VOLUME VIEWER PLUS

K041521 · General Electric Medical Systems · JAK · Jun 22, 2004 · Radiology

Device Facts

• Record ID: K041521
• Device Name: VOLUME VIEWER PLUS
• Applicant: General Electric Medical Systems
• Product Code: JAK · Radiology
• Decision Date: Jun 22, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2
• Attributes: Software as a Medical Device, 3rd-Party Reviewed

Intended Use

Volume Viewer Plus is a medical diagnostic software that allows the processing, review, and communication of 3D reconstructed images and their relationship acquired images from CT, MR, X-Ray Angio and PET Scanning devices. The combination of acquired images, reconstructed images, annotations and measurements performed by the clinician are intended to provide to the referring physician clinically relevant information for diagnosis, surgery and treatment planning.

Device Story

Volume Viewer Plus is a software package for GE Advantage Workstation, Centricity PACS, and CT operator consoles. It processes DICOM CT, MR, X-Ray Angio, and PET images. Functionality includes Multi-Planar Reformation (MPR) in orthogonal, oblique, or curved planes; 3D rendering (MIP, MinIP, Average, Volume Rendering, Fly-Through); and correlation with original images. Clinicians use the interface to manipulate, annotate, measure, and record views, and generate exam reports. Features include anatomy segmentation, multi-phase display, and fused hybrid imaging (PET/CT, PET/MR). The software aids referring physicians in diagnosis, surgery, and treatment planning by providing clinically relevant 3D visualizations and quantitative data.

Clinical Evidence

No clinical data. The device relies on software development, validation, and verification processes to ensure performance to specifications and adherence to industry standards.

Technological Characteristics

Software-based medical diagnostic tool for 3D image processing. Operates on GE workstations (Advantage, Centricity PACS, CT consoles). Supports DICOM standard for image input/output. Features include MPR, 3D rendering (MIP, MinIP, Volume Rendering), segmentation, and fused hybrid imaging. Connectivity via standard workstation/PACS network integration.

Indications for Use

Indicated for use by clinicians to process, review, and communicate 3D reconstructed images and original source images from CT, MR, X-Ray Angio, and PET scans for diagnosis, surgery, and treatment planning.

Regulatory Classification

Identification

A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

• Advantage Windows Volume Rendering Option (K972399)
• CT Colonography / Navigator2 (K012313)

Submission Summary (Full Text)

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K041521

JUN 2 2 2004

Image /page/0/Picture/2 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined and enclosed within a circular shape. The letters and the circle are in black, creating a strong contrast. The logo is simple, recognizable, and represents the General Electric brand.

GE Medical Systems

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.87(h).

| Submitter | Larry A. Kroger, Ph.D.<br>Senior Regulatory Programs Manager<br>Tel: [phone]<br>Fax: [phone]<br>GE Medical Systems W-400<br>3000 North Grandview Blvd.<br>Waukesha, WI 53188 USA<br>Date Prepared: March 10, 2004. |
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# PRODUCT IDENTIFICATION

| Name: | Volume Viewer Plus |
|--------------------------------|-------------------------------------------------------------------------------------------------------|
| Classification Name: | Accessory to Computed Tomography System<br>Accessory to Magnetic Resonance diagnostic device |
| Manufacturer : | General Electric Medical Systems<br>283, rue de la Minière<br>78533 Buc Cedex, FRANCE |
| Distributor: | General Electric Medical Systems, Buc, France. |
| Marketed Devices | The Volume Viewer Plus is substantially equivalent to the devices listed below: |
| Model: Manufacturer: 510(k) #: | Advantage Windows Volume Rendering Option<br>General Electric Medical Systems, Buc, France<br>K972399 |

- CT Colonography / Navigator2 Model: .
- General Electric Medical Systems, Buc, France Manufacturer: ● K012313 510(k) #:

# Device Description:

Volume Viewer Plus is a software package to be used on the GE Advantage Workstation, the GE Centricity PACS Workstation and the GE CT Operator Consoles (LightSpeed and HiSpeed). It allows

#### NOMFICHIFR

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the 3D processing, review and analysis of DICOM CT, MR, X-Ray Angio and PET images previously acquired, reconstructed and transferred on the corresponding workstation.

This software provides Multi-Planar Reformation (MPR) views in any plane (orthogonal, oblique or curved), 3D views in any rendering mode (MIP, MinIP, Average, Volume Rendering, Fly-Through) and their correlation to originally acquired images. Its user interface provides the tools to manipulate, annotate, measure and record these views as well as output an exam report. Additional features allow for segmentation of anatomy as well as display of multi-phase and/or fused hybrid images (PET/CT, PET/MR).

# Indications for Use:

Volume Viewer Plus is a medical diagnostic software that allows the processing, review, and communication of 3D reconstructed images and their relationship acquired images from CT, MR, X-Ray Angio and PET Scanning devices. The combination of acquired images, reconstructed images, annotations and measurements performed by the clinician are intended to provide to the referring physician clinically relevant information for diagnosis, surgery and treatment planning.

### Comparison with Predicate:

Volume Viewer Plus is substantially equivalent to the predicate devices listed above and provides additional processing capabilities with standard review protocols per anatomy and acquisition technique (One Touch, Layout Presets, Compare Mode), enhanced segmentation tools (AutoSelect, Multi-Object Volume Rendering), enhanced visualization tools (Fused Display, Dynamic Volume Review, ROI Tool) and finally real-time interactive exporting tools (Batch Reformat/Filming, Movie Builder).

| Device Name | FDA Clearance Number |
|----------------------------------------------|----------------------|
| Advantage Windows Volume Rendering<br>Option | K972399 |
| CT Colonography / Navigator2 | K012313 |

#### Adverse Effects on Health:

The potential hazards are identified in a risk management summary (hazard analysis) and are controlled by:

- · Software Development, Validation and Verification Process to ensure performance to specifications, Federal Regulations and user requirements.
- · Adherence to industry and international standards.

#### Conclusions:

The Volume Viewer Plus does not result in any new potential safety risks and performs as well as devices currently on the market. GE considers features of the Volume Viewer Plus to be equivalent to those of Advantage Windows Volume Rendering Option (K972399) and CT Colonography / Navigator2 (K012313).

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# 'JUN 2 2 2004

General Electric Medical Systems % Mr. Tamas Borsai Program Manager TUV Rheinland of North America 1279 Quarry Lane, Suite A PLEASANTON CA 94566

Re: K041521

Trade/Device Name: Volume Viewer Plus Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 JAK and LNH Dated: June 7, 2004 Received: June 8, 2004

Dear Mr. Borsai:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your boctor. Doctor is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enatebally) it the enactment date of the Medical Device Amendments, or to commerce pror to they 20, 2014 11:47 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 I ou may, merciore, mains of the Act include requirements for annual registration, listing of general controls provisions practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is olassinod (social controls. Existing major regulations affecting your device can may be subject to back access as 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 i hat FDA has made a determination that your device complies with other requirements of the Act that FDA has made a doternmantin that Juni 1978 - 1999 - 1991 - 1991 - 1999 - 1999 - 1999 - 19 or any I odolar statuted and not including, but not limited to: registration and listing (21 CFR Part with an the Ace 3 requirements, measure manufacturing practice requirements as set forth in the 607); laooning (21 CFR Part 820); and if applicable, the electronic product quality systems (QB) regular(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) This letter will anow you to ogen marketing of substantial equivalence of your device to a legally premarket notification. The PDF maining of easification 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 If you desire specific advice for your an of the following numbers, based on the regulation number at the top of the letter:

| 8xx. 1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, for questions on the promote the regulation entitled, "Misbranding Other of Compliance at (2017 97) 97 100 100 100 100 100 100 100 100 100 100 100 by relected to premarket neumoution (er the Act may be obtained from the Division of Small mornlation on your responsional 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. Brydon

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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K04 1521

Image /page/4/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. The logo is in black and white.

General Electric Medical Systems

# STATEMENT OF INDICATION FOR USE

Device name: Volume Viewer Plus

### Indication for Use:

510(k) Number _

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
21 CFR 801.109)
-OR-
Over-The-Counter Use (Per

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
jerome Browsing 16 Apr 2004

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