PLATINUM READING, REVIEW & ANALYSIS WORKSTATION

K981217 · GE Medical Systems · LLZ · Jun 18, 1998 · Radiology

Device Facts

• Record ID: K981217
• Device Name: PLATINUM READING, REVIEW & ANALYSIS WORKSTATION
• Applicant: GE Medical Systems
• Product Code: LLZ · Radiology
• Decision Date: Jun 18, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

The PLATINUM Image Reading, Review & Analysis Workstation is an image display workstation that is intended for use by qualified physicians for reading, reviewing and analyzing computerized digital images and reports acquired from imaging devices such as CT, MRI or computed radiography systems. PLATINUM is used to view digital images which are obtained either from a GE PACS System or a DICOM device, i.e. Acquisition, Archive or Workstation.

Device Story

PLATINUM Reading, Review & Analysis Workstation is a medical image display system for radiologists. It receives digital image data from GE PACS systems or DICOM-compliant acquisition/archive devices. The workstation allows physicians to view, review, and analyze these images to assist in clinical diagnosis. It is intended for use in clinical environments by qualified physicians. The device functions as a display and analysis platform, enabling the interpretation of diagnostic images to support clinical decision-making and patient care.

Clinical Evidence

Bench testing only. The device was evaluated for compliance with electrical safety (UL 1950/IEC 950) and electromagnetic compatibility (IEC 60601-1-2) standards. No clinical data provided.

Technological Characteristics

Medical image display workstation. Components include video display monitors and ROM. Complies with UL 1950/IEC 950 (Information Technology Equipment) and IEC 60601-1-2 (EMC). Supports DICOM connectivity for image acquisition from PACS or other DICOM devices.

Indications for Use

Indicated for use by qualified physicians to read, review, and analyze computerized digital images and reports from CT, MRI, or computed radiography systems.

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

• GE Medical Systems PACS Image Display Workstations
• GE Medical Systems Image Acquisition Workstations
• GE Medical Systems Network Storage Products
• GE Medical Systems PACS LiteBox
• GE Medical Systems Advantage Windows Review Workstation
• ISG Technologies' ISG Viewing and Reading Stations (VRS)
• ISG Silhouette Radiology Application

Submission Summary (Full Text)

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## JUN 1 8 1998

# SUMMARY OF SAFETY AND EFFECTIVENESS

#### I. General Information

Classification Name:

Common/Usual Name:

Device Trade Name:

Classification:

Anatomical Region: Intended Uses: Diagnostic Uses:

Establishment Name and Address:

Establishment Registration Number:

Performance Standards:

PACS (Picture. Archival and Communications System) Workstations

PACS (Picture. Archival and Communications System) Workstations

PLATINUM Reading, Review & Analysis Workstation

FDA has proposed a classification for PACS (Picture Archiving and Communication System) as Class II in 21CFR 892.2050.

All areas Image Review

GE Medical Systems 3000 N. Grandview Blvd. Waukesha, WI 53188

2126677

No applicable performance standards for this device have been issued under Section 514 of the Federal Food, Drug and Cosmetic Act. However, the video display monitors which are components of the system comply with applicable standards for television receivers and appropriate submissions have been filed with CDRH in accordance with the Radiation Control Health and Safety Act. The ROM components of the system comply with 21CFR, Subchapter J - Radiological Health. All workstation components are evaluated for compliance with Information Technology Equipment Standards (UL 1950/IEC 950) by a nationally recognized testing laboratory (NRTL) and so Listed. The device also complies with the standard for EMC -IEC 60601-1-2.

### II. Safety and Effectiveness Information Supporting the Substantial Equivalence Determination

#### General Safety and Effectiveness Concerns:

The device labeling contains instructions for use. It includes indications for use and cautions. This information assures safe and effective use of the device.

#### Substantial Equivalence:

The PLATINUM Reading, Review & Analysis Workstation is a medical image display workstation intended to assist radiologists in making diagnoses. The intended use and technological characteristics are similar to the GE Medical Systems PACS Image Display Workstations, Image Acquisition Workstations, and Network Storage Products, GE Medical Systems PACS LiteBox, GE Medical Systems Advantage Windows Review Workstation, and ISG Technologies' ISG Viewing and Reading Stations (VRS), and ISG Silhouette Radiology Application products.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 8 1998

Larry A. Kroger, Ph.D. Regulatory Affairs Program Manager GE Medical Systems P.O. Box 414 Milwaukee, WI 53201

Re:

K981217 Platinum Reading, Review and Analysis Workstation Dated: April 2, 1998 Received: April 3, 1998 Regulatory class: II 21 CFR 892.2050/Procode: 90 LLZ

Dear Dr. Kroger:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 revisions of the Rederal Food, Drug, and Cosmetic Act (Act). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Fecteral Regulations, Title 21, Parts 800 to 895. A substantially equivaliation assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drue Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address "http://www.fda.gov/odri/dsmaldsmam.html".

Sincerely yours,

Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throa 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: PLATINUM Reading, Review & Analysis Workstation

Indications For Use:

The PLATINUM Image Reading, Review & Analysis Workstation is an image display workstation that is intended for use by qualified physicians for reading, reviewing and analyzing computerized digital images and reports acquired from imaging devices such as CT, MRI or computed radiography systems. PLATINUM is used to view digital images which are obtained either from a GE PACS System or a DICOM device, i.e. Acquisition, Archive or Workstation.

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| | Concurrence of CDRH, Office of Device Evaluation (ODE) |
|--|--------------------------------------------------------|
|--|--------------------------------------------------------|

| (Division Sign-Off) |
|-----------------------------------------------------------------------|
| Division of Reproductive, Abdominal, ENT,<br>and Radiological Devices |

| 510(k) Number | K981217 |
|---------------|---------|
|---------------|---------|

| Prescription Use<br>(Per 21 CFR 801.109) | OR | Over-The-Counter Use |
|------------------------------------------|----|----------------------|
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