(7 days)
Not Found
No
The summary describes a standard PACS system for image storage, display, and workflow, with no mention of AI or ML capabilities. The algorithms mentioned are for image format conversion (JPEG and wavelet), which are not AI/ML.
No.
This device is designed for image storage, display, and workflow integration for medical images, not for treating or diagnosing medical conditions.
No
The device is described as a PACS system designed for image storage, display, and workflow integration for viewing by clinicians, not for providing medical diagnoses.
Yes
The device is described as an "integrated client-server software package" that "may be marketed as software only" and uses "standard 'off-the-shelf' PC hardware." This indicates the core medical device functionality resides solely in the software, relying on commercially available, non-medical device hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is focused on image storage, display, and workflow integration for medical images (specifically DICOM images). This is related to the management and viewing of diagnostic images, not the performance of tests on biological samples.
- Device Description: The device is described as a PACS (Picture Archiving and Communication System) device. PACS systems are used for managing and distributing medical images, which is distinct from in vitro diagnostic testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory tests. The focus is entirely on the handling and display of medical images.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device's function is centered around the images themselves, not the analysis of biological samples.
N/A
Intended Use / Indications for Use
The system is designed to provide image storage, display, and workflow integration capabilities for radiologists as well as image reviewing workgroup physicians and other clinicians. In addition to traditional 2D image viewing functionality, the image display system provides advanced 3D features including volume rendering and multi-planar reconstruction designed to function in web-enabled viewers over both local and wide area networks.
Product codes
LLZ
Device Description
UltraVisual Vortex™ is an integrated client-serversoftware package, which may be marketed as software only, that is used in conjunction with standard PC UltraVisual Vortex™ is a PC-based, DICOM-compliant PACS hardware. device that is able to receive, transmit and display DICOM images over both local and wide area network. Images sent to the UltraVisual Vortex™server are converted into formats suitable for viewing in a web browser, and stored in a local cache (hard disk). The algorithms used by UltraVisual Vortex™to create JPEG and wavelet images follow known and accepted protocols.
Vortex™ can be used within a hospital, a managed care facility or an isolated imaging center. It can also be used for image distribution over the network for teleradiology/review purpose.
UltraVisual Vortex™ uses standard "off-the-shelf" PC hardware and communicates using the standard TCP/IP stack.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
DICOM 3.0
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
radiologists, referring physicians, medical technologists, and information technology professionals.
Can be used within a hospital, a managed care facility or an isolated imaging center.
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)
Extensive testing of the software package has been performed by programmers, by non-programmers, quality control staff, and by potential customers.
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
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
Koi 2097
JUL 1 2 2001
510(k) SUMMARY
In accordance with the provisions of the Safe Medical Device Act of 1990, UltraVisual Medical Systems is providing a summary of safety and effectiveness information regarding the Vortex™ software.
1.1 Company Identification
UltraVisual Medical Systems 131 W. Wilson Street Suite 700 Madison WI 53703 Tel: 608 256 7775 Fax: 608 256 7779 Email: icouture@ultravisual.com
-
1.2 Official Correspondent
Gary J. Allsebrook Regulatory Management Services 16303 Panoramic Way San Leandro, CA, USA, 94578-1116 Tel: 510-276-2648 Fax: 510-276-3559 Email: regman1@home.com -
1.3 Date of Submission
June 13, 2001
1.4 Device Name
| Classification Name: | Image Processing System, 21 CFR
§892.2050, ProCode LLZ |
|----------------------|-----------------------------------------------------------|
| Common/Usual Name: | Teleradiology System |
| Proprietary Name: | Vortex™ |
1
Substantial Equivalence 1 .5
The UltraVisual Vortex™ software is substantially equivalent to the Voxar Plug 'n View, K992654 and the AMICAS Web/Intranet Image Server, K970064).
Device Description and Intended Use 1.6
UltraVisual Vortex™ is an integrated client-serversoftware package, which may be marketed as software only, that is used in conjunction with standard PC UltraVisual Vortex™ is a PC-based, DICOM-compliant PACS hardware. device that is able to receive, transmit and display DICOM images over both local and wide area network. Images sent to the UltraVisual Vortex™server are converted into formats suitable for viewing in a web browser, and stored in a local cache (hard disk). The algorithms used by UltraVisual Vortex™to create JPEG and wavelet images follow known and accepted protocols.
Vortex™ can be used within a hospital, a managed care facility or an isolated imaging center. It can also be used for image distribution over the network for teleradiology/review purpose.
UltraVisual Vortex™ uses standard "off-the-shelf" PC hardware and communicates using the standard TCP/IP stack.
1.7 Software Development
Ultravisual certifies that the Vortex™ software is designed, developed, tested and validated according to written procedures. These procedures identify individuals within the organization responsible for developing and approving product specifications and designs, coding and unit testing, validation testing and field maintenance.
2
Safety and Effectiveness 1.8
General Safety and Effectiveness Concerns:
The device labeling contains instructions for use and indications for use.
The hardware components specified (and/or optionally supplied) are all "off the shelf" computer components.
Validation and Effectiveness:
Extensive testing of the software package has been performed by programmers, by non-programmers, quality control staff, and by potential customers.
Substantial Equivalence:
The Ultravisual Vortex™ software is an integrated client-server software package used to receive DICOM images, convert them to an internal format, and to transfer those converted images to a viewing client.
Ultravisual Vortex™ has Indications for Use similar to other medical image devices such asAMICAS Web/Intranet Image Server (K970064) and Voxar Plug-n-View (K992654). VortexTM also shares with these devices a Target Population that is competent healthcare professionals.
Like the AMICAS Web/Intranet Image Server (K970064) product, VortexTM receives DICOM images on the server, converts them to wavelet format and displays them within a web enabled application at the client system.
Like the Voxar Plug 'n View (K992654) product, Vortex™ also provides tools for both 2D and 3D visualization of images, such as Volume Rendering, Multi Planar Reformatting (MPR) and Maximum Intensity Projection (MIP).
Any differences between the Ultravisual Vortex™ software and the equivalent devices have no significant influence on safety or effectiveness.
It is our conclusion that there is no software component in the UltraVisual Vortex™product or hardware component which would be used in conjunction with the UltraVisual Vortex™product that we know of whose failure or latent design flaw would be expected to result in death or injury to a patient. Thus the "Level of Concern" of the Ultravisual Vortex™ product is "minor".
3
1.9 Substantial Equivalence Chart
| Product Name | UltraVisual
Vortex™ | AMICAS | Voxar |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|-----------|-----------|
| Windows O.S. - Client | Yes | Yes | Yes |
| Uses Standard. Monitor | Yes | Yes | Yes |
| Scales Image to Display. | Yes | Yes | Yes |
| Image Input | DICOM 3.0 | DICOM 3.0 | DICOM 3.0 |
| Images stored on remote NT
server | Yes | Yes | - |
| Network Protocol | TCP-IP | TCP-IP | TCP-IP |
| Compression | Wavelet/JPEG | Wavelet | - |
| Image Measurement | Yes | Yes | Yes |
| Cine tool | Yes | Yes | Yes |
| Comparison Mode | Yes | Yes | Yes |
| Flip / Rotate of Images | Yes | Yes | Yes |
| Patient & Study Browser | Yes | Yes | Yes |
| Volume Rendering | Volume rendering with
interactive opacity/
transparency control,
clipping volume of interest
(VOI), zoom, pan and rotate | - | Same |
| Multi-Planar Reformatting
(MPR) | MPR into any user-defined
linear plane. | - | Same |
| Maximum Intensity
Projection (MIP) | MIP with interactive
window-level, clipping
VOI, zoom, pan and rotate | - | Same |
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three lines representing its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 2 2001
UltraVisual Medical Systems % Mr. Mark Job TUV Product Service, Inc. 1775 Old Highway 8 NEW BRIGHTON MN 55112 Re: K012097
Vortex (TELERADIOLOGY SYSTEM) Dated: July 2, 2001 Received: July 5, 2001 Regulatory Class: II 21 CFR 892.2050/Procode: 90 LLZ
Dear Mr. Job:
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 legally marketed predicate 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, 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 practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (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 requirements, 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 does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product 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) 594-4639. Additionally, for questions on the promotion 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" (21CFR 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/dsma/dsmamain.html".
Sincerely yours.
Nancy C.Bogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure (s)
5
Kol 2097 510(k) Number (if known):
Ultra Visual Medical Systems, Vortex™ Image Processing, Device Name: Communication and Visualization Workstation
Indications For Use:
The system is designed to provide image storage, display, and workflow integration The system is designed to provises. The image display architecture provides capabilities for neartheare capabilities for radiologists as well as image reviewing workgroup didgiostly froming capass and other clinicians. In addition to traditional 2D image viewing functionality, the image display system provides advanced 3D features including volume rendering and multi-planar reconstruction designed to function in web-enabled viewers over both local and wide area networks.
Intended users of the image distribution system include radiologists, referring nhended ason of the mage sicians, medical technologists, and information technology professionals.
(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 901.109)
OR
Over-the-Counter Use
(Optional Format 1-2-96)
David Li. Hyam
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K012097