FEops HEARTguide™ Simulation Application is indicated for patient-specific simulation of transcatheter left atrial appendage occlusion (LAAO) device implantation during procedural planning. The software performs computer simulation to predict implant frame deformation to support the evaluation for LAAO device size and placement. FEops HEARTguide™ Simulation Application is intended to be used by qualified clinicians in conjunction with the simulated device instructions for use, the patient’s clinical history, symptoms, and other preprocedural evaluations, as well as the clinician’s professional judgment. FEops HEARTguide™ Simulation Application is not intended to replace the simulated device instructions for use for final LAAO device selection and placement. FEops HEARTguide™ Simulation Application is prescription use only.
Device Story
FEops HEARTguide™ Simulation Application is a software-based tool for procedural planning of transcatheter left atrial appendage occlusion (LAAO). Input consists of patient-specific 3D anatomical models. Trained FEops case analysts generate computational models of the patient anatomy and combine them with predefined computational models of specific LAAO devices. The software simulates implant frame deformation post-implantation. Outputs include 3D model visualizations and a PDF report, delivered via the FEops HEARTguide™ ALPACA platform. Clinicians access results via a web browser to assist in LAAO device size and placement evaluation. The device does not replace clinician judgment or manufacturer instructions for use. It benefits patients by providing pre-procedural insights into device-anatomy interaction, potentially optimizing device selection and placement.
Clinical Evidence
The submission included clinical performance data demonstrating validation for the intended use. Methods used were consistent with the design validation of the predicate device, confirming similar performance characteristics.
Technological Characteristics
Software-based simulation device. Operates via computational modeling of patient-specific 3D anatomy and predefined device models. Delivered via web-based viewer. No physical materials. Software version 4.0.0. Class II device, product code QQI.
Indications for Use
Indicated for patient-specific simulation of transcatheter left atrial appendage occlusion (LAAO) device implantation during procedural planning to predict implant frame deformation and support device size/placement evaluation. Intended for use by qualified clinicians in conjunction with clinical history, symptoms, and preprocedural evaluations.
Regulatory Classification
Identification
An interventional cardiovascular implant simulation software device is a prescription device that provides a computer simulation of an interventional cardiovascular implant device inside a patient's cardiovascular anatomy. It performs computational modeling to predict the interaction of the interventional cardiovascular implant device with the patient-specific anatomical environment.
Special Controls
In combination with the general controls of the FD&C Act, the interventional cardiovascular implant simulation software device is subject to the following special controls:
*Classification.* Class II (special controls). The special controls for this device are:(1) Software verification, validation, and hazard analysis, with identification of appropriate mitigations, must be performed, including a full verification and validation of the software according to the predefined software specifications.
(2) Computational modeling verification and validation activities must be performed to establish the predictive capability of the device for its indications for use.
(3) Performance validation testing must be provided to demonstrate the accuracy and clinical relevance of the modeling methods for the intended implantation simulations, including the following:
(i) Computational modeling results must be compared to clinical data supporting the indications for use to demonstrate accuracy and clinical meaningfulness of the simulations;
(ii) Agreement between computational modeling results and clinical data must be assessed and demonstrated across the full intended operating range (
*e.g.,* full range of patient population, implant device sizes and patient anatomic morphologies). Any selection criteria or limitations of the samples must be described and justified;(iii) Endpoints (
*e.g.,* performance goals) and sample sizes established must be justified as to how they were determined and why they are clinically meaningful; and(iv) Validation must be performed and controls implemented to characterize and ensure consistency (
*i.e.,* repeatability and reproducibility) of modeling outputs:(A) Testing must be performed using multiple qualified operators and using the procedure that will be implemented under anticipated conditions of use; and
(B) The factors (
*e.g.,* medical imaging dataset, operator) must be identified regarding which were held constant and which were varied during the evaluation, and a description must be provided for the computations and statistical analyses used to evaluate the data.(4) Human factors evaluation must be performed to evaluate the ability of the user interface and labeling to allow for intended users to correctly use the device and interpret the provided information.
(5) Device labeling must be provided that describes the following:
(i) Warnings that identify anatomy and image acquisition factors that may impact simulation results and provide cautionary guidance for interpretation of the provided simulation results;
(ii) Device simulation inputs and outputs, and key assumptions made in the simulation and determination of simulated outputs; and
(iii) The computational modeling performance of the device for presented simulation outputs, and the supporting evidence for this performance.
{0}
FDA U.S. FOOD & DRUG ADMINISTRATION
November 25, 2025
FEops nv
Franky Dubois
QARA Manager
Technologiepark-Zwijnaarde 122
Gent, 9052
Belgium
Re: K250635
Trade/Device Name: FEops HEARTguide Simulation Application
Regulation Number: 21 CFR 870.1405
Regulation Name: Interventional Cardiovascular Implant Simulation Software Device
Regulatory Class: Class II
Product Code: QQI
Dated: October 17, 2025
Received: October 27, 2025
Dear Franky Dubois:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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K250635 - Franky Dubois
Page 2
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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K250635 - Franky Dubois
Page 3
Sincerely,
Katherine N. Trivedi -S
Digitally signed by Katherine N. Trivedi -S
Date: 2025.11.25 14:58:05 -07'00"
Katherine Trivedi
Assistant Director
DHT2B: Division of Circulatory Support, Structural, and Vascular Devices
OHT2: Office of Cardiovascular Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
{3}
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.
510(k) Number (if known)
K250635
Device Name
FEops HEARTguide™ Simulation Application
Indications for Use (Describe)
FEops HEARTguide™ Simulation Application is indicated for patient-specific simulation of transcatheter left atrial appendage occlusion (LAAO) device implantation during procedural planning.
The software performs computer simulation to predict implant frame deformation to support the evaluation for LAAO device size and placement.
FEops HEARTguide™ Simulation Application is intended to be used by qualified clinicians in conjunction with the simulated device instructions for use, the patient’s clinical history, symptoms, and other preprocedural evaluations, as well as the clinician’s professional judgment.
FEops HEARTguide™ Simulation Application is not intended to replace the simulated device instructions for use for final LAAO device selection and placement.
Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (6/20)
Page 1 of 1
PSC Publishing Services (301) 443-6740
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FEops nv
Page 1 of 5
510(k) Summary
1.1 Submitter
Company Name: FEops nv
Establishment registration number: 3020703662
Address: Technologiepark-Zwijnaarde 122, 9052 Gent, Belgium
Phone number: +32492501951
Principal contact person: Franky Dubois
Principal contact e-mail address: franky.dubois@materialise.be
Additional contact person: Peter Mortier
Additional contact e-mail address: peter.mortier@materialise.be
Summary date: October 3, 2025
1.2 Device
Name & trade name: FEops HEARTguide™ Simulation Application
Classification name: Interventional Cardiovascular Implant Simulation Software Device
1.3 Predicate Device
The predicate device to which substantial equivalence is claimed:
| Item | Description |
| --- | --- |
| Device Classification Name | Interventional Cardiovascular Implant Simulation Software Device |
| Premarket notification number | K214066 |
| Trade or proprietary or model name | FEops HEARTguide |
| Original Applicant | FEops nv |
| Regulation Number | 870.1405 |
| Decision date | February 25, 2022 |
| Classification product code | QQI |
| Classification Panel | Cardiovascular |
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FEops nv
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## 1.4 Description and functioning of the device
FEops HEARTguide™ Simulation Application predicts implant frame deformation after percutaneous LAAO device implantation through computer simulation. The predicted deformation provides additional information during LAAO procedural planning.
The information provided by FEops HEARTguide™ Simulation Application is intended to be used by qualified clinicians in conjunction with the simulated device instructions for use, the patient's clinical history, symptoms, and other preprocedural evaluations, as well as the clinician's professional judgment.
The customer (clinician) does not interact with the simulation software directly. The simulations are performed by trained FEops case analysts through an established workflow. Based on a patient-specific 3D model of the anatomy, a computational model of the anatomy is generated and combined with a predefined computational model of the device.
The simulation results are delivered to the customer through the medical device FEops HEARTguide™ ALPACA (FEops - K223855) in the form of 3D model visualizations and a PDF report. All results are accessible through a standard web browser. The customer cannot modify the simulation results nor run additional simulations.
## 1.5 Intended Use
FEops HEARTguide™ Simulation Application is indicated for patient-specific simulation of transcatheter left atrial appendage occlusion (LAAO) device implantation during procedural planning.
The software performs computer simulation to predict implant frame deformation to support the evaluation for LAAO device size and placement.
FEops HEARTguide™ Simulation Application is intended to be used by qualified clinicians in conjunction with the simulated device instructions for use, the patient's clinical history, symptoms, and other preprocedural evaluations, as well as the clinician's professional judgment.
FEops HEARTguide™ Simulation Application is not intended to replace the simulated device instructions for use for final LAAO device selection and placement.
FEops HEARTguide™ Simulation Application is prescription use only.
## 1.6 Technological Characteristics
The subject device is compared to the previous cleared FEops HEARTguide™. The change on the subject device is the addition of the Boston Scientific Watchman FLX Pro device.
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FEops nv
Page 3 of 5
| | Predicate device | Subject Device | Comparison |
| --- | --- | --- | --- |
| Name | FEops HEARTguide™ | FEops HEARTguide™ / FEops HEARTguide™ Simulation Application | / |
| 510(k)/De Novo Number | K214066 | Subject Device | / |
| Manufacturer | FEops nv | FEops nv | Same |
| Regulation Number | 21 CFR 870.1405 | 21 CFR 870.1405 | Same |
| Device Classification Name | Interventional cardiovascular implant simulation software device | Interventional cardiovascular implant simulation software device | Same |
| Common name | FEops HEARTguide™ | FEops HEARTguide™ | Same |
| Product Code | QQI | QQI | Same |
| Product Class | II | II | Same |
| Review Advisory Panel | Cardiovascular | Cardiovascular | Same |
| Intended Use/Indications for Use | FEops HEARTguide is indicated for patient-specific simulation of transcatheter left atrial appendage occlusion (LAAO) device implantation during procedural planning. The software performs computer simulation to predict implant frame deformation to support the evaluation for LAAO device size and placement. FEops HEARTguide is intended to be used by qualified clinicians in conjunction with the simulated device instructions-for-use, the patient’s clinical history, symptoms, | FEops HEARTguide™ Simulation Application is indicated for patient-specific simulation of transcatheter left atrial appendage occlusion (LAAO) device implantation during procedural planning. The software performs computer simulation to predict implant frame deformation to support the evaluation for LAAO device size and placement. FEops HEARTguide™ Simulation Application is intended to be used by qualified clinicians in conjunction with the simulated device instructions for use, the patient’s clinical | Adding the Boston Scientific Watchman FLX Pro 40mm device |
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FEops nv
Page 4 of 5
| | and other
preprocedural
evaluations, as well as
the clinician's
professional
judgment.
FEops HEARTguide is
not intended to
replace the simulated
device's instructions
for use for final LAAO
device selection and
placement.
FEops HEARTguide is
prescription use only. | history, symptoms, and
other preprocedural
evaluations, as well as
the clinician's
professional judgment.
FEops HEARTguide™
Simulation Application
is not intended to
replace the simulated
device instructions for
use for final LAAO
device selection and
placement.
FEops HEARTguide™
Simulation Application
is prescription use
only. | |
| --- | --- | --- | --- |
| Prescription
Use only | Yes | Yes | Same |
| Software build | 1.4.2 | 4.0.0 | Releases in between
were documented
through LTF |
| Modelling
strategy | Device specific
computational model
applied to patient-
specific geometry | Device specific
computational model
applied to patient-
specific geometry | Same |
| Software
architecture | Simulation results
prepared by FEops
Case Analysts and
made available in Web
based Viewer | Simulation results
prepared by FEops
Case Analysts and
made available in Web
based Viewer | Same |
| Simulated
devices | 1. Boston Scientific
WATCHMAN
(P130013)
2. Boston Scientific
WATCHMAN FLX
(P130013/S035)
3. Abbott Amplatzer
Amulet (P200049) | 1. Boston Scientific
WATCHMAN
(P130013/S043)
2. Boston Scientific
WATCHMAN FLX
(P130013/S068)
3. Boston Scientific
WATCHMAN FLX Pro
(P130013/S068) | The subject device
includes 1 additional
LAAO device. The
WATCHMAN FLX and
FLX Pro have the
same device frame,
and the same
modelling strategy is
therefore used for
both device variants.
The subject device |
{8}
| | | 4. Abbott Amplatzer Amulet (P200049/S004) | includes a new device model for FLX Pro size 40 mm, which is not available for WATCHMAN FLX. |
| --- | --- | --- | --- |
The provided detailed comparison demonstrates the subject device is substantially equivalent in intended use, design, operating principles, materials and performance characteristics to the primary predicate device.
## 1.7 Performance Data
Clinical performance data was included in the 510(k)-submission demonstrating FEops HEARTguide™ Simulation Application has been validated for its intended use. The applied methods are similar to the methods applied for the design validation of the predicate device and similar performance has been demonstrated.
## 1.8 Summary
The characteristics that determine the functionality and performance of FEops HEARTguide™ Simulation Application, the subject device, are substantially equivalent to the predicate device cleared under 510(k) K214066. The testing indicates that the subject device is as safe, as effective, and performs as well as the predicate.
FEops nv
Page 5 of 5
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Learn the FDA Browser
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.
