K262839 · Cleerly, Inc. · QXZ · Oct 29, 2026 · Cardiovascular
Device Facts
Record ID
K262839
Device Name
Cleerly ISCHEMIA
Applicant
Cleerly, Inc.
Product Code
QXZ · Cardiovascular
Decision Date
Oct 29, 2026
Decision
SESE
Submission Type
Special
Regulation
21 CFR 870.2200
Device Class
Class 2
Attributes
AI/ML, Software as a Medical Device
AI Performance
Output
Algorithm
Acceptance
Observed
Dev DS
Dev Readers
Test DS
Test Readers
Coronary vessel ischemia
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Clinical study results from K231335
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Indications for Use
Cleerly ISCHEMIA analysis software is an automated machine learning-based decision support tool, indicated as a diagnostic aid for patients undergoing CT analysis using Cleerly LABS software. When utilized by an interpreting healthcare provider, this software tool provides information that may be useful in detecting likely ischemia associated with coronary artery disease. Patient management decisions should not be made solely on the results of the Cleerly ISCHEMIA analysis.
Device Story
Cleerly ISCHEMIA is an add-on software module for Cleerly LABS; it processes quantitative measures of atherosclerosis, stenosis, and vascular morphology derived from CCTA images. The device uses a machine learning-based algorithm to determine the presence or absence of coronary vessel ischemia. It outputs a binary Cleerly ISCHEMIA Index (CII), where positive/negative results correspond to invasive FFR thresholds of >0.80 vs. ≤0.80. The software is accessed by healthcare providers via a client-server Google Chrome application. It serves as a diagnostic aid; results are intended to be used in conjunction with other clinical data to inform patient management decisions, potentially benefiting patients by providing non-invasive ischemic status information.
Clinical Evidence
Clinical performance was established via the predicate device (K231335), which was validated on a US/OUS cohort across 23 independent clinical sites. No new clinical studies were required for this submission as the modifications did not impact safety or effectiveness. Bench testing and software verification/validation (per IEC 62304) confirmed that the updated software meets all predefined acceptance criteria.
Technological Characteristics
SaMD; machine learning-based algorithm; client-server architecture accessed via Google Chrome. Operates on quantitative CCTA image data. Risk management per ISO 14971:2019; software lifecycle per IEC 62304. Cybersecurity controls implemented per FDA guidance.
Indications for Use
Indicated for adult patients (22+ years) undergoing coronary CT angiography (CCTA) analysis to assist healthcare providers in detecting likely ischemia associated with coronary artery disease.
Regulatory Classification
Identification
The adjunctive cardiovascular status indicator is a prescription device based on sensor technology for the measurement of a physical parameter(s). This device is intended for adjunctive use with other physical vital sign parameters and patient information and is not intended to independently direct therapy.
Special Controls
*Classification.* Class II (special controls). The special controls for this device are:(1) Software description, verification, and validation based on comprehensive hazard analysis must be provided, including:
(i) Full characterization of technical parameters of the software, including any proprietary algorithm(s);
(ii) Description of the expected impact of all applicable sensor acquisition hardware characteristics on performance and any associated hardware specifications;
(iii) Specification of acceptable incoming sensor data quality control measures; and
(iv) Mitigation of impact of user error or failure of any subsystem components (signal detection and analysis, data display, and storage) on accuracy of patient reports.
(2) Scientific justification for the validity of the status indicator algorithm(s) must be provided. Verification of algorithm calculations and validation testing of the algorithm using a data set separate from the training data must demonstrate the validity of modeling.
(3) Usability assessment must be provided to demonstrate that risk of misinterpretation of the status indicator is appropriately mitigated.
(4) Clinical data must be provided in support of the intended use and include the following:
(i) Output measure(s) must be compared to an acceptable reference method to demonstrate that the output measure(s) represent(s) the predictive measure(s) that the device provides in an accurate and reproducible manner;
(ii) The data set must be representative of the intended use population for the device. Any selection criteria or limitations of the samples must be fully described and justified;
(iii) Agreement of the measure(s) with the reference measure(s) must be assessed across the full measurement range; and
(iv) Data must be provided within the clinical validation study or using equivalent datasets to demonstrate the consistency of the output and be representative of the range of data sources and data quality likely to be encountered in the intended use population and relevant use conditions in the intended use environment.
(5) Labeling must include the following:
(i) The type of sensor data used, including specification of compatible sensors for data acquisition;
(ii) A description of what the device measures and outputs to the user;
(iii) Warnings identifying sensor reading acquisition factors that may impact measurement results;
(iv) Guidance for interpretation of the measurements, including warning(s) specifying adjunctive use of the measurements;
(v) Key assumptions made in the calculation and determination of measurements;
(vi) The measurement performance of the device for all presented parameters, with appropriate confidence intervals, and the supporting evidence for this performance; and
(vii) A detailed description of the patients studied in the clinical validation (
*e.g.,* age, gender, race/ethnicity, clinical stability) as well as procedural details of the clinical study.
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**FDA** U.S. FOOD & DRUG
ADMINISTRATION
October 29, 2026
Cleerly, Inc.
Ivan Pulido
Senior Regulatory Affairs Specialist
1099 18th St., Suite 2860
Denver, Colorado 80202
Re: K262839
Trade/Device Name: Cleerly ISCHEMIA
Regulation Number: 21 CFR 870.2200
Regulation Name: Adjunctive Cardiovascular Status Indicator
Regulatory Class: Class II
Product Code: QXZ
Dated: September 29, 2026
Received: September 30, 2026
Dear Ivan Pulido:
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.
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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K262839 - Ivan Pulido
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Before making any change significantly affecting the safety or effectiveness of the device, you must submit a new premarket notification in accordance with 21 CFR 807.81. 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" (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 Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).
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 Management System Regulation (QMSR) (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
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K262839 - Ivan Pulido
Page 3
Office of Industry and Consumer Education (OICE) to ask a question about a specific regulatory topic. See the OICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-office-industry-and-consumer-education-oice) for more information or contact OICE by email (AskOICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
STEPHEN C. BROWNING -S
CDR Stephen Browning
Assistant Director
Division of Cardiac Electrophysiology,
Diagnostics, and Monitoring Devices
Office of Cardiovascular Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
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| Indications for Use | | |
| --- | --- | --- |
| Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K262839 | ? |
| Please provide the device trade name(s). | | ? |
| Cleerly ISCHEMIA | | |
| Please provide your Indications for Use below. | | ? |
| Cleerly ISCHEMIA analysis software is an automated machine learning-based decision support tool, indicated as a diagnostic aid for patients undergoing CT analysis using Cleerly LABS software. When utilized by an interpreting healthcare provider, this software tool provides information that may be useful in detecting likely ischemia associated with coronary artery disease. Patient management decisions should not be made solely on the results of the Cleerly ISCHEMIA analysis. | | |
| Please select the types of uses. | ☑ Prescription Use (21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ? |
| Please select the age group(s) for which the device(s) is to be used. | ☐ Neonates/Newborns (Birth to < 29 days old) ☐ Infants (29 days old to < 2 years old) ☐ Children (2 years old to < 12 years old) ☐ Adolescents (12 years old to < 22 years old) ☑ Adults (22 years old and greater) | ? |
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## 510(k) Summary
This 510(k) Summary is provided per the requirements of section 21 CFR 807.92 on 08/10/2026.
### 1. Submitter
| Submitter | Cleerly, Inc. |
| --- | --- |
| Contact Person | Ivan Pulido Senior Regulatory Affairs Specialist |
| Address | 1099 18^{th} St Suite 2860 Denver CO 80202 |
| Phone | (512) 630-1709 |
| Email | Ivan.pulido@cleerlyhealth.com |
### 2. Device Information
| Trade Name | Cleerly ISCHEMIA |
| --- | --- |
| Common Name | Adjunctive Epicardial Vascular Physiologic Status Indicator |
| Classification Name | Adjunctive cardiovascular status indicator |
| Product Classification | Class II, § 870.2200 |
| Product Code | QXZ |
### 3. Predicate Device
| Trade Name | Cleerly ISCHEMIA |
| --- | --- |
| Common Name | Adjunctive Epicardial Vascular Physiologic Status Indicator |
| Classification Name | Adjunctive cardiovascular status indicator |
Cleerly Inc.
1099 18th St, Suite 2860
Denver, CO 80202
K262839
Page 1 of 5
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| Product Classification | Class II, § 870.2200 |
| --- | --- |
| Product Code | QXZ |
#### 4. Device Description
Cleerly ISCHEMIA is an add-on software module to Cleerly LABS (K260588) that determines the likely presence or absence of coronal vessel ischemia based on quantitative measures of atherosclerosis, stenosis, and significant vascular morphology from typically-acquired Coronary Computed Tomography Angiography images (CCTA). Cleerly ISCHEMIA, in conjunction with Cleerly LABS, outputs a Cleerly ISCHEMIA Index (CII), a binary indication of negative CII (likely absence of ischemia) or positive CII (likely presence of ischemia) with its threshold equivalent to invasive FFR >0.80 vs. ≤0.80, respectively, as identified in professional societal practice guidelines.
#### 5. Indications for Use
Cleerly ISCHEMIA analysis software is an automated machine learning-based decision support tool, indicated as a diagnostic aid for patients undergoing CT analysis using Cleerly Labs software. When utilized by an interpreting healthcare provider, this software tool provides information that may be useful in detecting likely ischemia associated with coronary artery disease. Patient management decisions should not be made solely on the results of the Cleerly ISCHEMIA analysis.
#### 6. Substantial Equivalence
The subject version of Cleerly ISCHEMIA has an identical intended use, the same analytical methodology, clinical functionality, operating principles, and fundamental technological characteristics as the previously cleared predicate Cleerly ISCHEMIA (K231335) device. This submission supports implementation of Cleerly ISCHEMIA with the modular software architecture described in Cleerly LABS (K260588). This submission also incorporates minor post-market software improvements and software maintenance updates necessary to support the current software environment. Software testing demonstrates that the subject device Cleerly ISCHEMIA continues to be safe and effective for its intended use and substantially equivalent to the predicate device.
Cleerly Inc.
1099 18th St, Suite 2860
Denver, CO 80202
K262839
Page 2 of 5
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cleerly
The following table compares the key features of the subject and predicate device.
| Characteristic | Subject Device Cleerly ISCHEMIA, K262839 | Predicate Device Cleerly ISCHEMIA, K231335 |
| --- | --- | --- |
| Regulation | 21 CFR 870.2200 | -same- |
| Generic Device Type | Adjunctive cardiovascular status indicator | -same- |
| SaMD | Yes | -same- |
| Intended Use | Providing adjunctive information a patient's cardiovascular condition (diagnostic aid for ischemia associated with coronary artery disease) | -same- |
| Indications for Use | Cleerly ISCHEMIA analysis software is an automated machine learning-based decision support tool, indicated as a diagnostic aid for patients undergoing CT analysis using Cleerly LABSsoftware. When utilized by an interpreting healthcare provider, this software tool provides information that may be useful in detecting likely ischemia associated with coronary artery disease. Patient management decisions should not be made solely on the results of the Cleerly ISCHEMIA analysis. | -same- |
| Anatomical Site | Cardiovascular | -same- |
| Users | Healthcare provider | -same- |
| Machine Learning-Based Algorithm | Yes | -same- |
| Operating Platform | Platform accessed via Client-Server Google Chrome Application | -same- |
| Risk Management | In accordance with ISO 14971:2019 | -same- |
| Cybersecurity | Content of Premarket Submissions for Management of Cybersecurity in Medical Devices. | -same- |
| Usability | Usability assessment determined there were no critical tasks | -same- |
Cleerly Inc.
1099 18th St, Suite 2860
Denver, CO 80202
K262839
Page 3 of 5
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cleerly
| Characteristic | Subject Device Cleerly ISCHEMIA | Predicate Device Cleerly ISCHEMIA, K231335 |
| --- | --- | --- |
| | associated with the use of the device. | |
| Pre-clinical Performance Testing | No animal studies were conducted. | -same- |
| Bench Performance Testing | Technical validation. | -same- |
| Clinical Performing Testing | Validated on a US/OUS cohort population, comprising 23 independent clinical sites representative of the intended use population. | -same- |
| Regulation | 21 CFR 870.2200 | -same- |
| Generic Device Type | Adjunctive cardiovascular status indicator | -same- |
| SaMD | Yes | -same- |
### 7. Performance Data
Cleerly ISCHEMIA has been designed, verified and validated as described in ISO 13485, Clause 7.3 and its subclauses. The following non-clinical performance data were provided in support of substantial equivalence. The outputs of these design control and software evaluation activities demonstrate that the modified device remains safe and effective for its intended use. It is substantially equivalent to, and serves the identical clinical application as, the originally cleared device (K231335).
### 7.1. Risk Management
Assessment performed according to ISO 14971, Medical Devices – Application of Risk Management to Medical Devices. All hazards and failures for the subject device have the same severity and occurrence as the predicate. No new or unresolved unknown hazards, hazardous situations and harm were identified.
### 7.2. Software Testing
Software evaluation activities adhered to IEC 62304, Medical Device Software - Software Life Cycle Processes. Testing was conducted across multiple pre-production environments using simulated data, as well as in production for final release verification. These activities confirmed that all software requirements met their predefined acceptance criteria. Subsequent regression testing verified that technological updates did not compromise the device's overall performance or functionality.
Cleerly Inc.
1099 18th St, Suite 2860
Denver, CO 80202
K262839
Page 4 of 5
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### 8. Clinical Data
Clinical performance of the subject device was evaluated to confirm that the modifications did not impact its safety or effectiveness relative to the predicate device. The clinical study results from K231335 remain fully applicable to the subject device; therefore, no additional clinical studies were required to support substantial equivalence. The modifications introduced no clinically significant differences that would affect the device's safety or effectiveness..
### 9. Conclusions
The subject version of Cleerly ISCHEMIA has the same intended use, analytical methodology, clinical functionality, operating principles, and fundamental technological characteristics as the predicate Cleerly ISCHEMIA (K231335). The modifications to support implementation with the Cleerly LABS modular software architecture, together with minor software improvements and maintenance updates, do not raise different questions of safety or effectiveness, and no changes have been made to the Cleerly ISCHEMIA machine learning algorithms. Performance testing demonstrates that the subject device continues to perform as intended and is as safe and effective for its intended use as the predicate device. Thus, the results of performance testing support that the subject device is substantially equivalent to the predicate device for its intended use.
Cleerly Inc.
1099 18th St, Suite 2860
Denver, CO 80202
K262839
Page 5 of 5
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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.
Use the checkboxes above the results to narrow: SaMD keeps only Software as a Medical Device, 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 as a Medical Device), 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.
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.
