CANON INC., DIGITAL RADIOGRAPHY, MODEL CXDI-40C

K031633 · Canon USA, Inc. · MQB · Jun 11, 2003 · Radiology

Device Facts

• Record ID: K031633
• Device Name: CANON INC., DIGITAL RADIOGRAPHY, MODEL CXDI-40C
• Applicant: Canon USA, Inc.
• Product Code: MQB · Radiology
• Decision Date: Jun 11, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1680
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

Canon digital radiography CXDI-40C 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.

Device Story

Solid state X-ray imager; captures and converts conventional projection X-rays into digital images. Input: X-ray radiation; Output: digital images for preview and transmission via DICOM network. Operates in conjunction with upright stand, table, or universal stand; requires control PC. Used in clinical settings for general purpose diagnostic procedures. Employs Cesium Iodide (CsI) fluorescent screen on amorphous silicon array; provides higher X-ray absorption and higher DQE compared to GOS-based predecessors; enables diagnostic imaging at approximately half the X-ray dosage. Facilitates transition from film/screen to digital radiography; aids clinicians in diagnostic decision-making through digital image availability.

Clinical Evidence

Bench testing only. Evidence focuses on technical performance improvements (DQE and X-ray dosage reduction) resulting from the transition from GOS to CsI fluorescent screen technology.

Technological Characteristics

Solid state X-ray imager; amorphous silicon array; Cesium Iodide (CsI) fluorescent screen; DICOM compatible; requires external control PC; operates with upright/universal stands or tables.

Indications for Use

Indicated for patients undergoing general purpose diagnostic radiographic examinations to replace conventional film/screen systems.

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-40G (K023750)

Submission Summary (Full Text)

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# Section 10: Summary Koz 1633 510(k) Summary

#### Prepared:

April 8, 2003

| Submitter: | |
|------------|--|

Company Name: Company Address:

Contact Person: Phone Number: Fax Number:

Canon USA, Inc. (U.S. agent for Canon Inc.) One Canon Plaza Lake Success, NY 11042 Ms. Sheila Driscoll [phone] [phone]

#### Proposed Device:

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

New Model Canon Inc. Canon CXDI-40C צו יורק // CXDI-40C MQB, Solid State X-ray Imager 892.1630 To be assigned

#### Predicate Device:

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

Canon Inc. Canon CXDI-40G V 6, V MQB, Solid State X-ray Imager 892.1630 K023750

#### Description Of Device:

The Canon digital radiography CXDI-40C 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-40C is different from CXDI-40G in the following respect.

- Both the CXDI-40C and the CXDI-40G use the same amorphous silicon alley as the . sensing means, however, the CXDI-40C uses the different material for fluorescent screen which is deposited on the amorphous silicon array with from the CXDL-40G. The CXDI-40C uses CsI (Cesium Iodide) while CXDI-40G uses GOS (Gadolium Oxy-Sulfide). Because of CsI which provides high x-ray absorption as fluorescent screen, CXDI-40C delivers diagnostic images with approximately half the xray dosage required by CXDI-40G and CXDI-40C's DQE approximately doubles compared to CXDI-40G.
Since the same amorphous silicon array is used, the CXDI-40C's imaging size, number of pixels and pixel pitch are the same as those of CXDI-40C as well as CXDI-40G operates in conjunction with an upright stand, table, and universal stand. CXDI-40C's housing size and shape are almost as same as those of CXDI-40G.

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KO31633

### Section 10: Summary

Control PC is required to operate the CXDI-40C as well as the predicate devices.

Intended Use:

Canon digital radiography CXDI-40C 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.

Based on the information in this submission, similarity to the predicate devices (the Canon digital radiography the CXDI-40G), and the results of our design control activities, it is our opinion that the Canon digital radiography CXDI-40C described in this submission is substantially equivalent to the predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUN 1 1 2003

Canon, Inc. % Ms. Susan Gill Senior Project Engineer Underwriters Laboratories, Inc. 12 Laboratory Drive P.O. Box 13995 Research Triangle Park, NC 27709-3995

Re: K031633 Trade/Device Name: Digital Radiography Model CXDI-40C Regulation Number: 21 CFR 892.1630 Regulation Name: Solid state x-ray imaging system Regulatory Class: II Product Code: 90 MQB Dated: May 23, 2003 Received: May 27, 2003

Dear Ms. Gill:

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 either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

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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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

| 8xxx. 1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.

Sincerely yours.

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Section 3: Statement

## Indications Statement

Page | of

510(K)Number(if known): K031632

-40 C V 6.0 Device Name:

Indications for Use:

CANON DIGITAL RADIOGRAPHY CXDI-40C 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.

EASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHERT PAGE IF

OR

Concurrence of CDRH, Office of Device Evaluation(ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

David A. Seppam

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