THE NETWORK SYSTEM

K980234 · Medical Sni , Ltd. · LLZ · Jun 17, 1998 · Radiology

Device Facts

• Record ID: K980234
• Device Name: THE NETWORK SYSTEM
• Applicant: Medical Sni , Ltd.
• Product Code: LLZ · Radiology
• Decision Date: Jun 17, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The Network System is intended to provide electronic management of the acquisition, storage, distribution and review of Medical Images. Management activities include: Acquisition: the Network System from all medical modalities and digitized films. Storage: archive is managed by a database. Distribution: and wide area networks based on standard TCP protocols. Review: Reading Station (MMRS), the primary diagnostic reading station. The reading station has all necessary functions to enable full Radiological interpretation Images.

Device Story

The Network System is a Picture Archiving and Communication System (PACS) designed for medical institutions. It manages medical images by acquiring data from various medical modalities and digitized films; storing images in a database-managed archive; and distributing images across local and wide area networks using standard TCP protocols. The system includes a primary diagnostic reading station (MMRS) equipped with functions for full radiological interpretation. Physicians and radiologists use the MMRS to review images, which facilitates efficient medical record handling and supports clinical decision-making by providing timely access to diagnostic imaging.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

PACS architecture; utilizes standard TCP protocols for network distribution; database-managed archive; primary diagnostic reading station (MMRS) for image interpretation; supports input from medical modalities and digitized films.

Indications for Use

Indicated for electronic management of medical images, including acquisition, storage, distribution, and review for radiological interpretation in medical institutions.

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)

{0}------------------------------------------------

JUN 17 1998

# SUMMARY OF SAFETY AND EFFECTIVENESS

This summary of safety and effectiveness information is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807 92.

# Submitter: Medical SNI Ltd. POB 25370 Haifa ISRAEL tel. [phone]

Name of the Device: The Network System.

# Description of the Device:

and Communication System (PACS). The system is intended to computerize Medical Image handling in Medical institutions. The computerization of the Medical records improves the efficiency of Medical Record handling and thus has a positive effect on Medical practice.

The Network System is intended to provide electronic management of the acquisition, storage, distribution and review of Medical Images.

# Acquisition

the Network System from all medical modalities and digitized films.

## Storage

archive is managed by a database.

## Distribution

and wide area networks based on standard TCP protocols.

# Review

Reading Station (MMRS), the primary diagnostic reading station. The reading station has all necessary functions to enable full Radiological interpretation Images.

The Network System is shown schematically in the figure below:

Image /page/0/Figure/20 description: The image shows a diagram with four boxes connected by arrows and a horizontal line. The top left box is labeled "Input Data Digital Modalities", and the top right box is labeled "Input Data Digital X - Ray". The bottom left box is labeled "Archive", and the bottom right box is labeled "MMRS". The arrows indicate the flow of data between the boxes.

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, resembling a bird-like shape.

ి ప్రాథమిక
శాశాల

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

す

JUN 1 7 1998

Eli M. Orbach, Ph.D. International Regulatory Consultants Medical SNI LTD POB 6718, ERFRAT 90435 ISRAEL Re:

K980234 The Network System (Picture archiving and communications system Dated: May 28, 1998 Received: June 1, 1998 Regulatory class: II 21 CFR 892.2050/Procode: 90 LLZ

Dear Dr. Orbach:

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 provisions of the Federal 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 Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) 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 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/cdr/dsmaldsmamain.html".

Sincerely vours

sincerely yours,

Lillian Yin, Ph.D.

Director, Division of Reproductive Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

ﺘ

Page_ of_

510(k) Number (if known) K980234

Device Name The Network System

Indications For Use:

The Network System is intended to provide electronic management of the acquisition, storage, distribution and review of Medical Images. Management activities include:

## Acquisition

the Network System from all medical modalities and digitized films.

## Storage

archive is managed by a database.

#### Distribution

and wide area networks based on standard TCP protocols.

#### Review

ਗਈ ਹੈ।
ਬਹੁਤੀ
ਸਾਰਨ

Reading Station (MMRS), the primary diagnostic reading station. The reading station has all necessary functions to enable full Radiological interpretation Images.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David C. Segerson
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT and Radiological Dey

510(k) Number KY80234

OR

Prescription Use (Per 21 CFR 801.109)

Over The Counter Use

(Optional Format 1-2-96)