OLICON IMAGING SYSTEMS, INC. GATEWAY AND/OR SOFTWARE

K973793 · Olicon Imaging Systems, Inc. · LMD · Dec 17, 1997 · Radiology

Device Facts

• Record ID: K973793
• Device Name: OLICON IMAGING SYSTEMS, INC. GATEWAY AND/OR SOFTWARE
• Applicant: Olicon Imaging Systems, Inc.
• Product Code: LMD · Radiology
• Decision Date: Dec 17, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2020
• Device Class: Class 1

Intended Use

The Olicon Gateway is a uni-directional device that receives digital images and data from various image sources, (including but not limited to CT Scanners, MR Scanners, Ultrasound systems, R/F Units, Computed & Direct Radiographic devices, secondary capture devices, imaging gateways, or other imaging sources). The incoming data formats are ACR-NEMA v2.0, DICOM, or SPI (Standard Product Interconnect) or proprietary to the modality source vendor. The Olicon Gateway, converts the imaging or other data into DICOM, ACR-NEMA v2.0, SPI (Standard Product Interconnect) or proprietary data format and transmits the data to one or more user specified locations across a standard general purpose computing network. Typical users of this system are trained professionals, including but not limited to physicians, nurses and medical technicians.

Device Story

Olicon Gateway is a general-purpose computer system acting as a communications protocol converter; it receives digital images and demographic data from various imaging modalities (CT, MR, Ultrasound, etc.). The system re-formats incoming data (ACR-NEMA v2.0, DICOM, SPI, or proprietary) into target formats (DICOM, ACR-NEMA v2.0, SPI, or proprietary) and automatically routes them to predefined network destinations. Operated by trained medical professionals in clinical environments, the device does not perform permanent image storage or contact patients. It serves as a bridge for image communication; output is interpreted by clinicians to support decision-making. The device benefits patients by enabling efficient image distribution across hospital networks.

Clinical Evidence

Bench testing only. No clinical data provided. Compliance with UL-1950 safety standards for information technology equipment is documented.

Technological Characteristics

General-purpose computer system (console, display, keyboard, mouse) running protocol conversion software. Functions as a communications protocol converter; not a permanent storage device. Connectivity via standard general-purpose computing networks. Complies with UL-1950 safety standards. Password-protected access control.

Indications for Use

Indicated for trained professionals (physicians, nurses, technicians) to facilitate digital image and data transfer from various imaging sources (CT, MR, Ultrasound, R/F, Radiographic) to specified network locations via protocol conversion.

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

• IMAGESHARE PROTOCOL CONVERTING GATEWAY AND/OR SOFTWARE (K963592)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows a sequence of handwritten digits and a letter. The sequence starts with the letter 'K', followed by the numbers '973793'. The numbers are written in a simple, slightly irregular style, typical of handwriting.

DEC 17 1997

Image /page/0/Picture/2 description: The image shows a logo with the text "OKICON" in large, bold letters. Below "OKICON" is the text "IMAGING SYSTEMS, INC." in a smaller font. The logo is set against a black background, with the text appearing in white.

# 5 1 0(k) Summary of Safety and Effectiveness

[as required by 21 CFR 807.92©]

Date Prepared: [21 CFR 807.92(a)(1)]

20 September, 1997

### Submitter's Information: [21 CFR 807.92(a)(1)]

Olicon Imaging Systems, Inc. 120 Columbia Avenue, Suite 600 Aliso Viejo, CA 92656 phone: [phone] fax:

## Trade Name, Common Name, Classification: [21 CFR 807.92(a)(2)]

| Trade Name: | Olicon Gateway |
|----------------------|------------------------------------------------|
| Common Name: | Gateway to Digital Imaging Network |
| Classification Name: | System, Digital Image Communication, accessory |

## Predicate Device: [21 CFR 807.92(a)(3)

| Applicant: | DEJARNETTE RESEARCH SYSTEMS |
|----------------|-----------------------------------------------------------|
| 510(k) Number: | K963592 |
| Device: | IMAGESHARE PROTOCOL CONVERTING<br>GATEWAY AND/OR SOFTWARE |

## Device Description: [21 CFR 807.92(a)(4)]

The Olicon Gateway system is a general purpose computer system consisting of a computer (console, display, keyboard, and mouse) and software which runs a protocol conversion software application that uses defined configuration to receive, reformat, and transmit images and demographic information. The system is capable of receiving images from different sources and routes them automatically to predefined destinations.

## Indications for Use: [21 CFR 807.92(a)(5)]

The Olicon Gateway is a uni-directional device that receives digital images and data from various image sources, (including but not limited to CT Scanners, MR Scanners, Ultrasound systems, R/F Units, Computed & Direct Radiographic devices, secondary capture devices, imaging gateways, or other imaging sources).

The incoming data formats are ACR-NEMA v2.0, DICOM, or SPI (Standard Product Interconnect) or proprietary to the modality source vendor. The Olicon Gateway, converts the imaging or other data into DICOM, ACR-

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NEMA v2.0, SPI (Standard Product Interconnect) or proprietary data format and transmits the data to one or more user specified locations across a standard general purpose computing network. Typical users of this system are trained professionals, including but not limited to physicians, nurses and medical technicians.

### Technological Characteristics: [21 CFR 807.92(a)(6)]

The Olicon Gateway system is a general purpose computer system consisting of a computer (console, display, keyboard, and mouse) and software which runs a protocol conversion software application that uses defined configuration to receive, reformat, and transmit images and demographic information. It functions as a communications protocol converter and not as a permanent image store device. The system is capable of receiving images from different sources and routes them automatically to predefined destinations.

## Performance Data: [21 CFR 807.92(b)(1)]

The subject and predicate devices both use standard data communications controls to detect and correct errors.

The subject device complies with UL-1950 Standard for Safety of Information Technology Equipment, Including Electrical Business Equipment.

## Conclusion: [21 CFR 807.92(b)(1)]

Similar to the predicate device, the Olicon Gateway does not contact the patient, nor does it control any life sustaining devices. Images and information being relayed and or transmitted are interpreted by a physician or trained medical personnel, providing ample opportunity for competent human intervention.

The subject device and the predicate share the same certification of conformance to UL-1950 and both function as a communications protocol converter to relay and transmit images and data from different modalities and sources to specified locations. Device failures which might result in partial or failed transmissions may be recovered by re-transmission after correcting the problems. Passwords are required for operation and to protect against unauthorized use of the system.

We conclude that the subject devices are safe, effective and substantially equivalent to the predicate device.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 17 1997

Olicon Imaging Systems, Inc. c/o Herman Oosterwijck Otech, Inc. 6741 Grant Avenue Plano, Texas 75024

Re:

K973793 Protocol Converting Network Gateway Dated: September 20, 1997 Received: October 6, 1997 Regulatory class: Unclassified Procode: 90 LMD

Dear Mr. Oosterwijck:

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 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 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 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,

W.Liau 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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## 510(k) Number:

Device Name: Olicon Imaging Systems, Inc. - Gateway

### Indications For Use:

The Olicon Gateway is a uni-directional device that receives digital images and data from various image sources, (including but not limited to CT Scanners, MR Scanners, Ultrasound systems, R/F Units, Computed & Direct Radiographic devices, secondary capture devices, imaging gateways, or other imaging sources).

The incoming data formats are ACR-NEMA v2.0, DICOM, or SPI (Standard Product Interconnect) or proprietary to the modality source vendor. The Olicon Gateway, converts the imaging or other data into DICOM, ACR-NEMA v2.0, SPI (Standard Product Interconnect) or proprietary data format and transmits the data to one or more user specified locations across a standard general purpose computing network.

Typical users of this system are trained professionals, including but not limited to physicians, nurses and medical technicians.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT(Optional Format 1-2-96)
and Radiological Devices
510(k) Number K973793
Olicon Imaging Systems, Inc. Gateway 510(k)