Mac-Lab System: The Mac-Lab System is intended for monitoring, calculating and recording cardiovascular data from patients undergoing invasive cardiac catheterization procedures. The data may be manually entered or acquired via interfaced devices. ECG waveforms, heart rate, pulse oximetry (SpO2), respiration rate, EtCO2, temperature, valve gradients and areas, cardiac output, hemodynamic measurements, invasive blood pressure, procedural information, and optional intracardiac electrocardiogram (IECG). The information can be displayed, trended, stored, printed, and or transmitted to other networked hospital information systems. The system does not transmit alarms or arrhythmias and does not have arrhythmia detection capabilities. Interfaced devices the system may acquire, amplify, display and record anatomical and physiological data from includes equipment typically used in conjunction with these procedures, such as imaging and data devices (e.g. X-ray, ultrasound, magnetic resonance, computed tomography, positron emission tomography, nuclear medicine, 12 lead ECG and information systems.) CardioLab System: The CardioLab System is intended to acquire, filter, digitize, amplify, display and record the electrical signals. Signal types acquired include ECG signals, direct cardiac signals, temperature, EtCO2, and pressure recordings. Physiological parameters such as diastolic, systolic, and mean blood pressure, heart rate, and cycle length may be derived from the signal data, displayed and recorded. The system allows the user to monitor the acquisition of data, and generate reports on the data. Additionally, the system may acquire, amplify, display and record data received from other interfaced medical devices typically used during these procedures, such as imaging devices and ablation generators (i.e. RF and cryogenic). The CardioLab System does not control the delivery of energy, administer drugs, perform any life-sustaining functions, or analyze data acquired during the procedure. The CardioLab System does not transmit alarms or arrhythmias and does not have arrhythmia detection capabilities. Interfaced devices the system may acquire, amplify, display and record anatomical and physiological data from includes equipment typically used in conjunction with these procedures, such as imaging and data devices (e.g. X-ray, ultrasound, magnetic resonance, computed tomography, positron emission tomography, nuclear medicine, 12 lead ECG and information systems.) ComboLab System: The ComboLab System is the combination of the both the Mac-Lab and CardioLab systems. The ComboLab System is intended for use in either a catheterization laboratory or electrophysiological laboratory and related specialty laboratories under the direct supervision of a licensed healthcare practitioner. The user to run either the Mac-Lab System or the CardioLab System, although only one may be used at a time. SpecialsLab System: The SpecialsLab is the same as the Mac-Lab, CardioLab systems. The SpecialsLab System is intended for use in either a catheterization laboratory or electrophysiological laboratory and related specialty laboratories under the direct supervision of a licensed healthcare practitioner. SpecialsLab executes the same software, and runs on the same hardware. Products designated SpecialsLab will support fewer options than the Mac-Lab, CardioLab or ComboLab.
Device Story
System acquires, amplifies, filters, and digitizes physiological signals (ECG, IECG, pressure, temperature, EtCO2, SpO2) and procedural data during invasive cardiac catheterization or electrophysiological procedures. Inputs include manual entry and interfaced medical equipment (imaging, ablation generators). System displays, trends, stores, prints, and transmits data to hospital networks. Operated by clinicians in cath/EP labs. Does not perform arrhythmia detection, alarm transmission, energy delivery, or life-support functions. Provides hemodynamic calculations (valve gradients, cardiac output) and procedural reporting to assist clinical decision-making. Benefits include centralized data management and real-time visualization of patient status during complex cardiac interventions.
Clinical Evidence
No clinical data used. Substantial equivalence supported by bench testing, including risk analysis, design reviews, module verification, system integration, and final validation testing.
Technological Characteristics
Programmable diagnostic computer (21 CFR 870.1425). Hardware-based signal acquisition, filtering, amplification, and digitization. Connectivity via networked hospital information systems. Software-driven; same software/hardware architecture as predicate. No arrhythmia detection or alarm transmission capabilities.
Indications for Use
Indicated for patients undergoing invasive cardiac catheterization or electrophysiological procedures requiring monitoring, calculation, and recording of cardiovascular data. Used under direct supervision of licensed healthcare practitioners.
Regulatory Classification
Identification
A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.
{0}------------------------------------------------
GE Healthcare 510(k) K061741 Submission -- Reply to Reviewer Questions / Requests 08312006 .
| 5. | 510(k) Summary | SEP 15 2006 |
|----|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| | Date: | Amended September 6, 2006 |
| | Submitter: | GE Medical Systems Information Technologies<br>8200 West Tower Avenue<br>Milwaukee, WI 53223 USA |
| | Contact Person: | Allen D. Tabor<br>Quality & Regulatory Engineer<br>GE Medical Systems Information Technologies<br>Phone: (414) 721-3957<br>Fax: (414) 721-3862 |
| | Device Trade Name: | Mac-Lab/CardioLab/ComboLab/SpecialsLab System |
| | Common/Usual Name: | Cardiac Catheterization Laboratory System |
| | Classification Names: | 21 CFR 870.1425 Programmable Diagnostic Computer |
| | Predicate Device: | Mac-Lab/CardioLab EP/ComboLab System (K050093) |
K061741
:
page 1 of 3
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Page 12a (of a-d)
09/06/2006
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The product will be available in the following configurations: Mac-Lab application only, CardioLab application only, SpecialsLab only, or a combination of both CardioLab and Mac-Lab applications, marketed as Combol.ab. Products designated as SpecialsLab are identical to the Mac-Lab, Cardiol.ab or ComboLab Systems with the exception they will support fewer options. The SpecialsLab System performs the same intended use as the Mac-Lab, CardioLab or ComboLab, executes the same software, and runs on the same hardware. The product "CardioLab" was identified as "CardioLab EP" in the predicate device 510(k) submission K050093.
The Mac-Lab System: The Mac-Lab System is intended for monitoring, calculating and recording cardiovascular data from patients undergoing invasive cardiac catheterization procedures. The data may be manually entered or acquired via interfaced devices. Data includes: ECG waveforms, heart rate, pulse oximetry (SpO), respiration rate, EtCO2, temperature, valve gradients and areas, cardiac output, hemodynamic measurements, invasive and noninvasive blood pressure, procedural information, and optional intracardiac electrocardiogram (IECG). The information can be displayed, trended, stored, printed, and or transmitted to other networked hospital information systems. The system does not transmit alarms or arrhythmias and does not have arrhythmia detection capabilities.
Interfaced devices the system may acquire, amplify, display and record anatomical and physiological data from includes equipment typically used in conjunction with these procedures, such as imaging and data devices (e.g. X-ray, ultrasound, magnetic resonance, computed tomography, positron emission tomography, nuclear medicine. 12 lead ECG and information systems.)
The CardioLab System: The CardioLab System is intended to acquire. filter, digitize, amplify, display and record the electrical signal types acquired include ECG signals, direct cardiac signals. temperature, EtCO2, and pressure recordings. Physiological parameters such as diastolic, systolic, and mean blood pressure, heart rate, and cycle length mav be derived from the signal data, displayed and recorded. The system allows the user to monitor the acquisition of data, review the data, and generate reports on the data. Additionally, the system may acquire, amplify, display and record data received from other interfaced medical devices typically used during these procedures, such as imaging devices and ablation generators (i.e. RF and cryogenic).
ice Descript
The CardioLab System does not control the delivery of energy, administer drugs, perform any lifesupporting or life-sustaining functions. or analyze data acquired during the procedure. The CardioLab System does not transmit alarms or arrhythmias and does not have arrhythmia detection capabilities.
Interfaced devices the system may acquire, amplify, display and record anatomical and physiological data from includes equipment typically used in conjunction with these procedures. such as imaging and data devices (e.g. X-ray, ultrasound, magnetic resonance, computed tomography, positron emission tomography, nuclear medicine. 12 lead ECG and information systems.)
The ComboLab System: The ComboLab contiguration is the combination of both CardioLab and Mac-Lab applications, though only one application may be used at a time (CardioLab for electrophysiological lab cases and Mac-Lab for catheterization lab cases).
The SpecialsLab System: The SpecialsLab is the same as the Mac-Lab. CardioLab or ComboLab systems. The SpecialsLab System is intended for use in either a catheterization laboratory or electrophysiological laboratory and related specialty laboratories under the direct supervision of a ficensed healthcare practitioner. Specialst.ab executes the same software, and runs on the same hardware. Products designated SpecialsLab will support fewer options than the Mac-Lab. CardioLab or ComboLab.
041741 page 2 of B"
Page 12b (of a-d)
{2}------------------------------------------------
Mac-Lab System: The Mac-Lab System is intended for monitoring, calculating and recording cardiovascular data from patients undergoing invasive catheterization procedures. The data may be manually entered or acquired via interfaced devices. Data includes: ECG waveforms, heart rate, pulse oximetry (SpO2), respiration rate, EtCO2, temperature, valve gradients and areas, cardiac output, hemodynamic measurements, invasive and noninvasive blood pressure, procedural information, and optional intracardiac electrocardiogram (IECG). The information can be displayed, trended, stored, printed, and or transmitted to other networked hospital information systems. The system does not transmit alarms or arrhythmias and does not have arrhythmia detection capabilities.
Interfaced devices the system may acquire, amplify, display and record anatomical and physiological data from includes equipment typically used in conjunction with these procedures, such as imaging and data devices (e.g. X-ray, ultrasound, magnetic resonance, computed tomography, positron emission tomography, nuclear medicine, 12 lead ECG and information systems.)
CardioLab System: The CardioLab System is intended to acquire, filter, digitize, amplify, display and record the electrical signal types acquired include ECG signals, direct cardiac signals, temperature, EtCO2, and pressure recordings. Physiological parameters such as diastolic, systolic, and mean blood pressure, heart rate, and cycle length may be derived from the signal data, displayed and recorded. The system allows the user to monitor the acquisition of data, review the data, and generate reports on the data. Additionally, the system may acquire, amplify, display and record data received from other interfaced medical devices typically used during these procedures, such as imaging devices and ablation generators (i.e. RF and cryogenic).
The CardioLab System does not control the delivery of energy. administer drugs, perform any lifesupporting or life-sustaining functions, or analyze data acquired during the procedure. The CardioLab System does not transmit alarms or arrhythmias and does not have arrhythmia detection capabilities.
Interfaced devices the system may acquire, amplify, display and record anatomical and physiological data from includes equipment typically used in conjunction with these procedures. such as imaging and data devices (e.g. X-ray, ultrasound, magnetic resonance, computed tomography, positron emission tomography, nuclear medicine. 12 lead ECG and information systems.)
ComboLab System: The ComboLab System is the combination of the both the Mac-Lab and CardioLab systems. The ComboLab System is intended for use in either a catheterization laboratory or electrophysiological laboratory and related specialty laboratories under the direct supervision of a licensed healthcare practitioner. The ComboLab System allows the user to run either the Mac-Lab System or the CardioLab System, although only one may be used at a time.
SpecialsLab System: The SpecialsLab is the same as the Mac-Lab, CardioLab or ComboLab systems.. The SpecialsLab System is intended for use in either a catheterization laboratory or electrophysiological laboratory and related specialty laboratories under the direct supervision of a licensed healthcare practitioner. SpecialsLab executes the same software, and runs on the same hardware. Products designated SpecialsLab will support fewer options than the Mac-Lab. CardioLab or ComboLab.
ou 1741 page 3 of \$\frac{4}{8}\$
tended U
Page 12c (of a-d)
{3}------------------------------------------------
The proposed Mac-Lab/ComboLab/SpecialsLab System employs the same functional scientific technology as the predicate device Mac-Lab/CardioLab EP/ComboLab System (K050093).
The Mac-Lab/CardioLab/ComboLab/SpecialsLab System complies with the voluntary standards as detailed in Section 17.1 of this submission, "Specific Standards and Guidance's". The following quality assurance measures are applied to the device and the results thereof used in the determination of substantial equivalence to the predicate device:
- 0 Risk Analysis
- 0 Requirements Reviews
- est Summa o Design Reviews
- o Testing on unit level (Module verification)
- o Clinical Use Validation
- o Integration Testing (System verification)
- o Final acceptance testing (Validation)
- o Performance testing
- o Safety testing
- o Environmental Testing
No clinical performance data has been used to support the substantial equivalence claims
The results of these measurements demonstrate that the Mac-
I ab/CardioLab/ComboLab/SpecialsLab System is as safe, as effective, and performs as well as the predicate device.
Conclusion
echnolog
{4}------------------------------------------------
## DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle-like symbol with three overlapping wing-like shapes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
# SEP 1 5 2006
GE Medical Systems Information Technologies c/o Mr. Allen D. Tabor Quality & Regulatory Engineer GE Healthcare Interventional, Surgical & Cardiology 8200 West Tower Avenue Milwaukee, Wisconsin 55223
Re: K061741
Trade Name: Mac-Lab/CardioLab/ComboLab/SpecialsLab System Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II (two) Product Code: DQK Dated: September 6, 2006 Received: September 8, 2006
Dear Mr. Tabor:
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 (PMA), 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.
{5}------------------------------------------------
Page 2 - Mr. Allen D. Tabor
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 or any I cation beth 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 (21 CFR Part 820) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation of 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 premated 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 If you t the Office of Compliance at (240) 276-0120. 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/cdrh/industry/support/index.html.
Sincerely yours,
Bhimsimon for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{6}------------------------------------------------
#### 4 Indications for Use Statement
06174//
page 10 fl
#### Device Name: Mac-Lab/CardioLab/ComboLab/SpecialsLab System
### Mac-Lab System:
The Mac-Lab System is intended for monitoring, calculating and recording cardiovascular data from patients undergoing invasive cardiac catheterization procedures. The data may be manually entered or acquired via interfaced devices. ECG waveforms, heart rate, pulse oximetry (5p(2), respiration rate, EtCO2, temperature, valve gradients and areas, cardias output, hemodynamic measurements, invasive blood pressure, procedural information, and optional intracardiac electrocardiogram (IECG). The intornation can be displayed, trended, stored, printed, and or transmitted to other neworked hospital information systems. The system does not transmit alarns or arthythmias and does not have arthythmia detection capabilities.
Interfaced devices the system may acquire, amplify, display and record anatomical and physiological data from includes equipment typically used in conjunction with these procedures, such as maging and data devices (e.g. X-ray, ultrasound, magnetic resonance, computed tomography, position emission tomography, nuclear medicine, 12 lead ECG and information systems.)
#### CardioLab System:
The Cardiol.ab System is intended to acquire, filler, digitize, amplify, display and record the electrical signals. Signal types acquired include ECG signals, direct cardials, temperature, ElCO2, and pressure recordings. Physiological parancers such as diastolic, systolic, and mean blood pressure, hear rate, and cycle length may be derived from the signal data, displayed and recorded. The system allows the user to montor the acquisition of data, and generate reports on the data. Additionally, the system may acquire, amplify, display and received from other interfaced medical devices typically used during thesy processed to such as imaging devices and ablation generators (i.e. RF and cryogenic).
The Cardiol.ab System does not coutrol the delivery of energy, administer drugs, perform any fife-sustaining functions, or analyze data acquired during the procedure. The Cardiol.ab System does not transmit alarms or arthythmias and does not have arrhythmia detection capabilities.
Interfaced devices the system may acquire, amplify, display and record anatomical and physiological data from includes equipment typically used in coujunction with these procedures, such as imaging and data devices (e.g. X-ray, ultrasound, magnetic resonance, computed tomography, positron emission tomography, nuclear medicine, 12 lead ECG and information systems.)
#### ComboLab System:
The Combol.ab System is the combination of the both the Mac-Lab and CardioLab systems. The ComboLab System is intended for use in either a catheterization laboratory or electrophysiological laboratory and related specialty laboratories under the direct supervision of a ficensed healtheare practitioner. The User to run either the Mac-Lab System or the CardioLab System, although only one may be used at a time.
### SpecialsLab System:
The SpecialsLab is the same as the Mac-Lab. CardioLab systems. The SpecialsLab System is intended for use in cither a catheterization laboratory or electrophysiological laboratory and related specialty laboratories under the direct supervision of a licensed healtheare practitioner. SpecialsLab executes the same software, and runs on the same hardware. Products designated SpecialsLab will support fewer options than the Mac-Lab. Curdiol ab or ComboLab.
Prescription Use (Per 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (Per 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH. Office of Device Evaluation (ODE)
B. Hemmerana
vision Sign-Off
Division of Cardiovascular Devices
510(k) Number K041741
| |
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.
