K012097 · Ultravisual Medical Systems · LLZ · Jul 12, 2001 · Radiology
Device Facts
Record ID
K012097
Device Name
VORTEX
Applicant
Ultravisual Medical Systems
Product Code
LLZ · Radiology
Decision Date
Jul 12, 2001
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 892.2050
Device Class
Class 2
Attributes
Software as a Medical Device, 3rd-Party Reviewed
Indications for Use
The system is designed to provide image storage, display, and workflow integration capabilities for radiologists as well as image reviewing capabilities for other clinicians. The image display architecture provides capabilities for near-real-time viewing of images and other diagnostic data. 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 physicians, medical technologists, and information technology professionals.
Device Story
Vortex™ is an integrated client-server software package for teleradiology and image review; operates on standard off-the-shelf PC hardware. Inputs: DICOM 3.0 images received over TCP/IP networks. Processing: server converts DICOM images to JPEG/wavelet formats for web-browser viewing; stores images in local cache. Outputs: 2D/3D image visualizations (Volume Rendering, MPR, MIP) displayed on standard monitors. Used in hospitals, managed care facilities, or imaging centers by radiologists, clinicians, and technologists. Healthcare providers use the system to review images, perform measurements, and conduct 3D reconstructions to assist in clinical decision-making and image distribution.
Clinical Evidence
Bench testing only. Software validated through internal procedures involving programmers, non-programmers, quality control staff, and potential customers. No clinical data provided.
Technological Characteristics
Client-server software architecture; runs on standard off-the-shelf PC hardware. Connectivity: TCP/IP network protocol. Image formats: DICOM 3.0 input; JPEG/wavelet output. Visualization: 2D tools (cine, measurement, flip/rotate) and 3D tools (Volume Rendering, MPR, MIP). Software-based image processing.
Indications for Use
Indicated for use by radiologists, referring physicians, medical technologists, and IT professionals for the storage, display, and workflow integration of medical images. Supports 2D viewing and 3D visualization (volume rendering, MPR, MIP) via web-enabled viewers over local and wide area networks.
Regulatory Classification
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.
Special Controls
*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).
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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<br>§892.2050, ProCode LLZ |
|----------------------|-----------------------------------------------------------|
| Common/Usual Name: | Teleradiology System |
| Proprietary Name: | Vortex™ |
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### 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.
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#### 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".
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### 1.9 Substantial Equivalence Chart
| Product Name | UltraVisual<br>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<br>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<br>interactive opacity/<br>transparency control,<br>clipping volume of interest<br>(VOI), zoom, pan and rotate | - | Same |
| Multi-Planar Reformatting<br>(MPR) | MPR into any user-defined<br>linear plane. | - | Same |
| Maximum Intensity<br>Projection (MIP) | MIP with interactive<br>window-level, clipping<br>VOI, zoom, pan and rotate | - | Same |
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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)
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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
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
