroscopy x-ray system for fluoroscopic and radiographic imaging. The CXDI-RF Wireless B1 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 (CXDI Controller RF version 3.11), and then displayed on the PC/monitors. The PC/monitors used with the CXDI-RF Wireless B1 are not a part of this submission.
Indications for Use:
DIGITAL RADIOGRAPHY CXDI-RF Wireless B1 is indicated for use in generating radiographic images of human anatomy to replace the radiographic film/screen systems in all general purpose diagnostic procedures. It is also used for
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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 stylized. The background is white.
K232298
generating fluoroscopic images, when integrated into the X-ray diagnostic systems, to replace the spot-film devices and the X-ray image intensifiers. Not intended for mammography applications.
Summary of Comparison with the predicate device shows the technological characteristics of the Technological proposed CXDI-RF Wireless B1 are substantially equivalent to the predicate device. Characteristics: The proposed indications for use statement differs slightly in wording from the predicates but does not impact the intended use. Both the proposed and predicate devices are indicated for fluoroscopic and radiographic use. The major differences between the proposed CXDI-RF Wireless B1 and the predicate are differences in the components, the new control software, the new photographing modes, wireless communication, and the decrease in size resulting in less pixels, weight, smaller image area, etc. Those changes were evaluated and verified/validated to support the substantial equivalence and demonstrate these differences raise no new different questions of safety and effectiveness.
| New Device | Predicate Device | |
|---|---|---|
| Trade Name | DIGITAL RADIOGRAPHY CXDI-RF Wireless B1 | AS-10/CXDI-401RF |
| 510(k) | ||
| Submitter | ||
| [Number] | Canon Inc. | |
| [K232298] | Canon Inc. | |
| [K171194] | ||
| Indications for | ||
| Use | DIGITAL RADIOGRAPHY CXDI-RF Wireless B1 | |
| is indicated for use in generating radiographic | ||
| images of human anatomy to replace the | ||
| radiographic film/screen systems in all general | ||
| purpose diagnostic procedures. It is also used for | ||
| generating fluoroscopic images, when integrated | ||
| into the X-ray diagnostic systems, to replace the | ||
| spot-film devices and the X-ray image intensifiers. | ||
| Not intended for mammography applications. | The AS-10 / CXDI-401RF is indicated for use in | |
| generating fluoroscopic and radiographic images of | ||
| human anatomy for angiography, diagnostic, and | ||
| interventional procedures. The device is intended to | ||
| replace spot-film devices. The device is also intended | ||
| to replace fluoroscopic images obtained through image | ||
| intensifier technology. | ||
| Not intended for mammography applications. | ||
| Application | Fluoroscopy and General Radiology | Fluoroscopy and General Radiology |
| Software | CXDI Control Software RF V3.11 | CXDI Control Software V2 |
| Standard | ||
| Components | ||
| Optional | ||
| Components | Detector (Sensor) Unit (AF-B4343W) | |
| Multi Box (MB-01) | ||
| Battery Pack (LB-4A) | ||
| Battery Charger (BC-01, BC-1A) | ||
| Status Indicator (SI-01) | ||
| Ready Indicator (RI-3A) | ||
| Wiring Cable (WC-01) | ||
| XIF Expansion Unit for Radiography (IFU-MB01- | ||
| XIF) | ||
| Expansion Unit for AF-B4343W (IFU-MB01) | ||
| Expansion Unit for CXDI-710/702 Series (IFU- | ||
| MB01-S) | Detector (Sensor) Unit (AS-10 / CXDI-401RF) | |
| Power Box (PB-9) | ||
| Optical Cable (BH7-9753-000, BH7-9754-020) | ||
| Power Supply Cable (BH7-9923-000, BH7-9924-000) | ||
| Grid Unit | ||
| Detector | ||
| Technology | Scintillator and amorphous silicon (a-Si) | Scintillator and amorphous silicon (a-Si) |
| Scintillator | Cesium Iodide doped with Thallium (CsI(Tl)) | Cesium Iodide doped with Thallium (CsI(Tl)) |
| External | ||
| Dimensions | 460 x 460 x 15.5 mm | 469 x 469 x 58 mm |
| Weight | 3.5 ± 0.1 kg | |
| (with Battery) | 13 kg | |
| (Sensor Unit without Cable) |
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Image /page/5/Picture/0 description: The image shows the word "Canon" in red, with a bold, sans-serif font. The letters are closely spaced and appear to be slightly italicized. The overall impression is of a well-known brand logo.
K232298
| New Device | Predicate Device | |
|---|---|---|
| Trade Name | DIGITAL RADIOGRAPHY CXDI-RF Wireless B1 | AS-10/CXDI-401RF |
| Pixel Pitch | 160 x 160 μm | 160 x 160 μm |
| Dynamic Range | Fluoroscopy: 0.02 to 1.9 uGy | |
| Radiography: 0.05 to 25 uG | Fluoroscopy: 0.01 to 1.9 µGy | |
| Radiography: 0.05 to 25 µGy | ||
| Spatial | ||
| Resolution | RQA5 =0.38 | |
| (MTF@2lp/mm) | RQA5 =0.28 | |
| (MTF@2lp/mm) | ||
| DQE | 0.67 | |
| (@ 2 µGy in 0lp/mm) | 0.75 | |
| (@ 1 µGy in Olp/mm) | ||
| Pixels | 2,656 x 2,592 | |
| (Approximately 6.8 million) | 2,688 x 2,688 | |
| (Approximately 7.2 million) | ||
| Imaging Area | ||
| (Detector) | 415 x 425 mm | 430 mm x 430 mm |
| Attenuation | ||
| Equivalent | Max 0.26 mmAl | 0.30 mmAl |
| Binning Mode | 1x1, 2x2, 3x3 | 1x1, 2x2, 3x3 |
| Acquisition | ||
| Mode | Radiography: Up to 15 fps | |
| Fluoroscopy : Up to 30 fps | Radiography: Up to 15 fps | |
| Fluoroscopy : Up to 30 fps | ||
| Cooling | Active air cooling | |
| In tray | Active air cooling | |
| Image | ||
| Processing | Preprocessing | Preprocessing |
| A/D Conversion | 16-bit | 16-bit |
| Grayscale | 65536 grayscales (16-bit) | 65536 grayscales (16-bit) |
| Photographing | ||
| Mode | Standard Synchronization Mode, | |
| Standard Synchronization Mode with Built in AEC | ||
| Assistance | Generator Connection Mode, | |
| Non-Generator Connection Mode | ||
| Wireless | ||
| Communication | IEEE802.11a/b/g/n (2.4 GHz/5GHz) | N/A |
| Sensor Element | ||
| Spacing | 160 μm | 160 μm |
| Fill Factor | 89 % | 85 % |
| Total Element | ||
| Count | 2,656 x 2,592 | 2,688 x 2,688 |
The CXDI-RF Wireless B1 was developed and produced under consideration of all Summary of Non-Clinical/ applicable technical standards, internal specifications, and FDA guidance documents. Test Data: The CXDI-RF Wireless B1 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,
- . Content of Premarket Submissions for Device Software Functions,
- 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.
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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 stylized. The word is written in all capital letters.
K232298
Tests, including verification/validation, were performed on the CXDI-RF Wireless B1 according to the following FDA recognized concensus standards:
- . ISO 10993-1: 2018, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
- . ISO 10993-5: 2009. Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
- . ISO 10993-10:2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
- ISO 10993-12: 2012, Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
- ISO 14971: 2019, Medical devices - Application of risk management to medical devices
- . IEC 62304: 2015. Medical device software - Software life cvcle processes
- . IEC 62366-1: 2020. Medical devices - Part 1: Application of usability engineering to medical devices
- . ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text), Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)
- . IEC 60601-1-2 Edition 4.0 2014-02. Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- . IEC 60601-1-3 Edition 2.1 2013-04, Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
- . IEC 60601-1-6 Edition 3.1 2013-10, Medical Electrical Equipment - Part 1-6: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Usability
- IEC 60601-2-54: 2018, Medical electrical equipment Part 2-54: Particular ● requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopv
The tests successfully demonstrated that the differences from the predicate device raise no new questions regarding either safety or effectiveness and supports a determination of substantial equivalence for the CXDI-RF Wireless B1.
- No clinical testing was required as non-clinical testing should be sufficient to Clinical Testing: demonstrate that the DIGITAL RADIOGRAPHY CXDI-RF Wireless B1 works as intended.
- Conclusion: Canon Inc. considers the DIGITAL RADIOGRAPHY CXDI-RF Wireless B1 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.