I-DIXEL

K073704 · J. Morita USA, Inc. · LLZ · Feb 21, 2008 · Radiology

Device Facts

• Record ID: K073704
• Device Name: I-DIXEL
• Applicant: J. Morita USA, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Feb 21, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

i-Dixel is a software for management of images obtained from x-ray imaging equipment and other imaging modalities. i-Dixel is used for medical and dental image examination and diagnosis. The software is to be operated and used by doctor, dentists and other legally qualified professionals.

Device Story

i-Dixel is a medical/dental diagnostic application for processing, archiving, and managing patient images and records; operates in network environments. Inputs include 2D/3D X-ray images from J. Morita modalities, TWAIN-compliant devices, and video camera imports. System features include database management, image viewing, printing, and import/export functions. Operated by doctors, dentists, and qualified professionals in medical/dental settings. Includes password-protected operator authentication to prevent data loss or operational errors. Output consists of displayed or printed diagnostic images used by clinicians to support diagnostic decision-making.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Software-based PACS/image viewer. Operates on networked systems. Supports TWAIN-compliant modalities and J. Morita proprietary imaging hardware. Includes database management, password-based user authentication, and image import/export capabilities. No specific hardware materials or sterilization required as it is a software-only device.

Indications for Use

Indicated for medical and dental professionals to manage, examine, and diagnose images obtained from X-ray and other imaging modalities.

Regulatory Classification

Identification

A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.

Special Controls

*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).

Predicate Devices

• 3D Accu-I-tomo XYZ Slice View Tomograph (K030450)

Reference Devices

• N-Liten (incorporated to ProMax 3D)

Submission Summary (Full Text)

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# 073704

### 510(k) SUMMARY J. Morita USA Inc.'s i-Dixel

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# 1. Submitter Name and Address with Phone/Fax

Registration No. 2081055 Registration No. 3002807636 Initial Distributor: Manufacturer: J. Morita USA, Inc. J. MORITA MFG. CORP. 9 Mason 680 Higashihama Minami-cho Irvine, CA 92618 Fushimi-ku, Kyoto USA Japan 612-8533 Telephone: [phone] [phone] Facsimile: 949-581-9688 [phone]

#### 2. Contact Person

Keith A. Barritt Fish & Richardson P.C. 1425 K Street, N.W. Suite 1100 Washington, DC 20005 Phone: [phone] Facsimile: [phone]

#### 3. Date Summary Prepared

November 12, 2007

#### 4. Device Name

Trade or Proprietary Name:

i-Dixel

Common Name:

Product Code:

Image viewer software

Classification Name:

Picture archiving and communications system (21CFR892.2050) LLZ

#### 5. Substantial Equivalency

Substantial equivalency is claimed against the following devices:

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i-Dixel is practically the same as 3DX Integrated Information System, which is incorporated in our legally marketed device, 3D Accu-I-tomo X YZ Slice View Tomograph (K030450). i-Dixel is also presumably the same as N-Liten which is incorporated to ProMax 3D (Planmeca Ov, Finland).

#### 6. Description of the Device

i-Dixel is a medical and dental diagnostic application for processing, archiving, and managing diagnostic images from multiple imaging modalities and other patient information. i-Dixel processes acquired 2D/3D images for diagnostic use. Any patient record, name, ID, diagnosis, or image can be retrieved by simply clicking the mouse on the desired item in the easy-to-manage filing system made up of patient folders and their images.

i-Dixel is used in the medical environment and has the following functions as the entire system.

- 1) An image is acquired from X-ray equipment and saved in the database.
- 2) It saves data in the patient database besides the image.
- 3) Information in the image etc. saved in the patient data base can be seen,
- 4) It prints the image with applying information.
- 5) It makes maintenance of the patient database.
- 6) The image is imported and exported by various forms.
- 7) It is operated under the network environment.
- 8) It has the function of the input authentication by the password with operator ID to prevent patient's fault and data being lost by the operational mistake.
- 9) It is operated with 3D imaging modalities manufactured by J. Morita Mfg. Co.
- 10) It is operated with 2D imaging modalities or other panoramic/cephalometric x-ray device manufactured by J. Morita.
- 11) It can be connected with modalities which comply with TWAIN specifications.
- 12) It can incorporate images of device which is compatible to drivers including DixelD or 3DXD by J. Morita Mfg. Co.
- 13) It can import data from video camera.

#### 7. Intended Use

i-Dixel can be used as viewer or database of medical imaging to support the diagnostic by medical imaging.

#### 8. Safety and Effectiveness of the Device

i-Dixel is slightly revised version of 3DX Integrated Information System which is incorporated to FDA- cleared device (See below) in J. MORITA MFG. CORP.

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# Information of the device which 3DX Integrated Information System is incorporated:

ਾ

| No. | Device | 510(k) number | Functions of the device | NOTE |
|-----|-----------------|---------------|-------------------------------------|------|
| 1 | 3D accu-i- tomo | K030450 | Dental x-ray computed<br>tomography | 3D |

The i-Dixel is a slightly modified model from 3DX Integrated Information System but all changes are minor and don't pose any additional safety concerns. Safety charges are min has not changed between these two models and we judge these two software ane substantially equal.

Consequently, it is self-explanatorily evident that this i-Dixel is substantially equivalent to 3DX Integrated Information System which is incorporated to 3D Accu-I-tomo XYZ Slice View Tomograph (K030450) in the sense of similar characteristics.

3/3

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is a stylized symbol that resembles an eagle or bird with three curved lines representing its wings or feathers. The symbol is black and the text is also in black.

FEB 21 2008 Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

J. Morita USA, Inc. % Mr. Keith A. Barritt Attorney Fish & Richardson P.C. 1425 K Street, N.W., Suite 1100 WASHINGTON DC 20005

Re: K073704

Trade/Device Name: i-Dixel Image Viewer Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: December 28, 2007 Received: December 31, 2007

Dear Mr. Barritt:

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 (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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Image /page/3/Picture/10 description: The image is a circular logo commemorating the centennial of the FDA from 1906-2006. The letters FDA are in bold, stacked on top of the word "Centennial". The logo is surrounded by a circular border with text, but the text is not legible.

Protecting and Promoting Public Health.

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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.

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrb/industry/support/index.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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# Indications for Use

K673704

510(K) Number: anknown Device Name: i-Dixel Indications for Use:

i-Dixel is a software for management of images obtained from x-ray imaging equipment and other imaging modalities. i-Dixel is used for medical and dental image examination and diagnosis.

The software is to be operated and used by doctor, dentists and other legally qualified professionals.

Prescription Use AND/OR (Part21CFR801 Subpart D)

Over-The-Counter Use (Part21CFR807 Subpart C).

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation(ODB)

(Division Sign-Off).

Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(K) Number: L078704

Prescription Use (Part21CFR801.109) Over-The-Counter Use (Optional Format 1-2-96)

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

510(k) Number