IMNET DICOM NETWORK AGENT

K972366 · Imnet Systems, Inc. · LMD · Sep 23, 1997 · Radiology

Device Facts

• Record ID: K972366
• Device Name: IMNET DICOM NETWORK AGENT
• Applicant: Imnet Systems, Inc.
• Product Code: LMD · Radiology
• Decision Date: Sep 23, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2020
• Device Class: Class 1
• Attributes: Software as a Medical Device

Intended Use

The IMNET DICOM Network Agent is a software device intended for use within the medical imaging environment. The product is a communication tool which facilitates the transfer of medical images from one system to another. Receiving medical images from a DICOM source and transmitting them to another DICOM compatible target, the product is a communication gateway for the DICOM environment.

Device Story

IMNET DICOM Network Agent functions as a software-based communication gateway within medical imaging environments. It receives medical images from a DICOM-compliant source and transmits them to a DICOM-compatible target system. The device acts as a bridge to facilitate interoperability and image transfer between disparate imaging systems. It is intended for use by healthcare professionals in clinical settings where medical imaging data must be moved between systems. By enabling seamless image routing, the device supports efficient clinical workflows, ensuring that diagnostic images are available where needed for clinical decision-making.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Software-based communication gateway; operates within the DICOM standard environment; facilitates network-based image transfer between DICOM-compatible systems.

Indications for Use

Indicated for use within medical imaging environments as a communication gateway to facilitate the transfer of medical images between DICOM-compatible systems.

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.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name arranged in a circular pattern around a symbol. The symbol consists of a stylized caduceus-like design with three wavy lines converging at the bottom.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 3 1997

K972366

William Bain Associate General Counsel Imnet Systems, Inc. 3015 Winward Plaza Winward Fairway II Alphearetta, GA 30202

Re:

Imnet Dicom Network Agent Dated: June 24, 1997 Received: June 25, 1997 Regulatory class: Unclassified Procode: 90 LMD

Dear Mr. Bain:

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 intenstated 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, 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. 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 grovisions, 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,

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

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## EXHIBIT G : USE FORM

Page 1 of 1

510(k) Number (if known): Not assigned yet

Device Name: IMNET® DICOM Network Agent

Indications for Use:

The IMNET DICOM Network Agent is a software device intended for use within the medical imaging environment. The product is a communication tool which facilitates the transfer of medical images from one system to another. Receiving medical images from a DICOM source and transmitting them to another DICOM compatible target, the product is a communication gateway for the DICOM environment.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

1 Prescription Use

OR Over-The-Counter Use

(Per 21 CFR 801.109

(Optional Format 1-2-96)

Thind G. Seymann

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 172366 510(k) Number

IMNET Systems CONFIDENTIAL