DIGITAL RADIOGRAPHY

K111682 · Canon Inc. -Medical Equipment Group · MQB · Sep 2, 2011 · Radiology

Device Facts

• Record ID: K111682
• 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 CXD1-501G and CXD1-501C 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 (35.0 x 42.6 cm area) intercept X-ray photons; scintillator emits visible light; photo-detector array converts light to electrical signals; signals converted to digital values for monitor display. CXDI-501G uses Gadolinium Oxy-Sulfide (GOS) screen; CXDI-501C uses Cesium Iodide (CsI) screen for higher absorption. Devices housed for integration into standard X-ray stands and tables. Used by clinicians in diagnostic imaging environments to replace traditional film/screen systems. Output provides digital radiographic images for clinical review and diagnostic decision-making.

Clinical Evidence

Bench testing only. No clinical data provided. Performance demonstrated through electrical safety, electromagnetic compatibility, and non-clinical performance testing.

Technological Characteristics

Solid state X-ray imager; 35.0 x 42.6 cm imaging area. Scintillator materials: GOS (CXDI-501G) or CsI (CXDI-501C). Photo-detector array. Housing designed for stand/table integration. Digital output.

Indications for Use

Indicated for digital image capture in conventional film/screen radiographic examinations for general purpose diagnostic procedures. 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 COMPACT/CXDI-401C COMPACT (K103591)
• Digital Radiography CXDI-55C (K091436)
• Digital Radiography CXDI-55G (K091435)

Submission Summary (Full Text)

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K111682
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Section 5: 510(k) Summary

# 510(k) Summary

SEP - 2 2011

#### Prepared:

-

June 14, 2011

### 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) #:

New Model Canon Digital Radiography CXDI-501G Digital Radiography CXDI-501C 90MQB, Solid State X-ray Imager To be assigned

#### Predicate Device:

Trade Name: Canon

FDA 510(k) #/Model Name:

K 103591/ Digital Radiography CXDI-401G COMPACT/CXDI-401C COMPACT K091436/ Digital Radiography CXDI-55C K091435/ Digital Radiography CXDI-55G Classification Name: 90MOB, Solid State X-ray Imager

#### Description of Device:

The Digital Radiography CXDI-501G and CXDL-501C are solid state x-ray imagers which have 35.0 x 42.6 cm imaging area. The device intercepts x-ray photons and the scintillator 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 CXDI-501G uses GOS (Gadolium Oxy-Sulfide) as the material for fluorescent screen, while CXDI-501C uses Csl (Cesium Iodide) which provides high x-ray absorption as fluorescent screen. Both models employ housing for easy installation in stand and table unit.

#### Intended Use:

The Digital Radiography CXD1-501G and CXD1-501C 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 imaging principle and intended use of the Digital Radiography CXDI-501G and CXDI-501C are the same as those of the predicate devices (Digital Radiography CXDI-401G COMPACT, CXDI-401C COMPACT, CXDI-55C or CXDI-55G).

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K 111\1682
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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-501G and CXDI-501C are as safe and effective as the predicate devices (Digital Radiography CXD1-401G COMPACT, CXDI-401C COMPACT, CXDI-55C or CXDI-55G). 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 our opinion that the Digital Radiography CXDI-501G and CXDI-501C described in this submission are substantially equivalent to the oredicate devices.

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Image /page/2/Picture/0 description: The image shows the logo of the Department of Health & Human Services. The logo consists of a symbol with three figures and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" to the right of the symbol. The symbol and text are in blue.

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: K111682

Trade/Device Name: Canon/Digital Radiology, CXDI-501G/CXDI-501C Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MOB Dated: June 27, 2011 Received: June 28, 2011

Dear Mr. Asaka:

This letter corrects our substantially equivalent letter of September 2, 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 requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter requirents as set form in the quality of the seescribed in your Section 510(k) premarket will anow you to begin marketing your avrile as valence of your device to a legally marketed noutication. The IDA imanig of succion 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 advice for your device of the engles Eyaluation and Safety at (301) 796-607), prease vonaot 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 MDK regulation (27 CFFF at 065), processor of 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 Tour may 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 for Use

510(K) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: CXDI-501G and CXDI-501C

Indications for Use:

DIGITAL RADIOGRAPHY CXDI-501G and CXDI-501C 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 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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