DIGITAL RADIOGRAPHY

K112309 · Canon Inc. -Medical Equipment Group · MQB · Sep 2, 2011 · Radiology

Device Facts

• Record ID: K112309
• Device Name: DIGITAL RADIOGRAPHY
• Applicant: Canon Inc. -Medical Equipment Group
• Product Code: MQB · Radiology
• Decision Date: Sep 2, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1680
• Device Class: Class 2

Intended Use

The DIGITAL RADIOGRAPHY CXDI-80C Wireless and CXDI-80G Wireless provide digital image capture for conventional film/screen radiographic examinations. These devices are intended to replace radiographic film/screen systems in all general purpose diagnostic procedures. These devices are not intended for mammography applications.

Device Story

Solid state X-ray imagers (27x35cm area) capture X-ray photons; scintillator converts photons to visible light; photo-detector array generates electrical signals; signals converted to digital values; images displayed on monitors. Data transmitted via wired or wireless connection to operator console. Used in clinical settings by healthcare professionals for general diagnostic radiography. Replaces film/screen systems to provide digital images for clinical decision-making.

Clinical Evidence

Bench testing only. Electrical safety, electromagnetic compatibility, and performance testing demonstrated safety and effectiveness equivalent to predicate devices.

Technological Characteristics

Amorphous silicon array; 27x35cm imaging area; scintillator-based X-ray detection; wired/wireless connectivity; digital image output.

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

• DIGITAL RADIOGRAPHY CXDI-401G (K103591)
• DIGITAL RADIOGRAPHY CXDI-70C Wireless (K102012)

Submission Summary (Full Text)

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Section 5: 510(k) Summary

# 510(k) Summarv

SEP - 2 2011

### Prepared:

August 10, 2011

New Model

Canon

Submitter/Holder:

Company Name: Company Address:

> Contact Person: Phone Number: Fax Number:

CANON INC. 30-2 Shimomaruko 3-chome, Ohta-ku Tokyo 146-8501, Japan Naoyasu Asaka 81-3-3758-2111 81-3-5482-3960

Proposed Device:

Reason For 510(k): Trade Name: Model Name:

Classification Name: FDA 510(k) #:

### Predicate Device:

Trade Name: Canon

FDA 510(k) #/Model Name

Classification Name:

DIGITAL RADIOGRAPHY CXDI-80C Wireless DIGITAL RADIOGRAPHY CXDI-80G Wireless 90MQB, Solid State X-ray Imager To be assigned

FDA 510(k) #/Model Name: K103591/ DIGITAL RADIOGRAPHY CXDI-401G K102012/ DIGITAL RADIOGRAPHY CXDI-70C Wireless 90MQB, Solid State X-ray Imager

## Description of Device:

The DIGITAL RADIOGRAPHY CXDI-80C Wireless and CXD1-80G Wireless are solid state x-ray imagers which have 27x35cm imaging area.

The DIGITAL RADIOGRAPHY CXDI-80C/80G Wireless intercept x-ray photons and the scintillator of the CXDI-80C/80G Wireless emit visible spectrum phonomy photons and the array of photo-detectors that create electrical signals.

After the electrical signals are generated, it is converted to digital value, and the images will be displayed on monitors. The digital value can be communicated to the operator conselver wia wiring connection or wireless.

### Intended Use:

The DIGITAL RADIOGRAPHY CXDI-80C Wireless and CXDI-80G Wireless provide digital image capture for conventional film/screen radiographic examinations. These devices are intended to replace radiographic film/screen systems in all general purpose diagnostic procedures. These devices are not intended for mammography applications.

## Comparison to Predicate:

The amorphous silicon array specifications of CXDI-80C Wireless and CXDI-80G Wireless, imaging principle and intended use are the same as those of the predicate devices, (CXDI-70C Wireless and CXDI-401G).

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K112309
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Section 5: 510(k) Summary

## Performance testing:

The Electrical safety, Electromagnetic compatibility and other performance testings were performed on these devices which demonstrated that these devices are safe and effective, and are equivalent to the predicate devices.

## Conclusion:

The Performance Data demonstrate that CXDI-80C Wireless and CXDI-80G Wireless are as safe and effective as the predicate devices (CXDI-70C Wireless and CXDI-401G). Based on the information in this submission, similarity to the predicate devices, and the esults of Our design Control activities and non-clinical testing, it is our opinion that the DIGITAL RADIOGRAPHY CXDI-80C Wireless and CXDI-80G Wireless described in this submission are substantially equivalent to the predicate devices.

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo consists of a blue emblem on the left and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" on the right. The emblem features a stylized human figure with outstretched arms, and the text is written in a clear, sans-serif font.

Public Health Service

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

Mr. Naoyasu Asaka Staff manager Canon Inc. 30-2 Shimomaruko 3-Chrome OHTA-KU TOKYO 146-8501 JAPAN

AUG 2 3 2013

Re: K112309

Trade/Device Name: Canon/Digital Radiology, CXDI-80C Wireless, Canon/Digital Radiology, CXDI-80G Wireless Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MOB Dated: August 10, 2011 Received: August 11, 2011

Dear Mr. Asaka:

This letter corrects our substantially equivalent letter of September 13, 2011.

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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medical device-related adverse events) (21 CFR 803); and good manufacturing practice mouited device-related ad retos ovelity systems (QS) regulation (21 CFR Part 820). This letter requirences as bet for in are quality - device as described in your Section 510(k) premarket witi anow you to ocgin markoming your views and equivalence of your device to a legally marketed noutication. The FDT intention 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 If you desire specific davice 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 under the MDA regulation (21 Of RT at 007) promo goodem/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 I ou may obain other general 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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K112309

# Indications for Use

K112309 510(K) Number (if known):.

Device Name: CXDI-80C Wireless and CXD1-80G Wireless

Indications for Use:

ﻟﺴﻌ

DIGITAL RADIOGRAPHY CXDI-80C Wireless and CXDI-80G Wireless provide digital image capture for conventional film/screen radiographic examinations.

These devices are intended to replace radiographic film/screen systems in all general purpose diagnostic procedures.

These devices are not intended for mammography applications.

Prescription Use × (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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Mary S Patil

Office In Vitro Diagnostic Device Evaluation and Safety
Division of Chemistry and Toxicology Devices

610k K112309