K063505 · Biotex, Inc. · LLZ · Dec 12, 2006 · Radiology
Device Facts
Record ID
K063505
Device Name
VISUALASE ENVISION SOFTWARE SYSTEM
Applicant
Biotex, Inc.
Product Code
LLZ · Radiology
Decision Date
Dec 12, 2006
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 892.2050
Device Class
Class 2
Attributes
Software as a Medical Device
Indications for Use
The Visualase ENVISION workstation is intended to retrieve, store, process, and display temporally dynamic magnetic resonance (MR) data from compatible scanners. The software is capable of analyzing either temporal changes in image intensity as is useful in, for example, dynamic contrast enhancement studies, or temporal changes in complex phase of image data as is useful in, for example, in phase contrast angiography or in determinations of dynamic phase changes related to temperature changes in soft tissues. The image data may be manipulated and viewed in a number of different ways and the value of data at certain selected points may be monitored and/or displayed over time. When interpreted by a trained physician, this device provides information that may be useful in the determination or assessment of a diagnosis, intervention, or course of treatment. Patient management decisions should not be made solely on the basis of Visualase ENVISION analysis.
Device Story
Visualase ENVISION is a PC-based Linux workstation for near real-time analysis of dynamic MRI data. It retrieves image files from compatible MRI scanners via Ethernet. Software functions include image transport, processing, and display. Processing involves analyzing temporal changes in voxel intensity (e.g., contrast uptake/washout) or complex phase angle (e.g., phase contrast angiography, temperature-related phase changes). The system uses proton-resonance-frequency (PRF) shift analysis and image subtraction. Output consists of processed images and parametric data, visualized and manipulated by the user. Used in clinical settings by physicians to assist in diagnosis and treatment assessment. It provides supplemental information to support clinical decision-making; not for sole reliance in patient management.
Clinical Evidence
No clinical data. Bench testing only. Performance verified through technical evaluation of data processing, image representation (32-bit depth), and artifact mitigation strategies (full complex-phase-difference implementation).
Technological Characteristics
PC-based Linux workstation; Ethernet connectivity to MRI host. Uses 32-bit float/integer representation for computation; lossless X-windows Pixmap (XPM) format for display. Processing includes PRF shift analysis and complex-phase-difference implementation. Compatible with GE Signa MR scanners (LX or EXCITE formats).
Indications for Use
Indicated for use by trained physicians to retrieve, store, process, and display dynamic MR data for assessment of diagnosis, intervention, or treatment. Applicable to patients undergoing dynamic contrast enhancement studies, phase contrast angiography, or soft tissue temperature monitoring via MR imaging.
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
Advantage Windows Workstation with FuncTool option (K960265)
Submission Summary (Full Text)
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Kilo3505
JEC 1 2 2006
# 510(k) Summary
In accordance with the Safe Medical Devices Act of 1990 and in compliance with 21CFR 807, the following serves as the 510(k) Summary information upon which the substantial equivalence determination is based.
# Contact Information
| Submitter: | BioTex, Inc.<br>8058 El Rio St.<br>Houston, TX 77054 |
|-----------------|------------------------------------------------------|
| Phone: | 713.741.0111 |
| Contact Person: | Matthew Fox |
| Date Prepared: | 11/15/2006 |
#### Device Names
| Trade/Proprietary Name: | Visualase ENVISION Software System |
|-------------------------|---------------------------------------------|
| Common Name: | MRI Analysis Software |
| Classification: | Picture Archiving and Communications System |
| Product Code: | LLZ: Image Processing System |
| Reg. Class: | Class II |
| Reg. Number: | 21CFR892.2050 |
# Predicate Device
GE Medical Systems:
Advantage Windows Workstation with FuncTool option (K960265).
#### Description of Device
The Visualase ENVISION platform consists of a PC-based Linux workstation running the ENVISION software tools in an X-windows environment. The device uses a standard Ethernet connection to retrieve image data files from a compatible MRI scanner host. The images may be retrieved as soon as they have been stored on the MRI host, facilitating near real-time analysis of dynamic MRI data.
The Visualase ENVISION software tools perform three primary functions: 1) Image transport, 2) Image processing, and 3) Data display. The Image transport tools negotiate communication with the MRI scanner host, determine the availability of images, facilitate retrieval of image files, facilitate local storage of image files, and notify Image processing tools of new data. The Image processing tools extract relevant data from available MR images and update data analysis information. The Data display tools provide visualization and facilitate manipulation of the data extracted by the Image processing tools.
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Data may be processed to display dynamic changes in voxel intensity as a function of image acquisition. Such analysis is useful in analyzing the uptake and washout of MR contrast agents and can be useful for discrimination of tissue type or state. When data from compatible sequences is available, images may also be processed to extract the complex phase angle of voxels as a function of image acquisition. Using protonresonance-frequency (PRF) shift analysis and image subtraction, changes in complex phase angle may be related back to relative changes in temperature during the study.
The Visualase ENVISION software is compatible with General Electric Signa model MR scanners and can be configured to operate with either LX or EXCITE format images.
## Indications for Use
The Visualase ENVISION workstation is intended to retrieve, store, process, and display temporally dynamic magnetic resonance (MR) data from compatible scanners. The software is capable of analyzing either temporal changes in image intensity as is useful in, for example, dynamic contrast enhancement studies, or temporal changes in complex phase of image data as is useful in, for example, in phase contrast angiography or in determinations of dynamic phase changes related to temperature changes in soft tissues. The image data may be manipulated and viewed in a number of different ways and the value of data at certain selected points may be monitored and/or displayed over time. When interpreted by a trained physician, this device provides information that may be useful in the determination or assessment of a diagnosis, intervention, or course of treatment. Patient management decisions should not be made solely on the basis of Visualase ENVISION analysis.
### Comparison to Predicate Device
Attachment 4 of this submission contains substantial equivalence table of comparison. The tables compare the indications and technological features of the Visualase ENVISION Software System and the predicate device.
Addition of supplemental information to those images extracted from MR temporal datasets has previously been given 510(k) clearance in General Electric's Advantage Windows Workstation with FuncTool option (K960265). Similar to FuncTool, Visualase ENVISION software allows analysis of temporal MRI datasets, and displays data similar to the former's parametric images formulated from user supplied functions, image difference functions (including phase difference), and mapping of specified color ramps onto images.
# Technical Performance
#### Computation:
The Visualase ENVISION software system uses 32-bit float or integer representations (as appropriate) to manipulate data. Raw, processed, and computed images are converted to lossless X-windows Pixmap (XPM) format for display and for transfer between applications. Data loss from repeated calculations is unlikely because all output images are re-computed directly from transferred data. For example, when image "contrast" is adjusted by the user, the resulting image is generated based on transformation of the original input data and not relative to the previous output data. Data loss from image representation is unlikely since input images have 16 bits-per-pixel depth and representations used for computation are 32-bits deep.
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#### Artifacts:
The most likely source of artifacts from the ENVISION analysis software is the appearance of "phase breaks" in phase difference images due to imperfect phase unwrap during difference calculation. The likelihood of phase breaks occurring during phase difference images is minimized by using both real and imaginary MR images as inputs and by utilizing a full complex-phase-difference implementation for sequential image differencing (as is implemented in the ENVISION software). If phase breaks or unexpected changes in phase do occur, they are most likely due to 1) extremely long echo times (TE) during a gradient echo sequence, or 2) motion of the subject under study during the acquisition. Motion of the image subject may lead to other artifacts as well. As is always the case in MR imaging, techniques for minimizing motion during the scanning sequence should be observed.
#### Conclusion
BioTex has demonstrated the Visualase ENVISION Software System is substantially equivalent to the predicate device based on design, technical performance, and indications for use.
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" in a circular arrangement. The text is in all capital letters and is evenly spaced around the circular border of the logo.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Mr. Matthew Fox Engineering Manager BioTex, Inc. 8058 El Rio St. HOUSTON TX 77054
DEC 1 2 2006
Re: K063505
Trade/Device Name: Visualase ENVISION Workstation Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: November 15, 2006 Received: November 21, 2006
Dear Mr. Fox:
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/3/Picture/10 description: The image is a circular logo with the letters "FDA" in large, bold font in the center. Above the letters, the years "1906 - 2006" are printed. Below the letters, the word "Centennial" is written in cursive. Three stars are located below the word "Centennial". The logo is surrounded by a dotted border.
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 that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (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) 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), please contact the Office of Compliance 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" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division 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. Bogdon
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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# Indications for Use Statement
KO63505 510(k) Number (if known):
Device Name:
Indications for Use:
The Visualase ENVISION workstation is intended to retrieve, store, process, and display temporally dynamic magnetic resonance (MR) data from compatible scanners. The software is capable of analyzing either temporal changes in image intensity as is useful in, for example, dynamic contrast enhancement studies, or temporal changes in complex phase of image data as is useful in, for example, in phase contrast angiography or in determinations of dynamic phase changes related to temperature changes in soft tissues. The image data may be manipulated and viewed in a number of different ways and the value of data at certain selected points may be monitored and/or displayed over time. When interpreted by a trained physician, this device provides information that may be useful in the determination or assessment of a diagnosis, intervention, or course of treatment. Patient management decisions should not be made solely on the basis of Visualase ENVISION analysis.
PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE
Prescription Use
David A. Symon
(Division Sign-Off Division of Reproductive. Abdomi 510/k) Number
Visualase ENVISION 510(k) Submission
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.
