DynaCAD is a post-processing software package intended for use in viewing and analyzing magnetic resonance imaging (MRI) studies. DynaCAD supports evaluation of dynamic MR data acquired during contrast administration. DynaCAD automatically registers serial patient image acquisitions to minimize the impact of patient motion, segments and labels tissue types based on enhancement characteristics (parametric image maps), and performs other user-defined post-processing functions (image subtractions, multiplanar reformats, maximum intensity projections). The resulting information can be displayed in a variety of formats, including a parametric image overlaid onto the source image. DynaCAD is designed to provide a reliable means of visualizing the presence and pattern of contrast induced enhancements of MRI data sets. DynaCAD also provides an intervention planning tool (DynaLOC) which assists with MRI guidance of percutaneous interventional procedures. When interpreted by a skilled physician, this device provides information that may be useful in screening, diagnosis, intervention planning and monitoring. DynaCAD can also be used to provide accurate measurements of the diameters, areas, volumes and uptake characteristics of segmented tissues. Patient management decisions should not be made based solely on the results of DynaCAD analysis.
Device Story
DynaCAD V1.0 is a post-processing software package for MRI data; operates on off-the-shelf PC with display station. Inputs: serial MRI image acquisitions; dynamic contrast-enhanced data. Processing: automatic registration to correct patient motion; parametric fitting of pixel signal intensities to segment/classify tissue types; image subtraction; multiplanar reformatting; maximum intensity projections. Output: parametric image maps (overlaid on source images); quantitative measurements (diameters, areas, volumes, uptake characteristics); DynaLOC intervention planning tool for percutaneous procedures. Used in clinical settings by physicians to assist in screening, diagnosis, and monitoring. Provides visual and quantitative data to support clinical decision-making; not intended for sole diagnostic reliance. Benefits: improved visualization of contrast enhancement patterns and guidance for interventional procedures.
Clinical Evidence
Bench testing and clinical dataset validation performed. Software beta testing completed to verify feature requirements. DynaLOC package accuracy verified in a clinical setting using a phantom model for needle placement. No clinical trial data provided.
Technological Characteristics
Software-based image processing system; runs on off-the-shelf PC hardware. Features include automatic image registration, parametric tissue segmentation, and interventional planning tools. Conforms to DICOM standards. Developed per internal procedures, IEC 601-1-4, and ISO 14971 risk management standards.
Indications for Use
Indicated for use by physicians to view and analyze dynamic contrast-enhanced MRI studies for screening, diagnosis, intervention planning, and monitoring. Applicable to patients undergoing MRI procedures requiring tissue segmentation, motion registration, and interventional guidance.
Regulatory Classification
Identification
A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).
Special Controls
*Classification.* Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
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K041286
# JUL 2 1 2004
#### X. Summary of Safety and Effectiveness
## DynaCAD V1.0
#### Company:
MRI Devices Corporation 1515 Paramount Drive Waukesha. WI 53186
### Contact:
Thomas Tynes Manager, Interventional Business Group Phone: 262-524-1402, Ext. 129 Fax: 262-524-1403 Email: tom.tvnes@mridevices.com
### Date Prepared:
17 June 2004
#### Name of Device
Trade Name: DynaCAD™ V1.0 Classification Name: 90 LLZ
#### Predicate Devices
Vital Images, Vitrea 2 (K002519) Voxar Limited, Voxar Plug n' View 3D (K992654) Acculmage, Inc., Acculmage Display Software (K961023) Mirada Solutions Ltd. Fusion 7D (K020546) Siemens Medical Solutions, Siemens BOLD MRI (K984221) GE Medical Systems. GE Advantage With FuncTool Option (K960265) Philips Medical Systems, Philips EasyVision (Quantitative Analysis Option) (K971965) Confirma, Inc., Accent (K013574) Confirma, Inc., CADstream Version 2.0 MRI Image Processing Software (K031779) 3TP, LLC, 3TP Software Option Image Processing Software for MR Devices (K031350) MRI Devices Corporation, Breast Biopsy Coil (K032576) MRI Devices Corporation, MR Biopsy (K010570)
#### Intended Use
DynaCAD is a post-processing software package intended for use in viewing and analyzing magnetic resonance imaging (MRI) studies. DynaCAD V1.0 supports evaluation of dynamic MR data acquired during contrast administration. DynaCAD automatically registers serial patient image acquisitions to minimize the impact of patient motion, segments and labels tissue types based on enhancement characteristics (parametric image maps), and performs other user-defined post-processing functions (image subtractions, multiplanar reformats, maximum intensity projections). The resulting information can be displayed in a variety of formats, including a parametric image overlaid onto the source image. DynaCAD is designed to provide a reliable means of visualizing the presence and pattern of contrast induced enhancements of MRI data sets. DynaCAD also provides an intervention planning tool (DynaLOC) which assists with MRI guidance of percutaneous interventional procedures.
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When interpreted by a skilled physician, this device provides information that may be useful in screening, diagnosis, intervention planning and monitoring. DynaCAD can also be used to provide accurate measurements of the diameters, areas, volumes and uptake characteristics of segmented tissues. Patient management decisions should not be made based solely on the results of DynaCAD analysis.
#### Device Description
DynaCAD image analysis relies on the assumption that pixels having similar MRI signal intensities represent similar tissues. The DynaCAD software simultaneously analyzes the pixel signal intensities from multiple MRI sequences and applies parametric fitting methods to perform tissue segmentation and classification.
The DynaCAD system consists of proprietary software developed by MRI Devices Corporation which is installed on an off-the-shelf personal computer and a monitor configured as a DynaCAD display station.
#### Software Development
The DynaCAD device has been designed, developed, tested and validated according to written procedures. These procedures identify functions within the organization responsible for developing and approving product specification, coding and testing, verification and validation testing, and technical support.
#### Performance
The product has successfully completed the required integration and verification testing. Conformance to the DICOM standard has been achieved. Assessment of the product has been performed throughout the design development process in accordance with internal procedures and IEC 601-1-4. Risk manaqement was performed in accordance with ISO 14971.
#### Clinical Evaluation
Performance testing of the features described in the user manual has been successfully completed utilizing clinical datasets. Software beta testing also has been completed. validating that the requirements for these features have been met. Target accuracy was verified for the DynaLOC package in a clinical setting, using a realistic patient care procedure and placing needles in a phantom.
#### Substantial Equivalence
The intended use, design, and function and performance characteristics for DynaCAD are substantially equivalent to the predicate devices, particularly those from Confirma and 3TP for image analysis and from MRI Devices Corporation for MR guided breast intervention planning. It is the opinion of MRI Devices Corporation. Inc. that DynaCAD raises no new issues of safety and effectiveness as compared to the predicate devices.
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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an abstract caduceus or a bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY = 1 2007
Mr. Thomas E. Tynes Manager, International MRI Business Group MRI Devices Corporation, Inc. 1515 Paramount Drive WAUKESHA WI 53186
Re: K041286
Trade/Device Name: DynaCAD V1.0 Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH and LLZ Dated: June 17, 2004 Received: June 18, 2004
Dear Mr. Tynes:
This letter corrects our substantially equivalent letter of July 21, 2004.
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 (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 (PMA), it may be subject to 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.
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
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Page 2 - Mr. Tynes
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 continue 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 11 you done of Compliance at (240) 276-0120 (see http://www.fda.gov/cdrh/organiz.html#OC for OC organization structure). Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your to promation nonneally (1) { 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/cdrh/dsma/dsmamain.html
Sincerely yours,
David A. Seymour
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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K041286
#### Statement of Indications for Use
510(k) Number (if known):
Device Name:
DynaCAD V1.0
Indications for Use:
DynaCAD is a post-processing software package intended for use in viewing and analyzing magnetic resonance imaging (MRI) studies. DynaCAD supports evaluation of dynamic MR data magination roomand maging (nistration. DynaCAD automatically registers serial patient image acquisitions to minimize the impact of patient motion, segments and labels tissue types based on enhancement characteristics (parametric image maps), and performs other user-defined post-processing functions such as image subtractions, multiplanar reformats, and maximum The resulting information can be displayed in a variety of formats, intensity projections. including a parametric image overlaid onto the source image. DynaCAD is designed to provide inolding a paramethe mass of visualizing the presence and pattern of contrast induced enhancements of a reliable means of vioualleng the property Aided Detection (CAD) system, DynaCAD also with data sets. In addition to boing a sol, which assists with MRI guidance of perculaneous interventional procedures.
When interpreted by a skilled physician, this device provides information that may be useful in when intervention by a online and monitoring. DynaCAD can also be used to scrooming, blughous, intervents of the diameters, areas, volumes and uptake characteristics of segmented tissues in any original, registered, analyzed or reformatted image. Patient segment decisions should not be made based solely on the results of DynaCAD analysis.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFF 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C Brogdon
(Division Sign-C Dision of Reproducti ai Radiological Devices 5 · Ak) Number
510(k) Notification MRI Devices Corporation
17 June 2004
CONFIDENTIAL page 4
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.
