SIENET MAGICWEB (WEB SERVER), SIENET MAGICLINK I (ISI-GATEWAY)

K973131 · Siemens Medical Solutions USA, Inc. · LMD · Nov 12, 1997 · Radiology

Device Facts

• Record ID: K973131
• Device Name: SIENET MAGICWEB (WEB SERVER), SIENET MAGICLINK I (ISI-GATEWAY)
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: LMD · Radiology
• Decision Date: Nov 12, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2020
• Device Class: Class 1
• Attributes: Software as a Medical Device

Intended Use

The SIENET MagicWeb and MagicLink I are medical communication devices (gateway devices). The MagicWeb is a web server intended to provide lowend image and report distribution. Images and reports can be viewed by accessing the server using commercially available Web Browsers. Images distributed by the MagicWeb are for viewing purposes and are not intended for primary diagnosis. The MagicLink I is a gateway connection between SIENET and RIS/HIS systems. Patient demographic information and examination data (text only) are transferred across the gateway. This device is an accessory to hospital information systems.

Device Story

SIENET gateway product line consists of MagicWeb (web server) and MagicLink I (RIS/HIS gateway). MagicWeb inputs medical images and reports; transforms them for distribution via web browsers; outputs viewable images/reports for clinical reference; not for primary diagnosis. MagicLink I inputs/outputs patient demographic data and examination text; acts as interface between SIENET and hospital information systems (RIS/HIS). Used in clinical environments; operated by hospital staff. Facilitates information access and workflow integration; benefits patient care through improved data availability.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Gateway devices supporting DICOM 3.0, HL7, GIF, and JPEG formats. MagicWeb functions as a web server for browser-based viewing. MagicLink I provides interface connectivity between SIENET and RIS/HIS systems. Connectivity via standard network protocols.

Indications for Use

Indicated for use as a medical image and data communication gateway within hospital information systems to facilitate the distribution of images, reports, and patient demographic data. Not intended for primary diagnostic use.

Regulatory Classification

Identification

A medical image communications device provides electronic transfer of medical image data between medical devices. It may include a physical communications medium, modems, and interfaces. It may provide simple image review software functionality for medical image processing and manipulation, such as grayscale window and level, zoom and pan, user delineated geometric measurements, compression, or user added image annotations. The device does not perform advanced image processing or complex quantitative functions. This does not include electronic transfer of medical image software functions.

Predicate Devices

• Siemens: SIENET SPI Import/Export Spooler (K953522)
• Mitra Imaging: HIS-SCP (Mitra Broker)
• PixeLinks: FreePix/PixPACS (K970174)
• Autocytgroup: Amicas Web Intranet Image Server (K970064)

Submission Summary (Full Text)

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# SIEMENS

# k973131 Attachment K: 510(k) Summary

## 510(k) Summary

NOV 1 2 1997

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

- GENERAL INFORMATION I.
Establishment:

| • Address: | Siemens Medical Systems, Inc.<br>186 Wood Avenue South<br>Iselin, NJ 08830 |
|------------|----------------------------------------------------------------------------|
|------------|----------------------------------------------------------------------------|

- 2240869 . Registration Number:
Kathleen Rutherford Contact Person: ● Manager, Regulatory Submissions [phone], Telefax: [phone] after December 1, 1997: [phone], Telefax: [phone]

Device Name:

- SIENET Gateway product line: ● Trade Name: MagicWeb and MagicLink I
- On November 17, 1996, FDA proposed classi-Classification: . fications for five Medical Image Management Devices. One classification was defined as Medical Image Communications Device (Sec. 892.2020). This type of device was defined as Class I exempt from premarket notifications requirements only when the devices transfers images without performing irreversible or lossy compression. The SIENET gateway products that are described in this premarket notification fall within the definition of a Medical Image Communications Devices (as defined by FDA in its classification proposal.
- Performance Standards: None established under Section 514 of the Food, ● Drug, and Cosmetic Act

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# SIEMENS

## II. SAFETY AND EFFECTIVENESS INFORMATION SUPPORTING THE SUBSTANTIAL EQUIVALENCE DETERMINATION

#### Device Description and Intended Use: .

This premarket notification covers the SIENET gateway product line, specifically, SIENET MagicLink I (ISI-Gateway) and MagicWeb (web server).

The SIENET MagicWeb and MagicLink I are medical communication devices (gateway devices). The MagicWeb is a web server intended to provide low-end image and report distribution. Images and reports can be viewed by accessing the server using commercially available Web Browsers. Images distributed by the MagicWeb are for viewing purposes and are not intended for primary diagnosis.

The MagicLink I is a gateway connection between SIENET and RIS/HIS systems. Patient demographic information and examination data (text only) are transferred across the gateway. This device is an accessory to hospital information systems.

These products support industry standard information transmission and communication protocols.

#### Technological Characteristics: ●

The MagicWeb described supports DICOM 3.0, GIF, and JPEG. The MagicLink I supports DICOM 3.0 and HL7 via an OEM interface.

#### . General Safety and Effectiveness Concerns:

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

#### . Substantial Equivalence:

The SIENET gateway products, addressed in this premarket notification, are substantially equivalent to the following commercially available devices:

- Siemens: SIENET SPI Import/Export Spooler [K953522]
- . Mitra Imaging: HIS-SCP (Mitra Broker)
- PixeLinks: FreePix/PixPACS [K970174]
- Autocytgroup: Amicas Web Intranet Image Server [K970064] .

The SIENET gateway products described in this 510(k) have the same intended use and similar technical characteristics as the devices listed above.

Kathleen Rutherford
Signature

8/20/92
Date

## 510(k) Premarket Notification

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Image /page/2/Picture/17 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged around the logo.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## NOV 1 2 1997

Amy Shaw Hosler Senior Technical Specialist Siemens Medical Systems 186 Wood Avenue South Iselin, NJ 08830

Re: K973131

Sienet Magic Web and MagicLink I Dated: August 19, 1997 Received: August 21, 1997 Regulatory class: Unclassified Procode: 90 LMD

Dear Ms. Hosler:

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 that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, subject to the general controls provisions of 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 requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug 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 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/cdrh/dsmamain.html".

Sincerely yours.

W.Liliau Yu
Lillian Yin, Ph.D.

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

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CONFIDENTA

510(k) Number (if known): Device Name: _________________________________________________________________________________________________________________________________________________________________

### Indications for Use:

The SIENET MagicWeb and MagicLink I are medical communication devices (gateway devices). The MagicWeb is a web server intended to provide lowend image and report distribution. Images and reports can be viewed by accessing the server using commercially available Web Browsers. Images distributed by the MagicWeb are for viewing purposes and are not intended for primary diagnosis.

The MagicLink I is a gateway connection between SIENET and RIS/HIS systems. Patient demographic information and examination data (text only) are transferred across the gateway. This device is an accessory to hospital information systems.

Concurrence of the CDRH, Office of Device Evaluation (ODE)

Lórid C. de yorm
(Division Sign off)

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

510(k) Number K973131

Prescription Use OR Over-the-counter Use