DIGITAL RADIOGRAPHY CXDI-60C

K091545 · Canon, Inc. · MQB · Jun 15, 2009 · Radiology

Device Facts

• Record ID: K091545
• Device Name: DIGITAL RADIOGRAPHY CXDI-60C
• Applicant: Canon, Inc.
• Product Code: MQB · Radiology
• Decision Date: Jun 15, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1680
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

DIGITAL RADIOGRAPHY CXDI-60C 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. This device is not intended for mammography applications.

Device Story

Digital Radiography CXDI-60C is a solid-state X-ray imager with a 23x28cm imaging area. Device intercepts X-ray photons; scintillator (Cesium Iodide) emits visible light; light illuminates amorphous silicon photo-detector array; array generates electrical signals. Signals converted to digital values; images displayed on monitors for clinician review. Used in clinical settings for general purpose diagnostic radiography. CsI scintillator provides higher X-ray absorption and improved DQE compared to GOS-based predecessors, allowing for lower X-ray dosage. Device replaces film/screen systems; facilitates digital workflow.

Clinical Evidence

Bench testing only. Performance data compared DQE and X-ray dosage requirements against predicate CXDI-60G, demonstrating improved DQE and reduced dosage requirements for the CXDI-60C.

Technological Characteristics

Solid-state X-ray imager; 23x28cm imaging area. Sensing means: amorphous silicon array. Scintillator: Cesium Iodide (CsI). Connectivity: digital output to display monitors. Dimensions: 344x380x22.5mm; Weight: 2.5kg.

Indications for Use

Indicated for digital image capture in general purpose diagnostic radiographic procedures, replacing conventional film/screen systems. Not indicated for mammography.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Canon CXDI-60G (K081648)
• Canon CXDI-50C (K060433)

Submission Summary (Full Text)

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K09/5YS

## Section 10: Summary

# 510(k) Summary

## Prepared:

.

#### April 22, 2009

JUN 1 5 2009

#### Submitter:

Company Name: Canon USA, Inc. (U.S. agent for Canon Inc.) Company Address: One Canon Plaza Lake Success, NY 11042 Contact Person: Ms. Sheila Driscoll Phone Number: (૨1૯) 358-2602 Fax Number: [phone]

#### Proposed Device:

Reason For 510(k): New Model Manufacturer: Canon Inc. Trade Name: Canon Model Name: CXDI-60C Classification Name: MQB, Solid State X-ray Imager FDA 510(k) #: To be assigned

#### Predicate Device:

Manufacturer: Canon Inc. Trade Name: Canon Model Name: CXDI-60G Classification Name: MQB, Solid State X-ray Imager FDA 510(k) #: K081648

#### Predicate Device:

| Manufacturer: | Canon Inc. |
|----------------------|-------------------------------|
| Trade Name: | Canon |
| Model Name: | CXDI-50C |
| Classification Name: | MQB, Solid State X-ray Imager |
| FDA 510(k) #: | K060433 |

## Description of Device:

The DIGITAL RADIOGRAPHY CXDI-60C is a solid state x-ray imager which has 23x28cm imaging area.

The DIGITAL RADIOGRAPHY CXDI-60C intercepts x-ray photons and the scintillator of the CXDI-60C emits visible spectrum photons that illuminate an array of photo-detectors that create an electrical signals.

After the electrical signals are generated, it is converted to digital value, and the images will be displayed on monitors.

Intended Use: DIGITAL RADIOGRAPHY CXDI-60C 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.

This device is not intended for mammography applications.

Comparison to Predicate: CXDI-60C's intended use is the same as that of CXDI-60G and CXDI-50C.

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### Section 10: Summary

However, the differences in the material for fluorescent screen of CXDI-60G are as follows:

Both the CXDI-60C and the CXDI-60G use the same amorphous silicon alley as the sensing means, however, the CXDI-60C uses the different material for fluorescent screen which is deposited on the amorphous silicon array with from the CXDI-60G The CXDI-60C uses CsI (Cesium Iodide) while CXDI-60G uses GOS (Gadolium Oxy-Sulfide). Because of CsI which provides high x-ray absorption as fluorescent screen, CXDI-60C delivers diagnostic images with the x-ray dosage less than that required by CXDI-60G and CXDI-60C's DQE approximately doubles compared to CXDI-60G

Also, the differences in the external dimensions and the weight of CXDI-50C are as follows:

· The external dimensions of CXDI-50C is changed from 491x477x23mm to 344x380x22.5mm.

· The weight of CXDI-55G is changed from 4.8Kg to 2.5Kg.

Conclusion: The Performance Data demonstrate that CXDI-60C is as safe and effective as CXDI-60G Based on the information in this submission, similarity to the predicate device (Digital Radiography CXDI-60G and CXDI-50C), and the results of our design control activities and non-clinical testing, it is the opinion of Canon Inc. that the DIGITAL RADIOGRAPHY CXDI-60C described in this submission is substantially equivalent to the predicate device.

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo includes the department's name in blue text. To the left of the text is a symbol that includes three human silhouettes.

Public Health Service

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

Canon USA. Inc. % Mr. Jeff D. Rongero Third Party Reviewer-Senior Project Engineer Underwriters Laboratories, Inc. 12 Laboratory Drive Research Triangle Park, NC 27709

AUG 23 2013

Re: K091545

Trade/Device Name: CXDI-60C Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: May 26. 2009 Received: May 27, 2009

Dear Mr. Rongero:

This letter corrects our substantially equivalent letter of June 15, 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. 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 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 (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 whilication. 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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

Janine M. Morris 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 Statement

KC91545 510(K)Number(if known): .

Device Name: CXDI-60C

Indications for Use:

DIGITAL RADIOGRAPHY CXDI-60C 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.

This device is not intended for mammography applications.

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

Over-The-Counter Use (Part 21 CFR 801 Subpart C)

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

## Concurrence of CDRH, Office of Device Evaluation(ODE)

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