DIGITAL RADIOGRAPHY

K102012 · Canon Inc. -Medical Equipment Group · MQB · Aug 17, 2010 · Radiology

Device Facts

• Record ID: K102012
• Device Name: DIGITAL RADIOGRAPHY
• Applicant: Canon Inc. -Medical Equipment Group
• Product Code: MQB · Radiology
• Decision Date: Aug 17, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1680
• Device Class: Class 2

Intended Use

DIGITAL RADIOGRAPHY CXD1-70C Wireless 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 (approx. 35x43cm) captures X-ray photons; scintillator converts X-rays to visible light; photo-detector array converts light to electrical signals; signals digitized for display on operator console. Connectivity via wired or wireless interface. Used in clinical settings for general diagnostic procedures; operated by trained healthcare professionals. Output provides digital radiographic images for clinical review and decision-making, replacing traditional film/screen systems.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Solid state X-ray imager; scintillator-based photon detection; 35x43cm imaging area; wired/wireless connectivity; digital signal conversion.

Indications for Use

Indicated for general purpose diagnostic radiographic examinations in patients requiring conventional film/screen imaging. 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 Inc. CXDI-55C (K091545)
• Canon Inc. CXDI-31 (K003689)

Submission Summary (Full Text)

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Section 10: Summary

K102012

# 510(k) Summary

Tokyo 146-8501, Japan

#### Prepared:

# July 15, 2010

Canon Inc.

Naoyasu Asaka

81-3-3758-2111

81-3-5482-3960

AUG 1 7 2010

#### Submitter/Holder:

Company Name: Company Address:

Contact Person: Phone Number: Fax Number:

#### Proposed Device:

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

New Model Canon Inc. CXDI-70C Wireless 90MQB, Solid State X-ray Imager To be assigned

30-2 Shimomaruko 3-chome, Ohta-ku

## Predicate Device:

Trade Name: Model Name: Classification Name: FDA 510(k) #:

Trade Name: Model Name: Classification Name: FDA 510(k) #:

Canon Inc. CXDI-55C 90MQB, Solid State X-ray Imager K091545

Canon Inc. CXDI-31 90MQB, Solid State X-ray Imager K003689

#### Description of Device:

The DIGITAL RADIOGRAPHY CXDI-70C Wireless is a solid state x-ray imager which has approx. 35x43cm imaging area.

The DIGITAL RADIOGRAPHY CXD1-70C Wireless intercepts x-ray photons and the scintillator of the CXDI-70C Wireless 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. The digital value can be communicated to the operator console via wiring connection or wireless.

#### Intended Use:

DIGITAL RADIOGRAPHY CXD1-70C Wireless 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.

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Section 10: Summary

#### Comparison to Predicate:

The CXDI-70C Wireless's imaging principle and intended use are the same as those of CXDI-55C. Pixel pitch used in CXDI-70C Wireless is different from CXDI-55C, however, most of the specifications are the same or better than CXDI-55C.

## Conclusion:

The Performance Data demonstrate that CXD1-70C Wireless is as safe and effective as the predicate devices (DIGITAL RADIOGRAPHY CXDI-55C and CXDI-31). Based on the information in this submission, similarity to the predicate devices, and the results of our design control activities and non-clinical testing, it is the opinion of Canon Inc. that the DIGITAL RADIOGRAPHY CXDI-70C Wireless described in this substantially equivalent to the predicate devices.

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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, Inc. - Medical Equipment Group % Mr. Koji Kubo. Manager Cosmos Corporation. Tokyo Office 3F 2-17-6 Akebono-cho Tachikawa-shi, Tokyo 190-0012 JAPAN

Re: K102012

Trade/Device Name: CXDI-70C Wireless Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: July 15, 2010 Received: July 16, 2010

AUG 2 3 2013

Dear Mr. Kubo:

This letter corrects our substantially equivalent letter of August 17, 2010.

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

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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K102012

# Indications for Use

510(k) Number (if known): k102012

Device Name: Cannon CXDI-70C Wireless

Indications for Use:

Digital Radiography CXDI-70C Wireless provides digital image capture for conventional fil/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) 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 In Vitro Diagnostic Devices (OIVD)

Ait

(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) Number K162012

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