CANON X-RAY DIGITAL CAMERA WITH ADDITIONAL SOFTWARE, LANMIX MLT

K023124 · Canon, Inc. · MQB · Oct 4, 2002 · Radiology

Device Facts

• Record ID: K023124
• Device Name: CANON X-RAY DIGITAL CAMERA WITH ADDITIONAL SOFTWARE, LANMIX MLT
• Applicant: Canon, Inc.
• Product Code: MQB · Radiology
• Decision Date: Oct 4, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1680
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

Canon Xray digital camera CXDI-11/ CXDI-11 LANMIX MLT add. version provide 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-11 LANMIX MLT is a solid-state X-ray imager that captures and converts conventional projection X-ray signals into digital images. The device incorporates 'Multi-objective Frequency Processing' (MLT) software to enhance image quality. Captured images are sub-sampled for display on a preview monitor; diagnostic-quality images are transmitted via a DICOM-compatible network for printing or storage. Used in clinical settings for general-purpose radiographic procedures, the system is operated by trained radiology staff. The digital output replaces traditional film/screen workflows, allowing for faster image review and integration into digital hospital networks, potentially improving diagnostic efficiency and workflow for healthcare providers.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and bench testing of the added software processing feature.

Technological Characteristics

Solid-state X-ray imager; digital image capture; DICOM-compatible network connectivity; software-based Multi-objective Frequency Processing (MLT).

Indications for Use

Indicated for general purpose diagnostic radiographic examinations, replacing conventional film/screen systems for patients requiring X-ray imaging.

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 0 4 2002

### 510(k) Summary

Prepared:

#### August 1, 2002

KO23/24

#### Submitter:

Company Name: Company Address:

Contact Person: Phone Number: Fax number:

Canon U.S.A., Inc. (U.S. designated agent for Canon Inc.) Onc Canon Plaza Lake Success, NY 11042 Sheila Driscoll, Senior Product Safety Engineer [phone] [phone]

Proposed Device:

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

New Model Canon Inc .-Canon CXDI-11 LANMIX MLT add. version 90MQB, Solid State X-ray Imager To be assigned

Predicate Device:

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

Canon Inc. Canon CXDI-11 90MQB, Solid State X-ray Imager K981556

#### Description Of Device:

The Canon X-ray digital camera model CXDI-11 LANMIX MLT add. version 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 X-ray Digital Camera CXDI-11 LANMIX MLT add. version is substantially equivalent to the Canon Xrray Digital Camera CXDI-11. It differs from the CXDI-11 in that the LAN MIX MLT software was added to make possible the Multi-objective Frequency Processing.

#### Intended Use:

Canon Xray digital camera CXDI-11/ CXDI-11 LANMIX MLT add. version provide 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.

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Image /page/1/Picture/0 description: The image shows the logo of the Department of Health & Human Services. The logo consists of a symbol on the left and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" on the right. The symbol is a stylized representation of a human figure, and the text is in a bold, sans-serif font.

Public Health Service

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

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

AUG 2 3 2013

Re: K023124

Trade/Device Name: LANMIX MLT add. Version of Canon X-ray Digital Cameras Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MOB Dated: September 13, 2002 Received: September 19, 2002

Dear Mr. Murnane:

This letter corrects our substantially equivalent letter of October 4, 2002.

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. 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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# Attachment 2

### Indications for Use Statement

510(k) Number (if known)

K023124

Device Name

LANMIX MLT add. version of Canon X-ray Digital Cameras

Indications for Use

LANMIX MLT add. version of Canon's X-ray Digital Cameras 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 ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR Over-The-Counter Use

David A. Lawson

(Division Sign-Off) Division of Reproductive. Ab and Radiological Device 510(k) Number