PHILIPS EASYVISION WORKSTATION RELEASE 6

K023137 · Philips Medical Systems North America Co. · LLZ · Dec 19, 2002 · Radiology

Device Facts

• Record ID: K023137
• Device Name: PHILIPS EASYVISION WORKSTATION RELEASE 6
• Applicant: Philips Medical Systems North America Co.
• Product Code: LLZ · Radiology
• Decision Date: Dec 19, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The EasyVision Workstation Release 6 is an image processing workstation software package designed to run on standard PC hardware. The hardware required is made up of "off-the-shelf" standard computer components. The Easy Vision Workstation Release 6 software receives image data from medical scanning devices, such as CT or MRI, or from image archives and 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 data from CT/MRI scanners or archives. Functions: viewing, image manipulation, communication, printing, and quantification. Used in clinical environments by healthcare professionals. Output: processed medical images and quantitative data for clinical review and decision-making. Facilitates diagnostic assessment by providing tools for image analysis and management.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Software package for off-the-shelf PC hardware; Windows XP Professional OS; DICOM protocol communication over TCP/IP network; functions include viewing, printing, storage, and linking.

Indications for Use

Indicated for use by clinicians to view, manipulate, communicate, print, and quantify medical image data 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)

Submission Summary (Full Text)

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K023137

Philips Medical Systems

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# S

DEC 1 9 2002

## 510 (k) Summary

Philips "EasyVision Workstation Release 6"

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

| 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): | September 18, 2002 |
| Device Name: | Philips EasyVision Workstation Release 6 |
| Classification Name: | System, Image Processing |
| Regulation number | 892.2050 |
| Classification: | Class:<br>II |
| ProCode: | 90 LLZ |
| Common/Usual Name: | Workstation |
| Predicate Devices: | Philips EasyVision Workstation |

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#### Information Supporting Substantial Equivalence Determination II

#### System Description:

The device is a software package able to run on "off the shelf" hardware components. The system operating software is a standard Windows XP Professionel operating system. The application software can be divided in view, print, store and link functions. Communication with modalities such as MRI and CT and with archive systems, operates via a standardised DICOM protocol on top of a TCP/IP network.

#### Intended Use:

The product is an image processing workstation software package designed to run on standard PC hardware. The hardware required is made up of "off-the-shelf" standard computer components. The Easy Vision Workstation Release 6 software receives image data from medical scanning devices, such as CT or MRI, or from image archives and performs viewing, image manipulation, communication, printing and quantification of images.

#### Safety information:

No new hazards are introduced by the development of Easy Vision Workstation Release 6. Hazards known during the lifecycle of the Easy Vision Workstations are again considered and measurements are taken.

#### Substantial equivalence:

The Philips Easy Vision Workstation Release 6 is substantially equivalent to the Easy Vision Workstation systems (K920950).

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of three human profiles facing right, stacked on top of each other, with flowing lines below them.

Public Health Service

DEC 1 9 2002

od and Drug Administra 200 Corporate Boulevard Rockville MID 20850

Mr. Lynn T. Harmer Manager, Regulatory Submissions Philips Medical Systems North America Company 22100 Bothell Everett Highway BOTHELL WA 98021-8431

#### Re: K023137

Trade/Device Name: Philips Easy Vision Workstation Release 6 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ

Dated: September 19, 2002 Received: September 20, 2002

Dear Mr. Harmer:

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 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:

| 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" (21 CFR Part 807.97). 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 yours,

Nancy C. Snogdon

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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### X02 3137

510(K) Number (if known): ____________________________________________________________________________________________________________________________________________________

EasyVision Workstation Release 6 Device Name:

Indications for Use:

The EasyVision Workstation Release 6 is an image processing workstation software package designed to run on standard PC hardware. The hardware required is made up of "off-the-shelf" standard computer components. The Easy Vision Workstation Release 6 software receives image data from medical scanning devices, such as CT or MRI, or from image archives and 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)

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use _

Daniel A. Sigg

(Division Sign-Off) Division of Reproductive, Abdominal, Division of Reproductive, Abdominal
and Radiological Devices KO2331

(Optional Format 1-2-96)