VISISHARE IMAGING SYSTEM AND/ OR SOFTWARE, VISISHARE SYSTEM AND/ OR SOFTWARE

K974130 · Dejarnette Research Systems · LMD · Jan 29, 1998 · Radiology

Device Facts

• Record ID: K974130
• Device Name: VISISHARE IMAGING SYSTEM AND/ OR SOFTWARE, VISISHARE SYSTEM AND/ OR SOFTWARE
• Applicant: Dejarnette Research Systems
• Product Code: LMD · Radiology
• Decision Date: Jan 29, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2020
• Device Class: Class 1
• Attributes: Software as a Medical Device

Intended Use

The VisiShare Imaging System and/or Software is a digital imaging viewing system that receives digital images and patient demographic information from various imaging sources. The incoming data formats are standard medical image formats, proprietary image formats, and common nonmedical image formats. The VisiShare allows the operator to manage, view, retrieve and store images, modify image parameters and annotate image for the purposes of radiological interpretation.

Device Story

VisiShare Imaging System is a software-based digital imaging communication system. It accepts medical images and patient demographic data from various imaging modalities or digital networks. The system allows operators to manage, view, retrieve, store, manipulate, and annotate images. It is designed to run on off-the-shelf, general-purpose computing hardware and supports single or multiple monitor configurations. The system uses network and proprietary interfaces to facilitate communication between modular components, which may reside on local or remote machines. It is intended for use by healthcare professionals for radiological interpretation. The output is displayed on a monitor, enabling clinicians to review and interpret diagnostic images to support clinical decision-making.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Software-based digital imaging system designed for off-the-shelf, general-purpose computing hardware. Modular architecture using network and proprietary interfaces for communication. Supports various medical, proprietary, and non-medical image formats. Performance is dependent on network load, hardware computational speed, and display controller performance. Portability across operating systems is a design feature.

Indications for Use

Indicated for use by clinicians to manage, view, retrieve, store, and annotate digital medical images from various imaging sources for the purpose of radiological interpretation.

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

• Magic View 50 Teleradiology System [Siemens]
• RadWorks Medical Imaging Software [Applicare Medical Imaging, B.V.]
• AutoRad [Cemax-Icon]

Submission Summary (Full Text)

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## K974130

## 1. 510(k) Summary

## 510(k) Summary

[As required by 21 CFR 807.92(c)]

#### Submitter Information 1.0

| 1.1 DeJarnette Research Systems<br>401 Washington Avenue Suite 700<br>Towson MD 21204 | 1.2 Contact: | Eric John Finegan |
|---------------------------------------------------------------------------------------|--------------|---------------------|
| | Voice: | +1 (410) 583 - 0680 |
| | Fax: | +1 (410) 583 - 0696 |
| | E-mail: | [e-mail] |

30 October 1997 1.3 Date Prepared:

#### Device Identification 2.0

- VisiShare Imaging System and/or Software 2.1 Trade Name:
- Digital Imaging Communication System 2.2 Common Name:
- System, Digital Image Communication Classification Name: 2.3

#### Predicate Devices 3.0

Magic View 50 Teleradiology System [Siemens]

RadWorks Medical Imaging Software [Applicare Medical Imaging, B.V.]

AutoRad [Cemax-Icon]

#### 4.0 Device Description

- 4.1 Function:
The VisiShare Imaging System is designed to accept images from various modalities or digital image networks and allow the operator to view, retrieve, store and manipulate medical images in a variety of formats.

The VisiShare is a modular system that uses network and proprietary interfaces for communication between the modules. Network interfaces enable the various modules to reside on local or remote machines. System is designed for low-end and high-end systems, supporting single or multiple monitor configurations.

### Physical and Performance Characteristics: 4.2

The VisiShare Imaging System and/or Software is designed to run on off-the-shelf, general purpose computing equipment. The application software is designed for maximum portability across operating systems and hardware platforms. Performance of the application software is primarily a function of network load; secondarily a function of the hardware platform's computational speed and finally the performance of the display controller. Intrinsic performance of the application does not change significantly as it is ported from one operating system to another.

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# EJARNETTE

#### Intended Use: 5.0

The VisiShare Imaging System and/or Software is a digital imaging viewing system that receives digital images and patient demographic information from various imaging sources. The incoming data formats are standard medical image formats, proprietary image formats, and common nonmedical image formats. The VisiShare allows the operator to manage, view, retrieve and store images, modify image parameters and annotate image for the purposes of radiological interpretation.

### 6.0 Statement of Substantial Equivalence:

The VisiShare Imaging System and/or Software is substantially equivalent to the previously marketed devices (as listed above in Part 3) in design, composition, function, intended use, safety and efficacy.

Any differences between the VisiShare Imaging System and/or Software and the predicate devices have no significant influence on safety or efficacy.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines representing the wings and a stylized body.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AN 2 9 1998

Eric John Finegan Regulatory Manager DeJarnette Research Systems, Inc. 401 Washington Avenue, Suite 700 Towson, Maryland 21204

Re:

K974130 Visishare Imaging System and/or Software Dated: October 31, 1997 Received: November 3, 1997 Regulatory class: Unclassified Procode: 90 LMD

Dear Mr. Finegan:

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 stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices 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 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 III (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 (QS) 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. 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 question 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,

h.Jliau Yu
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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## 2. Statement of Indications for Use

Device: VisiShare Imaging System and/or Software

### Statement of Indications for Use

[As required by 21 CFR 801.109]

The VisiShare Imaging System and/or Software is a digital imaging viewing system that receives digital images and patient demographic information from various imaging sources. The incoming data formats are standard medical image formats, proprietary image formats, and common non-medical image formats. The VisiShare allows the operator to manage, view, retrieve and store images, modify image parameters and annotate image for the purposes of radiological interpretation.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. DeYoung

Prescription Use
(Per 21 CFR 801.109) ✓

OR

Over-The-Counter Use

401 Washington Avenue, Suite 700 Towson, Maryland 21204 Tel.: [phone] Fax: [phone]

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