MySOZO Software version 6.0.1.2 (SW version 6.0.1.2)
Applicant
ImpediMed Limited
Product Code
OBH · Cardiovascular
Decision Date
Jan 28, 2026
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 870.2770
Device Class
Class 2
Attributes
Software as a Medical Device
Indications for Use
The MySOZO Software version 6.0.1.2 is intended for adult patients living with heart failure. This device is intended for use, under the direction of a physician, for the noninvasive monitoring of patients with fluid management problems suffering from heart failure. Data from the device should be considered in conjunction with other clinical data. For adult human patients at risk of lymphedema: A bioimpedance spectroscopy device for use on adult human patients, utilizing impedance ratios that are displayed as an L-Dex ratio that supports the measurement of extracellular volume differences between the limbs and is presented to the clinician on an L-Dex scale as an aid to their clinical assessment of lymphedema. The use of the device to obtain an L-Dex score is only indicated for patients who will have or who have had lymph nodes, from the axillary and/or pelvic regions, either removed, damaged or irradiated. The MySOZO Software version 6.0.1.2 may be used as an adjunct to existing methods by aiding clinicians who are using Subjective Global Assessment (SGA) tools to assess patients at risk of protein-calorie malnutrition (PCM). The MySOZO Software version 6.0.1.2 may be further used to estimate the following body composition parameters in humans to track clinically relevant body composition parameters over time: • Fat mass • Fat-free mass • Total body water • Intracellular fluid • Extracellular fluid • Skeletal muscle mass The following outputs are also presented: • Body Mass Index (BMI) • Basal metabolic rate (BMR; based on Mifflin – St. Jeor’s algorithm) displayed in calories per day • Protein and mineral (also known as ‘dry lean mass’) represents the content of a body that is not fat or fluid; calculated by subtracting total body water weight from fat-free mass weight. The MySOZO Software version 6.0.1.2 device measures current (I), voltage (V) and phase angle (Phi), and from these values calculates resistance (R), reactance (Xc), and impedance (Z), which are used to estimate the above body composition parameters. The device/ software will also display the Cole plot, subject height, weight, age and sex.
Device Story
Bioimpedance spectroscopy system; measures body fluid/composition. Input: electrical current (200μA RMS) applied via stainless-steel electrodes at 256 frequencies (3kHz–1000kHz); measures voltage/phase angle. Transformation: calculates resistance, reactance, impedance, and L-Dex ratios; estimates body composition parameters (fat mass, fluid volumes, etc.) and BMR (Mifflin–St. Jeor algorithm). Output: L-Dex score, Cole plot, body composition metrics, BMI, BMR. Used in clinical settings; operated by clinicians. Data transmitted to cloud database; results accessed via web browser/tablet app. Assists clinicians in fluid management, lymphedema assessment, and malnutrition screening; provides longitudinal tracking of body composition to inform clinical decision-making.
Clinical Evidence
Bench testing only. Verification and validation testing confirmed software performance for UI updates, runtime application, Bluetooth connectivity, and the bilateral L-Dex assessment module.
Technological Characteristics
Bioimpedance spectroscopy; 256 frequencies (3kHz–1000kHz); 200μA RMS current. Stainless-steel electrodes. Cloud-based database; web browser interface; tablet-based (iOS/Android) control app. Bluetooth connectivity between tablet and hardware; Wi-Fi connectivity to cloud. Software-based calculation of impedance parameters and body composition.
Indications for Use
Indicated for adult patients with heart failure for noninvasive fluid management monitoring; adult patients at risk of lymphedema (post-axillary/pelvic lymph node removal, damage, or irradiation) for L-Dex ratio assessment; patients at risk of protein-calorie malnutrition as an adjunct to SGA tools; and individuals for tracking body composition parameters (fat mass, fat-free mass, total body water, intracellular/extracellular fluid, skeletal muscle mass, BMI, BMR, and dry lean mass).
Regulatory Classification
Identification
An impedance plethysmograph is a device used to estimate peripheral blood flow by measuring electrical impedance changes in a region of the body such as the arms and legs.
Special Controls
*Classification.* Class II (special controls). The device, when it is a body composition analyzer which is not intended to diagnose or treat any medical condition, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
{0}
FDA U.S. FOOD & DRUG ADMINISTRATION
January 28, 2026
Impedimed Limited
Richard Hines
Senior Manager of Regulatory Affairs
Unit 1
50 Parker Court Pinkenba
Pinkenba, QLD 4008
Australia
Re: K253224
Trade/Device Name: MySOZO Software version 6.0.1.2 (SW version 6.0.1.2)
Regulation Number: 21 CFR 870.2770
Regulation Name: Impedance Plethysmograph
Regulatory Class: Class II
Product Code: DSB, OBH, MNW
Dated: December 21, 2025
Received: December 29, 2025
Dear Richard Hines:
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
{1}
K253224 - Richard Hines
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).
{2}
K253224 - Richard Hines
Page 3
Sincerely,
MAURA ROONEY
-S
MAURA ROONEY
Maura Rooney
Assistant Director
DHT3A: Division of Renal, Gastrointestinal, Obesity, and Transplant Devices
OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
{3}
# 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. | K253224 | ? |
| --- | --- | --- |
| Please provide the device trade name(s). | | ? |
| MySOZO Software version 6.0.1.2 | | |
| Please provide your Indications for Use below. | | ? |
| MySOZO Software version 6.0.1.2 has the following uses:
The MySOZO Software version 6.0.1.2 is intended for adult patients living with heart failure.
This device is intended for use, under the direction of a physician, for the noninvasive monitoring of patients with fluid management problems suffering from heart failure. Data from the device should be considered in conjunction with other clinical data.
For adult human patients at risk of lymphedema:
A bioimpedance spectroscopy device for use on adult human patients, utilizing impedance ratios that are displayed as an L-Dex ratio that supports the measurement of extracellular volume differences between the limbs and is presented to the clinician on an L-Dex scale as an aid to their clinical assessment of lymphedema.
The use of the device to obtain an L-Dex score is only indicated for patients who will have or who have had lymph nodes, from the axillary and/or pelvic regions, either removed, damaged or irradiated.
The MySOZO Software version 6.0.1.2 may be used as an adjunct to existing methods by aiding clinicians who are using Subjective Global Assessment (SGA) tools to assess patients at risk of protein-calorie malnutrition (PCM).
The MySOZO Software version 6.0.1.2 may be further used to estimate the following body composition parameters in humans to track clinically relevant body composition parameters over time:
• Fat mass
• Fat-free mass
• Total body water
• Intracellular fluid
• Extracellular fluid
• Skeletal muscle mass
The following outputs are also presented:
• Body Mass Index (BMI)
• Basal metabolic rate (BMR; based on Mifflin – St. Jeor’s algorithm) displayed in calories per day
• Protein and mineral (also known as ‘dry lean mass’) represents the content of a body that is not fat or fluid; calculated by subtracting total body water weight from fat-free mass weight.
The MySOZO Software version 6.0.1.2 device measures current (I), voltage (V) and phase angle (Phi), and from these values calculates resistance (R), reactance (Xc), and impedance (Z), which are used to estimate the above body composition parameters. The device/ software will also display the Cole plot, subject height, weight, age and sex. | | |
| Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C) | |
{4}
impedimed
K253224
Page 1 of 3
# Traditional 510(k)
# SUMMARY
Impedimed MySOZO Software Version 6.0.1.2
## Submitter
Impedimed Limited
Unit 1
50 Parker Court
Pinkenba, Qld 4008
Australia
Phone: 760 585 2104
Facsimile: 760 804 9425
Contact Person: Richard Hines
Contact Email: rhines@impedimed.com
Date Prepared: September 23, 2025
Name of Device: MySOZO Software Version 6.0.1.2
Common or Usual Name: Body Fluid Analyzer
Regulation Number: 21 CFR §870.2770
Regulation Name: Impedance Plethysmograph
Regulatory Class: II
Product Code: DSB (Cardiac Electrophysiology, Diagnostics and Monitoring)
Predicate Device: SOZO Pro® (K232089)
Reference Device: SOZO(K180126)
## Purpose of the Traditional 510(k) Notice
The purpose of the 510(k) is to clear the MySOZO Software Version 6.0.1.2, which is the system software of the predicate K232089 SOZO Pro and the reference device, K180126 SOZO. MySOZO Software Version 6.0.1.2 includes verification and validation testing that incorporates updates to align the web browser and tablet application user interface (version 6.0), update to a runtime application and the hardening of the Bluetooth connectivity capabilities (version 6.0.1) and an update to the (version 6.0.1.2) bilateral L-Dex Assessment.
impedimed
510(k) Summary 1 of 3
{5}
impedimed
K253224
Page 2 of 3
# Indications for Use
MySOZO Software version 6.0.1.2 has the following uses:
The MySOZO Software version 6.0.1.2 is intended for adult patients living with heart failure.
This device is intended for use, under the direction of a physician, for the noninvasive monitoring of patients with fluid management problems suffering from heart failure. Data from the device should be considered in conjunction with other clinical data.
For adult human patients at risk of lymphedema:
A bioimpedance spectroscopy device for use on adult human patients, utilizing impedance ratios that are displayed as an L-Dex ratio that supports the measurement of extracellular volume differences between the limbs and is presented to the clinician on an L-Dex scale as an aid to their clinical assessment of lymphedema.
The use of the device to obtain an L-Dex score is only indicated for patients who will have or who have had lymph nodes, from the axillary and/or pelvic regions, either removed, damaged or irradiated.
The MySOZO Software version 6.0.1.2 may be used as an adjunct to existing methods by aiding clinicians who are using Subjective Global Assessment (SGA) tools to assess patients at risk of protein-calorie malnutrition (PCM).
The MySOZO Software version 6.0.1.2 may be further used to estimate the following body composition parameters in humans to track clinically relevant body composition parameters over time:
- Fat mass
- Fat-free mass
- Total body water
- Intracellular fluid
- Extracellular fluid
- Skeletal muscle mass
The following outputs are also presented:
- Body Mass Index (BMI)
- Basal metabolic rate (BMR; based on Mifflin – St. Jeor's algorithm) displayed in calories per day
- Protein and mineral (also known as 'dry lean mass') represents the content of a body that is not fat or fluid; calculated by subtracting total body water weight from fat-free mass weight.
The MySOZO Software version 6.0.1.2 device measures current (I), voltage (V) and phase angle (Phi), and from these values calculates resistance (R), reactance (Xc), and impedance (Z), which are used to estimate the above body composition parameters.
The device/software will also display the Cole plot, subject height, weight, age and sex.
# Device Description
MySOZO Software version 6.0.1.2 is the cloud-based software component of the overall ImpediMed SOZO Digital Health Platform device system. SOZO Digital health platform consists of several elements. MySOZO Software allows for bioimpedance measurements to be made with either the predicate (K232089) SOZO Pro or the reference (K180126) SOZO device.
Bioimpedance measurements are facilitated via the MySOZO Software with either the SOZO Pro or SOZO devices, which allows clinicians to evaluate patient fluid levels. Following the collection of the patient data (e.g., weight, height, dominant limb, age), the patient contacts the SOZO or SOZO Pro with their bare hands and feet on the stainless-steel electrodes. The MySOZO Software version 6.0.1.2 impedance measurement takes about 30 seconds, during which the SOZO or SOZO Pro®, applies small levels of electrical energy (200μA RMS) to the body across 256 frequencies spaced from 3kHz to 1000kHz and measures the resulting voltage levels. MySOZO Software transmits the impedance data to the database, calculates the values, and retrieves and displays the results upon request.
# Technological Characteristics
Bioimpedance spectroscopy software allows for data and is the technological principle by both the subject and predicate devices can measure patient fluid status. The subject and predicate devices are based on the following same fundamental technological elements:
impedimed
510(k) Summary 2 of 3
{6}
impedimed
K253224
Page 3 of 3
- MySOZO Software version 6.0.1.2 data is stored in and accessed from a cloud-based database (MySOZO) using a web browser interface. SOZO or SOZO Pro are controlled through an iOS or Android app ("SOZOapp") on a tablet computer, which is paired over a Bluetooth connection and connects with the MySOZO Software version 6.0.1.2 database over Wi-Fi.
- MySOZO Software version 6.0.1.2 is the software and database application that facilitates the SOZO Digital Health Platform devices (SOZO or SOZO Pro) to conduct bioimpedance measurements for patients at risk of the diseases identified in the indication for use statement.
# MySOZO Software Verification
## MySOZO Software Version 6.0
MySOZO Software Version 6.0, a software update to align the web browser and tablet application user interface and to ensure portability of patient information from one MySOZO software clinic to another. Verification and validation testing confirmed the performance of the software.
## MySOZO Software Version 6.0.1
MySOZO Software Version 6.0.1 was an update to the software to include the latest version of a runtime application and a reinforcement of Bluetooth technology software. Verification and validation confirmed the performance of the software.
## MySOZO Software Version 6.0.1.2
MySOZO Software Version 6.0.1.2 provides an update to the MySOZO L-Dex assessment module for patients at risk of bilateral lymphedema. Algorithm and software verification and validation confirmed the performance of the software.
## Substantial Equivalence
MySOZO Software Version 6.0.1.2 has the same intended use and indication for use statement, facilitates the same principles of operation, and technological characteristics as its predicate device. The differences in the MySOZO Software Version 6.0.1.2 design characteristics to the predicate SOZO Pro device do not raise any new questions of safety or effectiveness:
## Conclusions
Testing discussed above demonstrates that the MySOZO Software Version 6.0.1.2 device is safe and effective and performs as intended to assist in the intended performance and use of the predicate SOZO Pro (K232089) and reference SOZO (K180126) devices.
impedimed
510(k) Summary 3 of 3
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.
