DIGITAL RADIOGRAPHY CXDI-50C

K060433 · Canon, Inc. · MQB · Mar 10, 2006 · Radiology

Device Facts

• Record ID: K060433
• Device Name: DIGITAL RADIOGRAPHY CXDI-50C
• Applicant: Canon, Inc.
• Product Code: MQB · Radiology
• Decision Date: Mar 10, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1680
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

DIGITAL RADIOGRAPHY CXDI-50C 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

Portable solid-state X-ray imager; captures and converts conventional projection X-rays into digital images. Uses amorphous silicon array with Cesium Iodide (CsI) fluorescent screen for high X-ray absorption. Operated in clinical settings; positioned on tables or in holders. Requires external control PC with designated system software for image capture and DICOM network transmission. Provides preview images; enables diagnostic image transfer for printing. Benefits include reduced X-ray dosage and improved Detective Quantum Efficiency (DQE) compared to GOS-based predecessors.

Clinical Evidence

Bench testing only. No clinical data provided. Performance improvements (DQE, X-ray dosage) are based on technical specifications of the CsI fluorescent screen compared to the GOS screen used in predicate devices.

Technological Characteristics

Amorphous silicon array sensor; Cesium Iodide (CsI) fluorescent screen; 35x43cm imaging area. Portable form factor. Connectivity via DICOM-compatible digital network. Requires external control PC. No internal control hardware.

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)
• Canon CXDI-40C (K031633)

Submission Summary (Full Text)

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K060433

# 510(k) Summary

Prepared:

December 9, 2005

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

New Model Canon Inc. Canon CXDI-50C MQB, Solid State X ray Imager To be assigned

Predicate Device:

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

Canon Inc. Canon CXDI-50G 90MQB, Solid State X ray Imager K031447

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

Canon Inc. Canon CXDI-40C 90MQB, Solid State X-ray Imager KO31633

Description Of Device: The Canon digital radiography CXI)1-50C is used to directly capture and convert conventional projection X ray images to digital images. A sub-sampled image can be displayed on a preview monitor for viewing. The diagnostic image can be transmitted through a DICOM compatible digital network for printing. The device provides digital image capture for conventional film/screen radiographic examinations.

> The Canon digital radiography CXDI-50C is different from CXDI-50G and CXDI-40C in the following respect:

- * The CXDI-50C is a portable unit as same as the CXDI-50G. It is positioned on a table or installed in a holder for a stand or a table during its operation as is the case with a film cassette, while the CXDI-40C operates in conjunction with an upright stand, table, and universal stand.
- · Both the CXDI-50C and the CXDI-50G use the same amorphous silicon alley as the sensing mcans, however, the 10-1

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#### Section 10: Summary

CXDI-50C uses the different material for fluorescent screen which is deposited on the amorphous silicon array with from the CXD1-50G. The CXDI-50C uses Csl (Cesium Iodide) while CXD1-50G uses GOS (Gadolium Oxy-Sulfide). Because of CsI which provides high xray absorption as fluorescent screen, CXDI-50C delivers diagnostic images with the x ray dosage less than that required by CXDI-50G and CXDI-50C's DQE approximately doubles compared to CXDI-50G.

The principle of the CXI)I-50C is the same as the CXDI-40C, with some modifications of its housing in size and shape. The sensor of the CXDI:50C has the same characteristics as the CXDI:40C and the imaging area is changed from 43x43cm to 35x43cm.

The CXDI-50C itself is a component without a control PC. Using a general purpose computer with appropriate specifications and the designated system software installed in it, as a control PC, the CXDI-50C achieves performance stated herein(such as image capturing, DICOM transfer and etc.)

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol that resembles a person with outstretched arms.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Canon, Inc. % Mr. Morten S. Christensen Program Reviewer Underwriters Laboratories, Inc. 12 Laboratory Drive, P.O. Box 13995 Research Triangle Park, NC 27709-3995

Re: K060433

AUG 2 3 2013

Trade/Device Name: CXDI-50C Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MOB Dated: February 8, 2006 Received: February 21, 2006

Dear Mr. Christensen:

This letter corrects our substantially equivalent letter of March 10, 2006.

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 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. Morri 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): K060433

Device Name: CXDI-50C

Indications For Use:

DIGITAL RADIOGRAPHY CXDI-50C 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 (Part 21 CFR 801 Subpart D)

AND/OR

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

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

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

Ancyc broston

(Division Sign-Off) Division of Reproductive, Abdo and Radiological Devices 510(k) Number _

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