K062328 · Vital Images, Inc. · LLZ · Aug 21, 2006 · Radiology
Device Facts
Record ID
K062328
Device Name
VITREAACCESS, VERSION 1.0
Applicant
Vital Images, Inc.
Product Code
LLZ · Radiology
Decision Date
Aug 21, 2006
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
VitreaACCESS software is intended to be used for remote review of Vitrea2 Software outputs, such as: processing, analysis, communication and media interchange of multidimensional digital images acquired from a variety of imaging devices.
Device Story
VitreaACCESS 1.0 is a medical image processing software designed for remote review of outputs generated by Vitrea2 software. It enables clinicians to access, process, analyze, and communicate multidimensional digital images acquired from various imaging modalities. The device functions as a remote interface, allowing healthcare providers to view and interact with image data processed by the primary Vitrea2 system. By facilitating remote access, it supports clinical workflows where image review is required outside the immediate vicinity of the primary imaging workstation. The device utilizes the DICOM protocol to ensure interoperability and communication with other medical imaging systems. It is intended for prescription use by healthcare professionals to assist in clinical decision-making through the review of diagnostic image data.
Clinical Evidence
Bench testing only. The software was developed, verified, and validated according to internal procedures, including product specifications, coding, testing, and maintenance. A Risk Management Plan was implemented to identify and control potential hazards. No clinical data was required or provided.
Technological Characteristics
Software-based medical image processing system. Operates via DICOM protocol for image communication and media interchange. Designed for remote review of multidimensional digital images. No specific hardware materials or energy sources defined as it is a software-only device.
Indications for Use
Indicated for clinicians requiring remote review, processing, analysis, and communication of multidimensional digital medical images acquired from various imaging devices.
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).
Predicate Devices
VITALConnectTM System (formerly The iConnection System) (K040876)
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# Kot 2328
# 6.0 510(k) Summary
#### Submitter's Name / Contact Person
AUG 2 1 2006
Timothy J. Kappers, MBA, RAC Director, Quality Systems, Regulatory & Clinical Affairs Vital Images, Inc. 5850 Opus Parkway, Suite 300 Minnetonka, MN 55343
### General Information
| Device Trade Name | VitreaACCESS TM 1.0 - Medical Image Processing Software |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Common / Usual Name | System, Image Processing, Radiological |
| Classification | 892.2050 Picture Archiving and Communications System<br>(LLZ; Class II) |
| Identification of<br>Predicate Devices | VITALConnectTM System- formally The iConnection System<br>(K040876)<br>Vital Images, Inc.<br>Vitrea Version 3.9 (K061624)<br>Vital Images, Inc. |
#### Device Description
VitreaACCESS software specifically allows remote review of Vitrea® outputs.
#### Intended Use
VitreaACCESS software is intended to be used for remote review of Vitrea2 Software outputs, such as: processing, analysis, communication and media interchange of multidimensional digital images acquired from a variety of imaging devices.
#### Predicate Device Comparison
VitreaACCESS software and its predicate device allow for the analysis, communication and media interchange of digital images acquired from a variety of acquisition devices. All devices support the DICOM protocol for communication of images with other medical imaging devices.
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## Summary of Studies
The software utilized was developed, tested, and validated according to written procedures. These procedures specify individuals within the organization responsible for developing and approving product specifications, coding, testing, validating and maintenance.
VitreaACCESS software will successfully complete verification testing prior to Beta validation. Software Beta testing/validation will be successfully completed prior to release. In addition, potential hazards have been studied and controlled by a Risk Management Plan.
#### Conclusion
VitreaACCESS software has a similar intended use as the predicate device and has very similar technological characteristics. Minor technological differences do not raise any new questions regarding safety or effectiveness. Thus, VitreaACCESS software is substantially equivalent to the predicate device.
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Image /page/2/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 symbol that resembles an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
# AUG 2 1 2006
Vital Images. Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
Re: K062328
Trade/Device Name: VitreaACCESS™ 1.0 Medical Image Processing Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: August 8, 2006 Received: August 10, 2006
Dear Mr. Job:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (Special Controls) or 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Image /page/2/Picture/10 description: The image is a circular logo with the text "1906 - 2006" at the top. Below the text is the abbreviation "FDA" in large, bold letters. Underneath the abbreviation is the word "Centennial" in a smaller font. There are three stars at the bottom of the logo. The logo appears to be a commemorative emblem for the centennial anniversary of the FDA.
Protecting and Promoting Public Health
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Page 2 -
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please oe advised that I Dri- 3 issualles of a complies with other requirements of the Act that I DA has made a concentrations administered by other Federal agencies. You must of any I coclar statutes and regaranents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CrK Fart 607), favoring (21 CFR Part 800), go CFR Part 820); and If applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) I ins letter with anow you'ls begin mains of substantial equivalence of your device to a legally premits thousand. The PDF mailing of basis on 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), please If you desire specific actives at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology | 240-276-0115 |
|----------------|---------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" Also, prease note the regulation other general information on your responsibilities under (21CTN I at 601.577). 10d may of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150
or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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#### 3.0 Intended Use Statement
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Device Name: VitreaACCESS™ 1.0 Medical Image Processing Software
VitreaACCESS software is intended to be used for remote review of Vitrea2 Software outputs, such as: processing, analysis, communication and media interchange of multidimensional digital images acquired from a variety of imaging devices.
Prescription Use __ X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel A. Searson
Page __ of ___________________________________________________________________________________________________________________________________________________________________
(Division Sign-Off) Division of Reproductive, Abdomina and Radiological Devices 510(k) Number _
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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.
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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.
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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.
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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.
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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.
