PHILIPS VIEWFORUM 2003

K032096 · Philips Medical Systems · LLZ · Jul 18, 2003 · Radiology

Device Facts

• Record ID: K032096
• Device Name: PHILIPS VIEWFORUM 2003
• Applicant: Philips Medical Systems
• Product Code: LLZ · Radiology
• Decision Date: Jul 18, 2003
• 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

ViewForum 2003 is an image processing workstation software package designed to run on standard PC hardware. The hardware required is made up of "off-the-shell" standard computer components. ViewForum 2003 software receives image data from medical scanning devices such as CT and MRI, or from image archives. It performs viewing, image manipulation, communication, printing and quantification of images.

Device Story

Software-based image processing workstation; runs on off-the-shelf PC hardware. Inputs: medical image files from scanning devices (CT, MRI) or archives. Functions: viewing, manipulation, communication, printing, and quantification of images. Facilitates interoperability via DICOM standard. Used in clinical environments; operated by healthcare professionals. Output: processed images and quantitative data for clinical review. Benefits: enables diagnostic review and analysis of medical imaging data.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Software package for standard PC hardware; DICOM-compliant for network communication; supports image viewing, manipulation, and quantification. No specific hardware materials or energy sources defined as it utilizes off-the-shelf components.

Indications for Use

Indicated for use by clinicians to view, manipulate, communicate, print, and quantify medical images received from scanning devices (e.g., CT, MRI) or image archives.

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

• Philips EasyVision Workstation (K920950)
• Philips EasyVision Workstation Release 6 (K023137)

Submission Summary (Full Text)

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K032096

Image /page/0/Picture/1 description: The image shows the Philips logo. The logo consists of the word "PHILIPS" in bold, sans-serif font, positioned above a shield-like emblem. The emblem features a stylized representation of radio waves and a star-like symbol, enclosed within a thick border.

# PHILIPS

### Philips Medical Systems

JUL 1 8 2003

## 510 (k) Summary

Philips ViewForum 2003

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

I General Information

| Company Name: | Philips Medical Systems North America Company |
|----------------------|----------------------------------------------------------------------------|
| Address: | 22100 Bothell Everett Highway 98021-8431<br>Bothell Washington<br>USA |
| Contact Person | Lynn T. Harmer |
| Telephone Number: | 425-478-7312 |
| Prepared (date): | June 4, 2003 |
| Device Name: | Philips ViewForum 2003 |
| Classification Name: | System, Image Processing |
| Regulation number | 892.2050 |
| Classification: | Class: II |
| ProCode: | 90 LLZ |
| Common/Usual Name: | Workstation |
| Predicate Devices: | Philips EasyVision Workstation<br>Philips EasyVision Workstation Release 6 |

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#### II Information Supporting Substantial Equivalence Determination

#### System Description:

The device is a software package able to run on "off the shelf" hardware components.

The basic functions of ViewForum 2003 are viewing, printing, storing, communications, transferring and quantifying images. The incorporation of the DICOM standard for medical network protocols transfers, an interface between the various system components and information exchange is facilitated, this provides compatibility with diagnostic imaging systems, printers, archival and review stations from many manufacturers.

The product will also be made available as a Plug-in version for use on other modality Workstations such as CT, PACS etc. which use suitable Hardware components.

#### Intended Use:

The product is an image processing workstation software package designed to run on standard PC hardware. The hardware is all "off-the-shelf" standard computer components and may be purchased independently by the end user or supplied by Philips. The ViewForum 2003 software receives image files from medical scanning devices, such as CT or MRI, or from image archives and performs viewing, image manipulation, communication and printing and quantification of images.

#### Safety information:

No new hazards are introduced by the development of ViewForum 2003. Hazards known during the lifecycle of the predecessor Easy Vision Workstation are again considered and measurements are taken.

#### Substantial equivalence:

The Philips ViewForum 2003 is substantially equivalent to the EasyVision Workstation systems (K920950) and Easy Vision Workstation Release 6 (K023137.)

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its wings. The eagle is facing left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 8 2003

Philips Medical Systems North America Company % Mr. Marc M. Mouser Project Engineer/Program Reviewer Underwriters Laboratories, Inc. 2600 NW Lake Road CAMAS WA 98607

Re: K032096 Trade/Device Name: ViewForum 2003 Image Processing System Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: July 7, 2003 Received: July 8, 2003

Dear Mr. Mouser:

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 (PMA), it may be subject to 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 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 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 Office of Compliance at [phone]. 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 may be obtained 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 vours.

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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510(k) Number (if known): Device Name: Indications For Use:

0320 '6

ViewForum 2003, Image Processing System

ViewForum 2003 is an image processing workstation software package designed to run on standard PC hardware. The hardware required is made up of "off-the-shell" standard computer components. ViewForum 2003 software receives image data from medical scanning devices such as CT and MRI, or from image archives. It performs viewing, image manipulation, communication, printing and quantification of images.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number K032091

Prescription Use | (Per 21CFR 801.109)

OR

Over-The-Counter Use