RESOLUTIONMD, VERSION 1.3

K062164 · Calgary Scientific, Inc. · LLZ · Sep 22, 2006 · Radiology

Device Facts

• Record ID: K062164
• Device Name: RESOLUTIONMD, VERSION 1.3
• Applicant: Calgary Scientific, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Sep 22, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

ResolutionMD™ is a software based Picture Archiving and Communication System (PACS) used with general purpose computing hardware for the display and 3D visualization of medical image data. It provides for communication, storage, processing, rendering, and display of DICOM 3.0 compliant image data derived from various sources including CT and MRI. ResolutionMD™ is intended for use as a diagnostic, review, and analysis tool by trained professionals such as physicians, technologists, and nurses. When interpreted by a trained physician, reviewed images may be used as an element for diagnosis. It is the user's responsibility to ensure that the software is installed on appropriate hardware and that image quality is suitable for the clinical application. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.

Device Story

ResolutionMD™ is a software-based PACS for display and 3D visualization of DICOM 3.0 medical images (CT, MRI). It runs on general-purpose Windows or Macintosh hardware, utilizing dedicated graphics hardware for 3D rendering. Functions include 2D viewing, 3D volume rendering, Maximum Intensity Projection (MIP), and 2D/3D measurements. Operated by trained clinicians (physicians, technologists, nurses) in clinical settings, the software provides interactive tools for image manipulation. Physicians use the rendered outputs as an element for clinical diagnosis. The device benefits patients by enabling efficient review and analysis of diagnostic imaging data.

Clinical Evidence

Bench testing only. The software underwent extensive testing on multiple platforms by development/QC teams and beta testers. A hazard analysis was performed, and the software passed all critical safety tests with acceptable performance per predefined release criteria.

Technological Characteristics

Software-based PACS; runs on Windows or Macintosh OS; utilizes dedicated graphics hardware for 3D rendering. Supports DICOM 3.0/3.10 standards. Features include 2D viewer, 3D volume rendering, MIP with clipping planes, and measurement tools. No specific materials or energy sources; standalone software application.

Indications for Use

Indicated for use by trained professionals (physicians, technologists, nurses) for the display, review, and 3D visualization of DICOM 3.0 compliant medical images (CT, MRI) to assist in diagnosis. Contraindicated for primary interpretation of lossy compressed mammographic images or digitized film screen images; mammographic interpretation requires FDA-approved 5 Mpixel monitors.

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

• Lucion (K050033)
• Plug 'n View 3D (K992654)
• Vitrea 2 (K032748)

Submission Summary (Full Text)

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Kol 2164

#### 5 510(k) Summary

| Date Prepared: | July 21, 2006 |
|---------------------------------|---------------------------------------------------------------------------------------|
| Submitter's Name: | Calgary Scientific, Inc. |
| Submitter's Address: | 1210 20th Ave. SE, Calgary, Alberta, Canada T2G 1M8 |
| Submitter's Phone: | 403.270.7159 |
| Submitter's Fax: | 403.668.1689 |
| Contact: | Pierre Lemire, Chief Technology Officer |
| Proprietary Name: | ResolutionMD™ |
| Common Name: | Software PACS |
| Classification: | 892.2050 Picture archiving and communications system,<br>Product Code LLZ, (Class II) |
| Substantially<br>Equivalent to: | Tradename: Lucion<br>Manufacturer: Mevisys<br>510(k) Number: K050033 |
| | Tradename: Plug 'n View 3D<br>Manufacturer: Voxar Limited<br>510(k) Number: K992654 |
| | Tradename: Vitrea 2<br>Manufacturer: Vital Images, Inc.<br>510(k) Number: K032748 |

### Device Description:

ResolutionMD™ is a software based Picture Archiving and Communication System (PACS) used with general purpose computing hardware for the display and 3D visualization of medical image data. It provides for communication, storage, processing, rendering, and display of DICOM 3.0 compliant image data derived from various sources including CT and MRI. The ResolutionMD™ software takes advantage of dedicated graphics hardware to speed the creation 3D rendered images.

ResolutionMDTM is available in a Microsoft Windows version and in a Macintosh OS version. Both versions offer similar functionality. Available functions include DICOM communication, display of 2D images in original planes, computation and display of rendered 3D images and maximal intensity projection (MIP) images, and 2D and 3D image measurements. The user controls these functions with a system of interactive menus and tools.

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The ResolutionMD™ software has been extensively tested on a variety of platforms by both members of the development and quality control team and by potential customers serving as beta testers. A hazard analysis has been conducted and the level of concern has been classified as minor. The release version of the software passed all tests considered critical in terms of patient safety and demonstrated an overall acceptable performance for release as determined by the predefined release criteria.

| Feature | ResolutionMD™ | Mevisys<br>Lucion™ | Voxar Plug<br>'n View 3D™ | Vital<br>Vitrea 2™ |
|------------------------------------------|---------------------------------------------------------|--------------------|---------------------------|--------------------|
| Computer<br>Platform | Windows OS or<br>Mac OS | Windows OS | Windows OS | Windows OS |
| DICOM<br>compliance | DICOM 3.10 | DICOM 3.0 | DICOM 3.0 | DICOM 3.0 |
| 2D Imaging | 2D image viewer<br>with interactive<br>user controls | same | same | same |
| 3D Imaging | 3D volume<br>rendering with<br>interactive controls | same | same | same |
| Measurement | 2D measurement<br>tools | same | same | same |
| Maximum<br>Intensity<br>Projection (MIP) | MIP with<br>interactive controls<br>and clipping planes | same | same | same |
| Prescription Use | Yes | same | same | same |
| Intended Users | Trained<br>Professionals | same | same | same |

# Substantial Equivalence Comparisons to Predicate Devices:

## Intended Use:

ResolutionMD™ is a software based Picture Archiving and Communication System (PACS) used with general purpose computing hardware for the display and 3D visualization of medical image data. It provides for communication, storage, processing, rendering, and display of DICOM 3.0 compliant image data derived from various sources including CT and MRI.

ResolutionMD™ is intended for use as a diagnostic, review, and analysis tool by trained professionals such as physicians, technologists, and nurses. When interpreted by a trained physician, reviewed images may be used as an element for diagnosis. It is the user's responsibility to ensure that the software is installed on appropriate hardware and that image quality is suitable for the clinical application.

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Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.

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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

SEP 2 2 2006

Mr. Pierre Lemire Chief Technology Officer Calgary Scientific, Inc. Suite 208-1210 20th Avenue SE Calgary, Alberta, T2G 1M8 CANADA

Re: K062164

Trade/Device Name: ResolutionMDTM Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: July 25, 2006 Received: July 28, 2006

## Dear Mr. Lemire:

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 with the letters "FDA" in the center. Above the letters, the numbers "1876-1976" are displayed, and below the letters, the word "Centennial" is written. Three stars are located at the bottom of the circle. The logo appears to be a commemorative emblem for the centennial of the FDA.

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 Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

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 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/cdrl/industry/support/index.html.

Sincerely yours,

Nancy C. Hogdon

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

Applicant: Calgary Scientific, Inc., Suite 208 - 1210 20th Ave. SE, Calgary, Alberta, CANADA T2G 1M8

510(k) Number (if known):

ResolutionMD™M Device Name:

Indications for Use:

ResolutionMD™ is a software based Picture Archiving and Communication System (PACS) used with general purpose computing hardware for the display and 3D visualization of medical image data. It provides for communication, storage, processing, rendering, and display of DICOM 3.0 compliant image data derived from various sources including CT and MRI.

ResolutionMD™ is intended for use as a diagnostic, review, and analysis tool by trained professionals such as physicians, technologists, and nurses. When interpreted by a trained physician, reviewed images may be used as an element for diagnosis. It is the user's responsibility to ensure that the software is installed on appropriate hardware and that image quality is suitable for the clinical application.

Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ X (Part 21 CFR 801 Subpart D)

ADD/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

David C. Lyymm

Division of Reproductive, Abdon and Radiological Devices 510(k) Number _

Confidential