The CXDI-50RF is indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures. It is also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. It is intended to replace fluoroscopic images obtained through image intensifier technology. Not intended for mammography applications.

Device Description

The Canon Dynamic/Static DR CXDI-50RF is a portable digital radiography that can take images of any part of the body. It directly converts the X-ray images captured by the LANMIT (Large Area New MIS Sensor and TFT) sensor into a high-resolution digital images. The instrument is suited for use inside a patient environment. This unit converts the X-rays into digital signals. The unit can acquire still and moving images.

AI/ML Overview

The Canon Dynamic/Static DR Fluoroscopic Digital X-Ray Receptor Panel (Model CXDI-50RF) is indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic, and interventional procedures, as well as for cardiology, diagnostic, and interventional procedures. It is intended to replace fluoroscopic images obtained through image intensifier technology and is not intended for mammography applications.

Here's an analysis of the provided information regarding acceptance criteria and the study:

Acceptance Criteria Category	Reported Device Performance
Technological Characteristics	"Comparison with the predicate shows the technological characteristics of the CXDI-50RF are equal to or better than the predicate device. The units are functionally identical."
Safety and Effectiveness	"Tests were performed on the device which demonstrated that the device is safe and effective, performs comparably to and is substantially equivalent to the predicate device. Tests include: Performance testing and Software Validation. Electrical safety and Electromagnetic Compatibility testing has been performed. The unit complies with the US Performance Standard for radiographic equipment."

Details of the Study:

The provided 510(k) summary (K092439) for the Canon Dynamic/Static DR Model CXDI-50RF Fluoroscopic Digital X-Ray Receptor Panel primarily relies on showing substantial equivalence to predicate devices rather than a detailed clinical performance study with specific metrics like sensitivity, specificity, or AUC based on expert reads.

Here's what can be inferred from the document:

Sample size used for the test set and the data provenance:
- The document does not specify a sample size for a test set in the context of an accuracy or performance study involving image interpretation.
- The data provenance is not described in terms of country of origin or whether it was retrospective or prospective.
- The "Performance Testing/Data" section mentions "Tests were performed on the device," but these tests appear to be primarily technical and safety assessments (e.g., electrical safety, EMC, software validation) and comparative assessments against predicate devices' technological characteristics, not a clinical study on diagnostic accuracy.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided. The submission focuses on technical equivalence and safety, not on evaluating human reader performance with the device against a ground truth established by experts.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This information is not provided, as there is no described clinical test set requiring expert adjudication for diagnostic accuracy.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. This submission predates the widespread regulatory requirement for such studies for AI-powered devices. The device described is a digital X-ray receptor panel, an imaging hardware component, not an AI diagnostic algorithm. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No, a standalone algorithm performance study was not done. The device is an image acquisition component, not a diagnostic algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- This information is not provided for a clinical diagnostic performance study. The "ground truth" implied in the submission relates to technical specifications, safety standards, and functional equivalence to predicate devices.
The sample size for the training set:
- There is no mention of a training set in the context of machine learning or AI models. The device is a hardware component for imaging, not a software algorithm that requires a training set.
How the ground truth for the training set was established:
- This information is not applicable as there is no training set for an AI/machine learning model described.

Summary

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K092439

510(k) SUMMARY

NOV 3 0 2009

Image /page/0/Picture/3 description: The image shows the logo for Virtual Imaging, a Canon USA company. The logo features a stylized "V" shape on the left, followed by the words "VIRTUAL IMAGING" in bold, sans-serif font. Below the logo is the text "A CANON USA Company" in a smaller font size.

Image /page/0/Picture/4 description: The image shows the word "Canon" in a stylized font. The letters are outlined and filled with a pattern that resembles a mosaic or a textured surface. The overall design gives the word a three-dimensional appearance.

720 S. Powerline Road, Suite E Deerfield Beach, FL 33442 954-428-6191 {Office}

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Page 1 of 2, 510(k) Summary: Canon Dynamic/Static DR Fluoroscopic Digital X-Ray Receptor Panel

Model CXDI-50RF

Date Prepared	July 30, 2009
Summary prepared by:	Chris Duca, Chief Operating Officer
Device Name	Canon Dynamic/Static DRFluoroscopic Digital X-Ray Receptor Panel
Trade Name	Model CXDI-50RF
Common Name	Fluoroscopic Digital X-Ray Receptor Panel
Classification	Class: IIProduct Code: MQL OWB, JAA, I2IRegulation: 21 CFR § 892.1650
Identification ofPredicate Devices andSummary of SubstantialEquivalence	Siemens AXIOM Luminos dRF, K062623GE Innova 4100 K023178/K091658Canon CXDI-50C K060433
Device Description	The Canon Dynamic/Static DR CXDI-50RF is a portable digitalradiography that can take images of any part of the body.It directly converts the X-ray images captured by the LANMIT(Large Area New MIS Sensor and TFT) sensor into a high-resolutiondigital images. The instrument is suited for use inside a patientenvironment. This unit converts the X-rays into digital signals. Theunit can acquire still and moving images.

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Page 2 of 2, 510(k) Summary: Canon Dynamic/Static DR Fluoroscopic Digital X-Ray Receptor Panel Model CXDI-50RF

Intended Use and Indications	The CXDI-50RF is indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures. It is also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. It is intended to replace fluoroscopic images obtained through image intensifier technology. Not intended for mammography applications.
Technological Characteristics and Substantial Equivalence	Comparison with the predicate shows the technological characteristics of the CXDI-50RF are equal to or better than the predicate device. The units are functionally identical.
Performance Testing/Data	Tests were performed on the device which demonstrated that the device is safe and effective, performs comparably to and is substantially equivalent to the predicate device.Tests include: Performance testing and Software Validation. Electrical safety and Electromagnetic Compatibility testing has been performed. The unit complies with the US Performance Standard for radiographic equipment.

Intended Use and Indications

Technological Characteristics and Substantial Equivalence

Comparison with the predicate shows the technological characteristics of the CXDI-50RF are equal to or better than the predicate device. The units are functionally identical.

Performance Testing/Data

Tests were performed on the device which demonstrated that the device is safe and effective, performs comparably to and is substantially equivalent to the predicate device.Tests include: Performance testing and Software Validation. Electrical safety and Electromagnetic Compatibility testing has been performed. The unit complies with the US Performance Standard for radiographic equipment.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Virtual Imaging, Inc. % Mr. Daniel Kamm, P.E. Submission Correspondent Kamm & Associates 8726 Ferrara Ct. NAPLES FL 34114

JUL 3 0 2012

Re: K092439

Trade/Device Name: Canon Dynamic/Static DR Model CXDI-50RF Fluoroscopic Digital X-Ray Receptor Panel

Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB, JAA and IZI Dated: October 28, 2009 Received: November 3, 2009

Dear Mr. Kamm:

This letter corrects our substantially equivalent letter of November 30. 2009.

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. Drue, 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. 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.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21. Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809): medical device reporting of

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Page 2

medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

Janine M. Morris

Janine M. Mdrri Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

510(k) Number (if known): K092439 Device Name: Canon Dynamic/Static DR Model CXDI-50RF Fluoroscopic Digital X-Ray Receptor Panel

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign-Off

Page 1 of 1

ductive, Abdominal

10(k) Number

Regulation Number and Section

§ 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.