CANON, DIGITAL RADIOGRAPHY, MODEL CXDI-50G

K031447 · Canon, Inc. · MQB · May 21, 2003 · Radiology

Device Facts

• Record ID: K031447
• Device Name: CANON, DIGITAL RADIOGRAPHY, MODEL CXDI-50G
• Applicant: Canon, Inc.
• Product Code: MQB · Radiology
• Decision Date: May 21, 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-50G 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

The Canon CXDI-50G is a portable solid-state X-ray imager used to capture and convert conventional projection X-ray images into digital format. It functions as a component within a larger system, requiring a separate control PC running designated system software (V6.0) to manage image capture, processing, and DICOM network transmission. The device is positioned on a table or in a holder during operation. A removable, external fixed grid is utilized to reduce scatter radiation. The system provides digital images for preview and diagnostic review by clinicians. By replacing film/screen systems, it enables digital workflow integration, potentially improving diagnostic efficiency and image management in clinical settings.

Clinical Evidence

No clinical data provided; substantial equivalence is based on bench testing and design control activities.

Technological Characteristics

Solid-state X-ray imager; portable form factor; 35x43cm imaging area; uses external removable fixed grid for scatter reduction; DICOM compatible; requires external control PC; software-controlled (V6.0).

Indications for Use

Indicated for patients requiring 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-31 (K003689)
• Canon CXDI-40G (K023750)

Submission Summary (Full Text)

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# MAY 21 2003

Prepared:

March 26, 2003

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]

# Proposed Device:

Fax Number:

| Reason For 510(k): | New Model |
|----------------------|-------------------------------|
| Manufacturer: | Canon Inc. |
| Trade Name: | Canon |
| Model Name: | CXDI-50G<br>✓ 6. 0 |
| Classification Name: | MQB, Solid State X-ray Imager |
| FDA 510(k) #: | To be assigned |

[phone]

#### Predicate Device:

| Manufacturer: | C |
|----------------------|---|
| Trade Name: | C |
| Model Name: | C |
| Classification Name: | 9 |
| FDA 510(k) #: | F |

anon Inc. 'anon XDI-31/CXDI-40G 0MQB, Solid State X-ray Imager 003689/K023750

### Description Of Device:

The Canon digital radiography CXDI-50G 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-50G is different from CXDI-31 and CXDI-40G in the following respect:

- · The CXDI-50G is a portable unit as same as the CXDI-31. It is positioned on a table or installed in a holder during its operation as a film cassette is while the CXDI-40G operates in conjunction with an upright stand, table, and universal stand.
The principle of the CXDI-50G is the same as the CXDI-40G, with some modifications of its housing in size and shape. The sensor of the CXDI-50G has the same characteristics as the CXDI-40G and the imaging area is changed from 43x43cm to 35x43cm.

The CXDI-50G 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-50G achieves performance stated herein (such as image capturing, DICOM

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Intended Use:

Canon digital radiography CXDI-50G 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.

## Descriptive Comparison

The predicate devices are the Canon digital radiography CXDI-40G cleared under Document Number K023750 on November 22, 2002 and CXD1-31 cleared under Document Number K003689 on January 2, 2002.

The CXDI-50G's technical specifications, imaging principle, physical characteristics and intended use are the same as those of the CXDI-40G including pixel pitch. However, the differences in the design are as follows:

- · The mechanical structure and physical appearance of the CXDI-50G are different than the CXDI-31 and the CXDI-40G. Additional information can also be found in the CXDI-50G User's Manual provided in this submission.
- · A removable, fixed grid is used for the CXDI-50G the same as the CXDI-31 and the CXDI-40G. The both grids for the CXDI-50G and the CXDI-31 are installed outside the sensor housing, while the gird for the CXDI-40G is instated inside the sensor housing. Both types of grids are used for eliminating the scatter X ray in exposures that use films.

Regarding the software:

- The system software for controlling CXDI-50G is released as V6.0. •
- . V6.0 includes some changes from V5.0.
- · The main changes of the V6.0 are the addition of the control of CXDI-50G sensor and some change of GUI.
- · V5.0 was first introduced and cleared under K023750 and is currently used in Canon models the CXDI-40G.

Based on the information in this submission, similarity to the predicate devices (the Canon digital radiography CXDI-31 and the CXDI-40G), and the results of our design control activities, it is our opinion that the Canon digital radiography CXDI-50G described in this submission is substantially equivalent to the predicate devices.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 21 2003

Canon, Inc. % Mr. Joseph Murnane Senior Staff Engineer Underwriters Laboratories, Inc. Melville Division 1285 Walt Whitman Road MELVILLE NY 11747-3081

Re: K031447

Trade/Device Name: Canon, Digital Radiography Model CXDI-50G Regulation Number: 21 CFR 892.1630 Regulation Name: Electrostatic x-ray imaging system Regulatory Class: II Product Code: 90 MOB Dated: May 7, 2003 Received: May 7, 2003

Dear Mr. Murnane:

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:

| 8xx.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

| 510(K)Number(if known): | K 031447 |
|-------------------------|----------------------------------------|
| Device Name: | CANON DIGITAL RADIOGRAPHY CXDI-50G-V6. |

| Page | 1 of 1 |
|------|--------|
|------|--------|

Indications for Use:

CANON DIGITAL RADIOGRAPHY CXDI-50G 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.

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

Concurrence of CDRH, Office of Device Evaluation(ODE)

| Prescription Use<br>(Per 21 CFR 801.109) | <div> <span style="text-decoration: overline;"> <span style="position: relative; bottom: 5px;">✓</span> </span> </div> |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------|
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------|

OR

| Over-The-Counter Use | <span style="text-decoration: overline;"></span> |
|----------------------|--------------------------------------------------|
|----------------------|--------------------------------------------------|

(Optional Format 1-2-96)

Nancy C. Brogdon
(Division Sign-Off)

Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number k031447