CANON DIGITAL RADIOGRAPHY CXDI-40C provides digital image capture for conventional film/screen radiographic examinations. The device is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures.

Device Description

The Canon digital radiography CXDI-40C is used to directly capture and convert conventional projection X-ray images to digital images. A sub-sampled image can be displayed on a preview monitor for viewing. The diagnostic image can be transmitted through a DICOM compatible digital network for printing. The device provides digital image capture for conventional film/screen radiographic examinations. The CXDI-40C uses CsI (Cesium Iodide) as the fluorescent screen deposited on the amorphous silicon array, while the predicate CXDI-40G uses GOS (Gadolium Oxy-Sulfide). The CXDI-40C delivers diagnostic images with approximately half the xray dosage required by CXDI-40G and CXDI-40C's DQE approximately doubles compared to CXDI-40G. The CXDI-40C's imaging size, number of pixels and pixel pitch are the same as those of CXDI-40G. CXDI-40C operates in conjunction with an upright stand, table, and universal stand. CXDI-40C's housing size and shape are almost as same as those of CXDI-40G. A Control PC is required to operate the CXDI-40C.

AI/ML Overview

The provided text is a 510(k) summary for a medical device (Canon CXDI-40C digital radiography system) seeking clearance from the FDA. It declares substantial equivalence to a predicate device (Canon CXDI-40G).

Here's an analysis of the acceptance criteria and study information, based on the provided text:

Key Takeaway: The provided 510(k) summary does not contain information about acceptance criteria or specific studies that prove the device meets those criteria in the way typically required for AI/CAD-based devices. This document is from 2003 and for a digital radiography system replacing film/screen, not a system with advanced analytics or AI. The FDA clearance is based on substantial equivalence to an existing device, primarily focusing on hardware differences (fluorescent screen material) and the impact on image quality (DQE, dosage).

Therefore, many of the requested fields below will be marked as "Not Applicable" or "Not Provided" because the nature of this submission is different from one for an AI/CAD device.

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Primary Goal: Substantial Equivalence to predicate device (Canon CXDI-40G)	The submission states, "Based on the information in this submission, similarity to the predicate devices (the Canon digital radiography the CXDI-40G), and the results of our design control activities, it is our opinion that the Canon digital radiography CXDI-40C described in this submission is substantially equivalent to the predicate devices." The FDA concurred with this determination.
Image Quality:	CXDI-40C delivers diagnostic images with approximately half the x-ray dosage required by CXDI-40G.
Image Quality:	CXDI-40C's DQE approximately doubles compared to CXDI-40G.
Imaging System Equivalence:	Same amorphous silicon array, imaging size, number of pixels, and pixel pitch as CXDI-40G. Operates in conjunction with the same accessory equipment (upright stand, table, universal stand). Housing size and shape are almost the same.
Intended Use Equivalence:	Provides digital image capture for conventional film/screen radiographic examinations, intended to replace radiographic film/screen systems in all general purpose diagnostic procedures – same as predicate.

Study Details

Sample sized used for the test set and the data provenance:
- Not Provided. The document relies on similarity to a predicate device and improved technical specifications (like DQE and reduced dosage), rather than a clinical test set with patient data for performance evaluation in the context of an AI/CAD system.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable / Not Provided. This type of evaluation (expert-established ground truth) is typical for AI/CAD devices, not for a fundamental digital X-ray capture system like this, where the primary evaluation is technical equivalence and imaging characteristics.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable / Not Provided.
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:
- Not Applicable / Not Done. This is not an AI-assisted device. The primary comparison is between the proposed device and a predicate digital radiography device, focusing on hardware and image acquisition characteristics.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable / Not Done. This device is a digital X-ray capture system, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable / Not Provided. The "ground truth" in this context would be the successful capture of diagnostic-quality X-ray images, as demonstrated by technical metrics (DQE, dosage) and clinical history/usage of the predicate device. It's not about disease detection performance.
The sample size for the training set:
- Not Applicable / Not Provided. This is a hardware device submission, not an AI model submission. There is no concept of a "training set" for the device itself in this context.
How the ground truth for the training set was established:
- Not Applicable / Not Provided.

Summary

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Section 10: Summary Koz 1633 510(k) Summary

Prepared:

April 8, 2003

Submitter:

Company Name: Company Address:

Contact Person: Phone Number: Fax Number:

Canon USA, Inc. (U.S. agent for Canon Inc.) One Canon Plaza Lake Success, NY 11042 Ms. Sheila Driscoll (516) 328-5602 (516) 328-5169

Proposed Device:

Reason For 510(k): Manufacturer: Trade Name: Model Name: Classification Name: Regulation Number: FDA 510(k) #:

New Model Canon Inc. Canon CXDI-40C צו יורק // CXDI-40C MQB, Solid State X-ray Imager 892.1630 To be assigned

Predicate Device:

Manufacturer: Trade Name: Model Name: Classification Name: Regulation Number: FDA 510(k) #:

Canon Inc. Canon CXDI-40G V 6, V MQB, Solid State X-ray Imager 892.1630 K023750

Description Of Device:

The Canon digital radiography CXDI-40C is different from CXDI-40G in the following respect.

Both the CXDI-40C and the CXDI-40G use the same amorphous silicon alley as the . sensing means, however, the CXDI-40C uses the different material for fluorescent screen which is deposited on the amorphous silicon array with from the CXDL-40G. The CXDI-40C uses CsI (Cesium Iodide) while CXDI-40G uses GOS (Gadolium Oxy-Sulfide). Because of CsI which provides high x-ray absorption as fluorescent screen, CXDI-40C delivers diagnostic images with approximately half the xray dosage required by CXDI-40G and CXDI-40C's DQE approximately doubles compared to CXDI-40G.
Since the same amorphous silicon array is used, the CXDI-40C's imaging size, number of pixels and pixel pitch are the same as those of CXDI-40C as well as CXDI-40G operates in conjunction with an upright stand, table, and universal stand. CXDI-40C's housing size and shape are almost as same as those of CXDI-40G.

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KO31633

Section 10: Summary

Control PC is required to operate the CXDI-40C as well as the predicate devices.

Intended Use:

Canon digital radiography CXDI-40C provides digital image capture for conventional film/screen radiographic examinations. The device is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures.

Based on the information in this submission, similarity to the predicate devices (the Canon digital radiography the CXDI-40G), and the results of our design control activities, it is our opinion that the Canon digital radiography CXDI-40C described in this submission is substantially equivalent to the predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 1 2003

Canon, Inc. % Ms. Susan Gill Senior Project Engineer Underwriters Laboratories, Inc. 12 Laboratory Drive P.O. Box 13995 Research Triangle Park, NC 27709-3995

Re: K031633 Trade/Device Name: Digital Radiography Model CXDI-40C Regulation Number: 21 CFR 892.1630 Regulation Name: Solid state x-ray imaging system Regulatory Class: II Product Code: 90 MQB Dated: May 23, 2003 Received: May 27, 2003

Dear Ms. Gill:

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. 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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2

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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

8xxx. 1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours.

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Section 3: Statement

Indications Statement

Page | of

510(K)Number(if known): K031632

-40 C V 6.0 Device Name:

Indications for Use:

CANON DIGITAL RADIOGRAPHY CXDI-40C provides digital image capture for conventional film/screen radiographic examinations.

The device is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures.

EASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHERT PAGE IF

Concurrence of CDRH, Office of Device Evaluation(ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

David A. Seppam

3-2

Regulation Number and Section

§ 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.