OLICON IMAGING SYSTEMS, INC. 02-WORKSTATION AND/OR PACSVIEW SOFTWARE

K973959 · Olicon Imaging Systems, Inc. · LMD · Dec 22, 1997 · Radiology

Device Facts

• Record ID: K973959
• Device Name: OLICON IMAGING SYSTEMS, INC. 02-WORKSTATION AND/OR PACSVIEW SOFTWARE
• Applicant: Olicon Imaging Systems, Inc.
• Product Code: LMD · Radiology
• Decision Date: Dec 22, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2020
• Device Class: Class 1

Intended Use

The Olicon 02-Workstation and/or PACSView™ Software is a 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, scanners, imaging gateways, or other imaging sources). Images/data can be stored, communicated, processed, and displayed within the workstation and or across computer networks at distributed locations. Typical users of this system are trained professionals, including but not limited to physicians, nurses and medical technicians.

Device Story

Olicon 02-Workstation and PACSView software function as digital imaging workstations; receive digital images/data from various sources (CT, MR, Ultrasound, R/F, Radiographic devices); store, communicate, process, and display images on high-resolution monitors using Intel Pentium-based computer systems; operated by trained professionals (physicians, nurses, technicians) in clinical settings; facilitate review and interpretation of radiological data; support clinical decision-making through human interpretation of displayed images; provide network-based image distribution; include password protection for security.

Clinical Evidence

Bench testing only. No clinical data provided. Device safety supported by compliance with UL-1950 standard for electrical information technology equipment and use of standard data communication protocols for error detection/correction.

Technological Characteristics

General purpose computer system (console, display, keyboard, mouse) using Intel Pentium processors; Microsoft Windows NT or 95 operating systems; DICOM 3.0 compliant; UL-1950 certified; password-protected access.

Indications for Use

Indicated for trained professionals, including physicians, nurses, and medical technicians, to store, communicate, process, and display digital radiological images and data received from various imaging sources (e.g., CT, MR, Ultrasound, R/F, Radiographic devices) across distributed networks.

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

• RAYTEL DIGITAL IMAGING SYSTEMS (K922164)

Submission Summary (Full Text)

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

Image /page/0/Picture/1 description: The image shows a faint, low-resolution graphic with some text. The text appears to be labels or categories, possibly associated with a chart or table. Due to the image quality, the specific details of the text and the overall content are difficult to discern.

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

[as required by 21 CFR 807.92©]

DEC 22 1997

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

23 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] [phone] fax:

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

| Trade Name: | Olicon 02 Workstation and/or PACSView<br>software |
|----------------------|---------------------------------------------------|
| Common Name: | Digital Imaging Workstation |
| Classification Name: | System, Digital Image Communication,<br>accessory |

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

| Applicant: | OLICON IMAGING SYSTEMS INC. |
|----------------|--------------------------------|
| 510(k) Number: | K922164 |
| Device: | RAYTEL DIGITAL IMAGING SYSTEMS |

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

The Olicon 02-Workstation and/or PACSView™ software is a general purpose computer system consisting of a computer (console, display, keyboard, and mouse) and software which is used to store, communicate, and view radiological images and data in a digital format. Images are stored and displayed utilizing Intel Pentium processing unit with high resolution monitors.

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

The Olicon 02-Workstation and/or PACSView™ Software is a 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, scanners, imaging gateways, or other imaging sources). Images/data can be stored, communicated, processed, and displayed within the workstation and or across computer networks at distributed locations.

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

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 02-Workstation and/or PACSView™ software uses the Microsoft Windows NT or 95 operating systems, (as a minimum & depending upon system configuration), and is basically an update of the current Olicon RAYTEL Digital Imaging System Workstation (K922164), and is DICOM 3.0 compliant.

## 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 Business Equipment. Including Electrical Information Technology Equipment.

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

Similar to the predicate device, the Olicon 02-Workstation and/or PACSView™ software does not contact the patient, nor does it control any life sustaining devices. Images and information being reviewed, processed, 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 Digital Imaging Workstations. Device failures which might result in partial or failed transmissions, images, and or data may be recovered by re-transmission after correcting the problems. Passwords are required for operation and to protect against unauthorized use of the system.

Based on the information supplied in this 5109(k), we conclude that the subject devices are safe, effective and substantially equivalent to the predicate device.

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

Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized representation of three human profiles facing right, stacked on top of each other. The profiles are rendered in a simple, flowing line. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the central graphic.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 22 1997

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

Re:

K973959 02 - Workstation and PACSView Software Dated: September 23, 1997 Received: October 16, 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 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. 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

h. 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

{3}------------------------------------------------

# Page 1 of -1

#### 1973959 510(k) Number:

Device Name: Olicon Imaging Systems, Inc. - 02-Workstation and/or PACSView™ Software

# Indications For Use:

The Olicon 02-Workstation and/or PACSView™™ Software is a 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, scanners, imaging gateways, or other imaging sources). Images/data can be stored, communicated, processed, and displayed within the workstation and or across computer networks at distributed locations.

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)