CANON X-RAY DIGITAL CAMERA, MODEL CXDI-22

K992547 · Canon USA, Inc. · MQB · Oct 13, 1999 · Radiology

Device Facts

• Record ID: K992547
• Device Name: CANON X-RAY DIGITAL CAMERA, MODEL CXDI-22
• Applicant: Canon USA, Inc.
• Product Code: MQB · Radiology
• Decision Date: Oct 13, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1680
• Device Class: Class 2

Intended Use

CANON X-RAY DIGITAL CAMERA CXDI-22 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

CXDI-22 is a digital X-ray retrofit kit for installation into existing radiologic tables; captures and converts conventional projection X-ray images to digital format. Input: X-radiation from external generator; Output: digital images for preview, diagnostic viewing, and DICOM network transmission. Operated by radiology staff in clinical settings. Device uses amorphous silicon TFT array with fluorescent screen (Gd2O2S:Tb3+) to detect X-rays. Digital processing optimizes gray-scale. Enables transition from film/screen to digital radiography; facilitates efficient image storage and transmission.

Clinical Evidence

Bench testing only. No clinical data provided. Performance equivalence established through comparison of technical specifications, including MTF (42% at 2lp/mm) and dynamic range (14-bit A/D, 12-bit output), against the predicate device.

Technological Characteristics

X-ray absorber: Gd2O2S:Tb3+ fluorescent screen (545nm emission). Sensing: Amorphous Silicon TFT array (540-620nm detection). Energy: External X-ray generator. Connectivity: DICOM compatible digital network. Compliance: IEC 601-1-2. Processing: Digital gray-scale optimization.

Indications for Use

Indicated for general purpose diagnostic radiographic procedures in the general population 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-11 (K981556)

Submission Summary (Full Text)

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OCT 1 3 1999

K99 2547

# 510(k) Summary

CANON U.S.A., INC. ONE CANON PLAZA LAKE SUCCESS, NY 11042-1198 TELEPHONE [phone] GENERAL FAX TELEPHONE [phone]

# Prepared:

an

July 19, 1999

### Submitter:

Canon USA, Inc. (U.S. designated agent for Canon Inc.) Company Name: Company Address: One Canon Plaza Lake Success, NY 11042 Ken Shadoff, Senior Product Safety Engineer Contact Person: [phone] Phone Number: [phone]

## Proposed Device:

Fax Number:

| Reason For 510(k): | New Model |
|----------------------|-------------------------------|
| Manufacturer: | Canon Inc. |
| Trade Name: | Canon |
| Model Name: | CXDI-22 |
| Classification Name: | MQB, Solid State X-ray Imager |
| FDA 510(k) #: | To be assigned |

#### Predicate Device:

| Manufacturer: | Canon Inc. |
|----------------------|--------------------------------|
| Trade Name: | Canon |
| Model Name: | CXDI-11 |
| Classification Name: | 90MQB, Solid State X-ray Image |
| FDA 510(k) #: | K981556 |

#### Description Of Device:

The Canon X-ray digital camera model CXDI-22 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.

Canon X-ray digital camera CXDI-22 is different from CXDI-11 in the following respect:

- · Model CXDI-11 operates in conjunction with an upright stand, while model CXDI-
- 22 is a retrofit kit for installation into an existing radiologic table.

#### Intended Use:

Canon X-ray digital camera CXDI-22 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.

#### Technical Characteristics:

Please refer to the attached COMPARISON CHART.

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# Table of comparison

| Item | | CXDI-11 | CXDI-22 |
|--------------------------|----------------|-------------------------------------------------------------------------------------------|---------------------------------------------------------------------|
| Intended Use | | Provide diagnostic images for general radiography with upright system | Provide diagnostic images for general radiography with table system |
| Desgin | | Digital acquisistion, electronic processing | Same |
| Energy Uses | | Receives x-radiation generated by external x-ray generator | Same |
| Materials | X-ray Absorber | Fluorescent screen( $Gd_2O_2S:TB^{3+}$ )<br>Visible emission peak: 545nm | Same |
| | Sensing Means | Amorphous Silicon W/TFT Array Detection peak:540-620nm | Same |
| Anatomical Sites | | General radiography | Same |
| Target Population | | General population | Same |
| Physical Safety | | Minimize exposure to x-radiation | Same |
| Compliance with Standard | | Complies with IEC 601-1-2 | Same |
| Biocompatibility | | N/A | N/A |
| Performance | | After digital processing(optimize the gray-scale) | Same |
| Labeling | | Approved 510(K) | See attachment labeling |
| MTF | | MTF@2lp/mm 42% | Same |
| Dynamic Range | | Dyanamic range:<br>approximately 4 digit<br>(linear A/D : 14bit)<br>(output data : 12bit) | Same |
| Sensor Unit | | 552 x 598 x 231mm | 604 x 645 x 73.5or69mm |
| Power Supply | | 580 x 489 x 275mm | 390 x 160 x 110mm |
| Control PC | | 483.5 x 594 x 300mm | 453 x 594 x 300mm |
| Operation Unit | | 298 x 209.5 x 130mm | Same |
| Card Reader | | 50 x 180 x 39mm | Same |
| Stand | | 900 x 475 x 2100mm | N/A |
| Table | | N/A | N/A |

:

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo includes the department's emblem on the left, followed by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in bold, sans-serif font. The emblem features a stylized representation of a human figure within a circular border.

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

Mr. Ken Shadoff Senior Product Safety Engineer Canon USA. Inc. One Canon Plaza LAKE SUCCESS NY 11042-1198

AUG 23 2013

Re: K992547

Trade/Device Name: Model CXDI-22 X-ray Digital Camera Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: July 29, 1999 Received: July 30, 1999

Dear Mr. Shadoff:

This letter corrects our substantially equivalent letter of October 13, 1999.

We have reviewed your Section 510(k) premarket notification of intent to market the indication we nave reviewed your Section 510(x) promants is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed interstate for use stated in the encrosule) to regary manated to the Medical Device Amendments, or to commerce prior to May 20, 1970, the character with the provisions of the Federal Food, Drug, devices that nave been recials in accorded in accorded approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a presisions of the Act. The and Cosmelle Act (Act) that do not require apple on the general controls provisions of the Act. The You may, defector, market the device, sayler to increasents for annual registration, listing of
general controls provisions of the Act include requirements for annual registr general controls provisions of the fict mention and prohibitions against misbranding and adulteration.

If your device is classified (see above) into class II (Special Controls), it may be subject to such If your device is classified (see above) into enose (ope your device can be found in Title 21, additional controls. Existing major regulations and to 895. In addition, FDA may publish further Code of Poucharts concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Prease be advised that FDA s issualled of a succession with other requirements of the Act
that FDA has made a determination that your device complies . You must that FDA lias made a decemmation that your seered by other Federal agencies. You must a or any Peteral statules and regulations adminities, but not limited to: registing (21)
comply with all the Act's requirements, including, but not limited to secting of comply with all the Act 3 requirements, incrueing, Strates call device reporting (reporting of

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# Page 2

medical device-related adverse events) (21 CFR 803); and good manufacturing practice medical device-related aurelse ovense (OS) regulation (21 CFR Part 820). This letter requirements as set forur in the quality of the as described in your Section 510(k) prematet will allow you to begin marketing your active af your device to a legally marketed nothication. The FDA midnig of backan 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 CFF) Parts 801 and If you desire specific advice for your device of the Evaluation and Safety at (301) 796809), please contact the Office of In Vitro Diagnostic Device Eyaluation and arcrease 5450. Also, please note the regulation entitled, "Misbranding by reference to premarket 1450. Also, please note the regulations regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to under the MDK regulation (21 CFR Pat 005), promo go go 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. 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 Statement

K992547 510(K)Number(if known):

CKDI-22 Device Name:

Indications for Use:

CANON X-RAY DIGITAL CAMERA CXDI-22 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.

# NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHERT NEEDE

Concurrence of CDRH, Office of Device Evaluation(ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

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of

David A. Syverson

OR

(Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological Dev 510(k) Number

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