VOXAR 3D ENTERPRISE, MODEL 6.1

K060505 · Barcoview Mis Edinburgh · LLZ · Mar 29, 2006 · Radiology

Device Facts

• Record ID: K060505
• Device Name: VOXAR 3D ENTERPRISE, MODEL 6.1
• Applicant: Barcoview Mis Edinburgh
• Product Code: LLZ · Radiology
• Decision Date: Mar 29, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

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 (MPRs), oblique MPRs, curved/cross-curved MPRs, slab MPRs, AvelP, MIP, MinIP, measurements, annotations, reporting, distribution, etc Tools for in-depth analysis, such as segmentation, endoscopic 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 calcified atherosclerotic plaques in the coronary arteries using tornographic medical image data and clinically accepted calcium scoring algorithms), Vessel Analysis (which is intended for the qualitative and quantitative analysis of tomographic angiographic studies to evaluate occlusive and aneurysmal disease), etc.

Device Story

Voxar 3D Product Family is a software suite for DICOM tomographic image analysis. Inputs: DICOM-compliant tomographic medical images (CT, PET, etc.). Processing: 2D/3D reconstruction (MPR, MIP, MinIP, VR), segmentation, boundary detection, and clinical-specific algorithms (calcium scoring, vessel analysis). Outputs: Visualizations, measurements, annotations, and reports. Used in clinical settings by physicians, clinicians, and radiologists. Assists in diagnostic interpretation, screening, and quantification of pathologies (e.g., colonic lesions, coronary calcification, vascular disease). Enhances workflow through targeted UI and reporting tools.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Software-based image processing suite. Functions include 2D/3D reconstruction (MPR, MIP, MinIP, VR), segmentation, and measurement tools. Operates on DICOM-compliant tomographic data. Connectivity via standard DICOM protocols. No specific hardware or materials specified.

Indications for Use

Indicated for physicians, clinicians, and radiologists to aid in reading/interpreting DICOM tomographic medical images. Includes specific applications: colon screening for polyps/tumors/lesions via colonography; calcium scoring for identification/quantification of coronary artery calcified atherosclerotic plaques; vessel analysis for qualitative/quantitative evaluation of occlusive and aneurysmal disease in angiographic studies.

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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized emblem featuring three abstract shapes resembling birds in flight, arranged in a cascading manner.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 9 2006

Mr. Neil Phillips Quality and Regulatory Manager BarcoView MIS Edinburgh Bonnington Bond, 2 Anderson Place Edinburgh, Lothian, EH6 5NP UNITED KINGDOM

Re: K060505

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: LLZ

Dated: February 23, 2006 Received: February 27, 2006

Dear Mr. Phillips:

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.

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 marketed predicate device results in a classification for your device and thus, permits wour device (o 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/industry/support/index.html.

Sincerely yours.

7. Nancy C. Brigdon

Nancv 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): ROG 0505

Unknown

## 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 (MPRs), oblique MPRs, curved/cross-curved MPRs, slab MPRs, AvelP, MIP, MinIP, measurements, annotations, reporting, distribution, etc
- Tools for in-depth analysis, such as segmentation, endoscopic 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 calcified atherosclerotic plaques in the coronary arteries using tornographic medical image data and clinically accepted calcium scoring algorithms), Vessel Analysis (which is intended for the qualitative and quantitative analysis of tomographic angiographic studies to evaluate occlusive and aneurysmal disease), etc.

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

David R. Lynn
(Division Sign-Off)

Division of Reproductive, Abdominal,
and Radiological Devices K060505
510(k) Number

Prescription Use
(21 CFR 801.109)

OR

Over-The-counter Use