(67 days)
Not Found
No
The document describes a standard PACS workstation for storing, communicating, processing, and displaying medical images, with no mention of AI or ML capabilities.
No.
The device is used for storing, communicating, processing, and displaying medical images, not for treating any medical condition.
No
The device is described as a general-purpose computer system and software used to store, communicate, process, and display radiological images and data. It receives images from various sources but does not indicate any diagnostic interpretation or analysis of these images. Its function is to facilitate the viewing and management of images by trained professionals, not to provide a diagnosis itself.
No
The device description explicitly states it is a "general purpose computer system consisting of a computer (console, display, keyboard, and mouse) and software," indicating it includes hardware components in addition to the software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The Olicon 02-Workstation and/or PACSView™ Software is described as a system for receiving, storing, communicating, processing, and displaying digital images and data from various medical imaging sources (CT, MR, Ultrasound, etc.).
- Lack of Biological Sample Analysis: There is no mention of the device analyzing biological samples or performing tests on bodily fluids or tissues. Its function is centered around handling and displaying medical images.
Therefore, while it is a medical device used in a clinical setting, its purpose aligns with medical imaging and information management, not with in vitro diagnostic testing.
N/A
Intended Use / 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.
Product codes
LMD
Device Description
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT Scanners, MR Scanners, Ultrasound systems, R/F Units, Computed & Direct Radiographic devices, secondary capture devices, scanners, imaging gateways, or other imaging sources
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Typical users of this system are trained professionals, including but not limited to physicians, nurses and medical technicians.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2020 Medical image communications device.
(a)
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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.
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: (714) 360-1830 (714) 362-1522 fax:
Trade Name, Common Name, Classification: [21 CFR 807.92(a)(2)]
| Trade Name: | Olicon 02 Workstation and/or PACSView
software |
|----------------------|---------------------------------------------------|
| Common Name: | Digital Imaging Workstation |
| Classification Name: | System, Digital Image Communication,
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 (301) 594-4613. Additionally, for question and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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
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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)