DIGITAL RADIOGRAPHY MODEL CXDI-55G

K091435 · Canon, Inc. · MQB · May 29, 2009 · Radiology

Device Facts

• Record ID: K091435
• Device Name: DIGITAL RADIOGRAPHY MODEL CXDI-55G
• Applicant: Canon, Inc.
• Product Code: MQB · Radiology
• Decision Date: May 29, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1680
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

DIGITAL RADIOGRAPHY CXDI-55G 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

Solid state x-ray imager; 35x43cm imaging area. Intercepts x-ray photons via scintillator; emits visible light to photo-detector array; converts light to electrical signals; digitizes signals for monitor display. Used in clinical settings for general radiography. Replaces film/screen systems; provides digital images for physician review to support diagnostic decision-making.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Solid state x-ray imager; scintillator-based photon conversion; photo-detector array; 35x43cm active area. Dimensions: 480x481x15mm; Weight: 3.4kg.

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-50G (K031447)

Submission Summary (Full Text)

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K091435 Page 1 of 1

# Section 10: Summary 510(k) Summary

#### Prepared:

April 6, 2009

MAY 2 9 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: [phone] Fax Number: [phone]

### Proposed Device:

Reason For 510(k): New Model Manufacturer: Canon Inc. Trade Name: Canon Model Name: CXDI-55G 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-50G |
| Classification Name: | 90MQB, Solid State X-ray Imager |
| FDA 510(k) #: | K031447 |

#### Description of Device:

The DIGITAL RADIOGRAPHY CXDI-55G is a solid state x-ray imager which has 35x 43cm imaging area.

The DIGITAL RADIOGRAPHY CXDI-55G intercepts x-ray photons and the scintillator of the CXDI-55G emits visible spectrum photons that illuminate an array of photo-detectors that create an clectrical 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-55G 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-55G's intended use is the same as that of CXDI-50G However, the differences in the external dimensions and the weight are as follows:

> The External dimensions of CXDI-55G is changed from 491x 477x 23mm to 480x 481x 15mm. And the weight of CXDI-55G is changed from 4.8Kg to 3.4Kg.

Conclusion: The Performance Data demonstrate that CXDI-55G is as safe and effective as CXDI-50G Based on the information in this submission, similarity to the predicate device (Digital Radiography CXDI-50G), and the results of our design control activities and non-clinical testing, it is the opinion of Canon Inc. that the DIGITAL RADIOGRAPHY CXD1-55G described in this submission is substantially equivalent to the predicate device.

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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 2 3 2013

Re: K091435

Trade/Device Name: CXDI-55G Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MOB Dated: May 12, 2009 Received: May 14. 2009

Dear Mr. Rongero:

This letter corrects our substantially equivalent letter of May 29, 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 of

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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 [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

091435

510(K)Number(if known):

Device Name: CXDI-55G

Indications for Use:

DIGITAL RADIOGRAPHY CXD1-55G 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 proceduros.

This device is not intended for mammography applications.

Prescription Use (Part 21 CFR 801 Subpart D)

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

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

OR

Concurrence of CDRH, Office of Device Evaluation(ODE)

Arvil M. Dhaz
(Division Sign-On)

Division of Renroductive, Auchminal and Radiological Devices 510(k) Number

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