CANON X-RAY DIGITAL CAMERA CXDI-11

K981556 · Canon USA, Inc. · MQB · Nov 4, 1998 · Radiology

Device Facts

• Record ID: K981556
• Device Name: CANON X-RAY DIGITAL CAMERA CXDI-11
• Applicant: Canon USA, Inc.
• Product Code: MQB · Radiology
• Decision Date: Nov 4, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1680
• Device Class: Class 2

Intended Use

CANON X-RAY DIGITAL CAMERA CXDI-11 is indicated for use in generating radiographic Images of human anatomy. It is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures.

Device Story

Device captures projection X-ray images using amorphous silicon TFT array sensor; replaces conventional film/screen systems. X-rays strike fluorescent screen; light detected by sensor; converted to digital data. System performs digital image processing to optimize gray-scale visualization post-exposure. Output includes digital images for preview monitor, network transmission, and hardcopy printing. Used in clinical settings for general radiography; operated by radiology staff. Digital capture allows wider dynamic range and post-processing compared to analog film; benefits include improved image visualization and elimination of wet chemical processing.

Clinical Evidence

Clinical study compared digital images from CXDI-11 to conventional analog film. Qualified readers evaluated inpatient cases for overall and anatomical-specific image quality. Results consistently showed digital film quality was equivalent or superior to analog film. Reader consistency was assessed via repeat readings; variance between readings was comparable to variance between digital and analog modalities.

Technological Characteristics

Amorphous Silicon TFT array sensor; fluorescent screen (Gd2O2S:Tb3+). 14-bit linear A/D conversion; 12-bit output data. Complies with IEC 601-1-2. Digital image processing for gray-scale optimization. MTF@2lp/mm 42%.

Indications for Use

Indicated for general purpose diagnostic radiographic examinations of human anatomy in the general population. Intended 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

• Radiographic Film (892.1840)
• Radiographic Intensifying Screen (892.1960)

Submission Summary (Full Text)

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#### 4 1998 NOV

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## 510(k)Summary

| 1.Date Prepared: | April 1, 1998 | | |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|--|
| 2.Applicant's Name: | Canon USA, Inc. | | |
| | One Canon Plaza. | | |
| | Lake Success, NY 11042 | | |
| | Mr. Glenn Impal/Mr. Ken Shadoff | | |
| | Phone: | [phone] | |
| | Fax. | [phone] | |
| 3.Model Name: | CANON X-RAY DIGITAL CAMERA CXDI-11 | | |
| | 90MQB, Solid State X-ray Imaging Device | | |
| 4.Predicate Model: | Radiographic Film (892.1840) | | |
| | Radiographic Intensifying Screen (892.1960) | | |
| 5.Device Description: | CANON X-RAY DIGITAL CAMERA CXDI-11 is used to directly capture and<br>convert conventional projection X-ray images to digital images. A sub-sampled<br>image can be displayed on a preview monitor for viewing.<br>The diagnostic image can be transmitted through a digital network for printing.<br>The device provides digital image capture for conventional film/screen<br>radiographic examinations.<br>CANON X-RAY DIGITAL CAMERA CXDI-11 differs from traditional X-ray<br>systems in that instead of exposing a film for subsequent wet chemical<br>processing to create a hardcopy image, a device is used to capture the image in<br>electronic form. The digital data are then used to produce diagnostic hardcopy<br>and reference-softcopy images. | | |
| 6.Intended Use: | CANON X-RAY DIGITAL CAMERA CXDI-11 is indicated for use in generating<br>radiographic Images of human anatomy. It is intended to replace radiographic<br>film/screen systems in all general purpose diagnostic procedures. | | |
| 7.Comparison to<br>predicate Device | CANON X-RAY DIGITAL CAMERA CXDI-11 device uses an electronic readout<br>of an image while conventional film/screen systems require chemical processing<br>to produce image.<br>CANON X-RAY DIGITAL CAMERA CXDI-11 device produces a digital image<br>while conventional film/screen systems produce an analog image. | | |

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# 510(K) Summary (continued)

### Clinical Evaluation of Canon Digital Radiography System, Model CXDI-11

A study was conducted to evaluate whether image quality of film obtained from the Canon Digital Radiography System is substantially equivalent to conventional x-ray film. Qualified readers evaluated both digital and analog films from various inpatient cases. Films were evaluated for overall image quality, as well as for image quality with respect to specific anatomical areas. The difference between image quality scores for digital and analog film consistently indicated that the quality of the two types of film was equivalent or that digital film was of higher quality. Several different statistical techniques were used to confirm this finding.

To evaluate the consistency of the study readers, a number of analog films were read twice by each reader, separated by a period of time. Results showed that readers were able to read the films in a consistent fashion, but that the magnitude of difference between their two readings was comparable to the difference between the two types of film.

It can be reasonably concluded that the image quality of films obtained with Canon's Digital Radiography System is substantially equivalent to that obtained with conventional analog film.

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| Item | CXDI-11 | Screen-Film system | Comment | |
|-------------------|------------------------------------------------------------|----------------------------------------------------------------------|-----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Provide diagnostic images for general radiography use | Same | N/A | |
| Design | Digital acquisition, electronic processing | Analog acquisition, chemical processing | N/A | |
| Energy Uses | Receives x-radiation generated by external x-ray generator | Same | CXDI-11 operates from AC power sou | |
| Materials | X-ray Absorber | Fluorescent screen<br>(Gd₂O₂S:Tb³⁺)<br>Visible emission peak : 545nm | Same | In Screen-Film system, a film sandwiched in between fluorescent screens, although a fluorescent screen is placed in front of the sensor panel in CXDI-11 |
| | Sensing Means | Amorphous Silicon W/ TFT Array<br>Detection peak: 540nm ~ 620nm | Silver halide film<br>Detection peak: 430nm ~ 680nm | Screen-Film system image is blurred with diffusion of two fluorescent screens which are placed both sides of film. |
| Anatomical Sites | General radiography | Same | N/A | |
| Target Population | General population | Same | N/A | |

# Table of comparison

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| Physical Safety | Minimize exposure to<br>x-radiation | Same | N/A |
|------------------------------|--------------------------------------------------------------------------------------------|-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Compliance with<br>standards | Complies with IEC 601-1-2 | N/A | N/A |
| Biocompatibility | N/A | N/A | N/A |
| Performance | After digital processing<br>(optimize the gray-scale) | Development of film<br>(use the own gray-scale) | CXDI-11 performs the digital image processing, and can optimize its image visualization even after exposure. Films Screen-Film system has their own H character, and its gray-scale is fixed exposure condition. |
| Labeling | See attached labeling | N/A | N/A |
| MTF | MTF@2lp/mm 42% | MTF@2lp/mm 33%<br>(Lanex 250/TMS-RA)<br>(Kodak) | The CXDI-11 sensor plate itself does not have blur theoretically. |
| Dynamic Range | Dynamic range:<br>approximately 4 digit<br>(linear A/D : 14 bit)<br>(output data : 12 bit) | Dynamic range:<br>approximately 1.5 digit | CXDI-11 can utilize wider dynamic range to control the image visualization. |

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DEPARTMENT OF HEALTH & HUMAN SERVICES USA

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 4 1998

Ken Shadoff Senior Product Safety Engineer Quality Management Dept. Cannon U.S.A., Inc. One Cannon Plaza Lake Success, NY 11042-1198 Re:

K981556 Canon X-Ray Digital Camera CXDI-11 Dated: August 19, 1998 Received: September 14, 1998 Regulatory class: Unclassified Procode: 90 MOB

Dear Mr. Shadoff:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address "http://www.fda.gov/cdrividsma/dsmamain.html".

Sincerely yours,

Lillian Yih

Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications Statement

× 98 127 6 510(K)Number(if known):

Page of

Device Name: and CxnI - Il

Indications for Use:

CANON X-RAY DIGITAL CAMERA CXDI-11 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.

DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHERT GE IF NEEDED)

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)

Elinil A. Symm

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number K981556