VOXAR 3D PRODUCT FAMILY

K043194 · Voxar Limited · LLZ · Jan 11, 2005 · Radiology

Device Facts

• Record ID: K043194
• Device Name: VOXAR 3D PRODUCT FAMILY
• Applicant: Voxar Limited
• Product Code: LLZ · Radiology
• Decision Date: Jan 11, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device, 3rd-Party Reviewed

Intended Use

The Voxar 3D product family is a suite of products that is intended to provide Physicians, Clinicians and Radiologists with tools to aid them in reading and interpreting DICOM compliant tomographic medical imaging. The Voxar 3D product family provides several levels of functionality to the user .- Basic analysis tools they use on a daily basis, such as 2D review, orthogonal . multi planar reconstructions (mpr's), oblique mpr's, curved / cross - curved MPR's, slab MPR's AveiP, MIP, MinIP, measurements, annotations, reporting, distribution, etc. Tools for in depth analysis, such as segmentation, enescopic review, colour VR . slab, 3D volume review, path definition and boundary detection, PET imagery analysis, etc Specialist tools and workflow enhancements for specific clinical applications . which provide targeted workflows, custom UI, targeted measurement and reporting functions including colon Screening (which is intended for the screening of patients for colonic polyps, tumours and other lesions using tomographic Colonography), calcium scoring (which is intended for non - invasive identification and quantification of calcifieatherosclerotic plaques in the coronary arteries using tomographic medical image data and clinically accepted calcium scoring algorithms), Vessel analysis (which is intended for the qualative and quantative analysis of tomographic angiographic studies to evaluate occlusive and aneurysmal disease), etc

Device Story

Voxar 3D is a software suite for DICOM tomographic image analysis; used by radiologists and clinicians in clinical settings. Inputs include DICOM-compliant tomographic images (CT, PET, etc.). Device performs 2D review, multi-planar reconstructions (MPR), volume rendering (VR), segmentation, and boundary detection. Specialist modules provide targeted workflows for colon screening, coronary calcium scoring, and vessel analysis. Output consists of processed images, measurements, and reports displayed on a workstation. These tools assist clinicians in identifying lesions, quantifying calcification, and evaluating vascular disease, facilitating diagnostic decision-making and patient management.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use as a diagnostic imaging software tool.

Technological Characteristics

Software-based image processing suite. Operates on DICOM-compliant tomographic data. Features include 2D/3D visualization, MPR, segmentation, and automated measurement tools. Connectivity via standard DICOM protocols. No specific hardware materials or energy sources defined as it is a software-only device.

Indications for Use

Indicated for use by physicians, clinicians, and radiologists to aid in reading and interpreting DICOM-compliant tomographic medical images. Includes specific applications for colon screening (polyps, tumors, lesions), coronary artery calcium scoring (calcified atherosclerotic plaques), and vessel analysis (occlusive and aneurysmal disease).

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).

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 1 2005

Voxar Ltd. % Mr. Jeff Rongero Senior Project Engineer Underwriters Laboratories, Inc. 12 Laboratory Drive P.O. Box 13995 Research Triangle Park, NC 27709 Re: K043194 Trade/Device Name: Voxar 3D Product Family Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: December 17, 2004 Received: December 27, 2004

Dear Mr. Rongero:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced n ove 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 redy 20, 11 is 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 registements 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.

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.

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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 premated 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.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" (21 CFR 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/cdrh/dsma/dsmamain.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

# Applicant:

Voxar Ltd, Bonnington Bond, 2 Anderson Place, Edinburgh, EH6 5NP, UK

## 510(k) Number (if known):

Unknown RU4 3194

#### Device Name:

Voxar 3D Product Family

### Indications For Use:

The Voxar 3D product family is a suite of products that is intended to provide Physicians, Clinicians and Radiologists with tools to aid them in reading and interpreting DICOM compliant tomographic medical imaging.

The Voxar 3D product family provides several levels of functionality to the user .-

- Basic analysis tools they use on a daily basis, such as 2D review, orthogonal . multi planar reconstructions (mpr's), oblique mpr's, curved / cross - curved MPR's, slab MPR's AveiP, MIP, MinIP, measurements, annotations, reporting, distribution, etc.
- Tools for in depth analysis, such as segmentation, enescopic review, colour VR . slab, 3D volume review, path definition and boundary detection, PET imagery analysis, etc
- Specialist tools and workflow enhancements for specific clinical applications . which provide targeted workflows, custom UI, targeted measurement and reporting functions including colon Screening (which is intended for the screening of patients for colonic polyps, tumours and other lesions using tomographic Colonography), calcium scoring (which is intended for non - invasive identification and quantification of calcifieatherosclerotic plaques in the coronary arteries using tomographic medical image data and clinically accepted calcium scoring algorithms), Vessel analysis (which is intended for the qualative and quantative analysis of tomographic angiographic studies to evaluate occlusive and aneurysmal disease), etc

× Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Lynn

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(Division Sign-Off)
Division of Reproductive. Abdominal,
and Radiological Devices
510(k) Submission Page C1
510(k) Number K043194