K253151 · Beijing Fule Science & Technology Development Co., Ltd. · MAX · Jun 15, 2026 · Orthopedic
Device Facts
Record ID
K253151
Device Name
Fule Interbody Fusion Cage System
Applicant
Beijing Fule Science & Technology Development Co., Ltd.
Product Code
MAX · Orthopedic
Decision Date
Jun 15, 2026
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 888.3080
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
Cervical Device Cervical Spine (C2–T1): The FULE Interbody Fusion Cage Systems are indicated for use as intervertebral body fusion devices in skeletally mature patients with degenerative disc disease (DDD), defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies, at one level of the cervical spine with accompanying radicular symptoms. Patients should have undergone at least six weeks of non-operative treatment prior to surgery. The implants are intended to facilitate fusion in the cervical spine (C2–T1) and are placed via an anterior cervical approach, using autogenous bone graft. When used in the cervical spine, the FULE Interbody Fusion Cage Systems are not intended for stand-alone use and must be used with supplemental fixation systems that have been cleared by FDA for use in the cervical spine, such as anterior cervical plate and screw fixation systems. Lumbar Devices Lumbar Spine (L2–S1): The FULE Interbody Fusion Cage Systems are indicated for use as intervertebral body fusion devices in skeletally mature patients with degenerative disc disease (DDD), defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies, at one or two contiguous levels of the lumbar spine (L2–S1). Patients should have undergone at least six months of non-operative treatment prior to surgery. These implants are intended to facilitate fusion in the lumbar spine and are placed via an oblique lumbar interbody fusion (OLIF), posterior lumbar interbody fusion (PLIF), or transforaminal lumbar interbody fusion (TLIF) approach, using autograft or allograft bone graft. When used in the lumbar spine, the FULE Interbody Fusion Cage Systems are not intended for stand-alone use and must be used with supplemental fixation systems that have been cleared by FDA for use in the lumbar/lumbosacral spine, such as posterior pedicle screw and rod fixation systems.
Device Story
Hollow, implantable spinal fusion cages; manufactured from PEEK-OPTIMA (ASTM F2026) with optional tantalum markers (ASTM F560). Designed for cervical (ACIF/ACDF) and lumbar (PLIF, TLIF, OLIF) approaches. Implants feature central graft cavity for autograft/allograft bone; external serrations/ridges for migration resistance and stability. Used in surgical settings by surgeons; requires supplemental fixation (e.g., plates, screws, rods). Provides structural support to facilitate intervertebral body fusion; intended to alleviate discogenic back pain. Supplied sterile, single-use, radiation-sterilized.
Clinical Evidence
Bench testing only. Mechanical testing included static compression, shear, and torsion (ASTM F2077, F2267), and dynamic fatigue and subsidence testing. Biocompatibility testing (ISO 10993) confirmed cytotoxicity, sensitization, irritation, and systemic toxicity compliance. Sterilization and packaging validated per ISO 11137 and ISO 11607.
Technological Characteristics
Materials: PEEK-OPTIMA (ASTM F2026), tantalum markers (ASTM F560). Design: Hollow cage with central graft cavity and serrated/ridged surfaces. Energy: None. Connectivity: None. Sterilization: Radiation. Form factor: Multiple configurations for cervical/lumbar approaches.
Indications for Use
Indicated for skeletally mature patients with degenerative disc disease (DDD) at one cervical level (C2-T1) with radicular symptoms (after 6 weeks non-operative treatment) or one/two contiguous lumbar levels (L2-S1) (after 6 months non-operative treatment).
Regulatory Classification
Identification
An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.
Special Controls
*Classification.* (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
*Date premarket approval application (PMA) or notice of product development protocol (PDP) is required.* Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
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FDA U.S. FOOD & DRUG ADMINISTRATION
June 15, 2026
Beijing Fule Science & Technology Development Co., Ltd.
Xiaoliang Chen
International Sales Manager
No.50, Mafang West Industry Zone, Pinggu District
Beijing, 101204
China
Re: K253151
Trade/Device Name: Fule Interbody Fusion Cage System
Regulation Number: 21 CFR 888.3080
Regulation Name: Intervertebral Body Fusion Device
Regulatory Class: Class II
Product Code: MAX, ODP
Dated: May 15, 2026
Received: May 15, 2026
Dear Xiaoliang Chen:
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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K253151 - Xiaoliang Chen
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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 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-
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K253151 - Xiaoliang Chen
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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).
Sincerely,
**BRENT SHOWALTER -S**
Brent Showalter, Ph.D.
Assistant Director
DHT6B: Division of Spinal Devices
OHT6: Office of Orthopedic Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.
# Indications for Use
510(k) Number (if known)
K253151
Device Name
Fule Interbody Fusion Cage Systems
Indications for Use (Describe)
Cervical Device
Cervical Spine (C2–T1): The FULE Interbody Fusion Cage Systems are indicated for use as intervertebral body fusion devices in skeletally mature patients with degenerative disc disease (DDD), defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies, at one level of the cervical spine with accompanying radicular symptoms. Patients should have undergone at least six weeks of non-operative treatment prior to surgery.
The implants are intended to facilitate fusion in the cervical spine (C2–T1) and are placed via an anterior cervical approach, using autogenous bone graft. When used in the cervical spine, the FULE Interbody Fusion Cage Systems are not intended for stand-alone use and must be used with supplemental fixation systems that have been cleared by FDA for use in the cervical spine, such as anterior cervical plate and screw fixation systems.
Lumbar Devices
Lumbar Spine (L2–S1): The FULE Interbody Fusion Cage Systems are indicated for use as intervertebral body fusion devices in skeletally mature patients with degenerative disc disease (DDD), defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies, at one or two contiguous levels of the lumbar spine (L2–S1). Patients should have undergone at least six months of non-operative treatment prior to surgery.
These implants are intended to facilitate fusion in the lumbar spine and are placed via an oblique lumbar interbody fusion (OLIF), posterior lumbar interbody fusion (PLIF), or transforaminal lumbar interbody fusion (TLIF) approach, using autograft or allograft bone graft. When used in the lumbar spine, the FULE Interbody Fusion Cage Systems are not intended for stand-alone use and must be used with supplemental fixation systems that have been cleared by FDA for use in the lumbar/lumbosacral spine, such as posterior pedicle screw and rod fixation systems.
Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)
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# 510(k) Summary
This 510(k) Summary is submitted in accordance with the requirements of 21 CFR 807.92.
# 1. Submitter Information
- Submitter: Beijing Fule Science & Technology Development Co., Ltd.
- Address: No. 50, Mafang West Industry Zone, Pinggu District, Beijing, 101101, China
- Telephone: +86-10-60999861/2
- Fax: +86-10-60999863
- Contact Person: Xiaoliang Chen
- Date Prepared: 15 June 2026
# 2. Device Name
- Trade/Proprietary Name: Fule Interbody Fusion Cage Systems
- Common/Usual Name: Intervertebral body fusion device
- Classification Name: Intervertebral body fusion device (21 CFR 888.3080)
- Product Code: MAX (Lumbar), ODP (Cervical)
- Device Class: Class II
# 3. Predicate Devices
The subject device claims substantial equivalence to the primary predicate device identified below. Other legally marketed devices are identified as additional predicate devices to support approach-specific configurations and indications. These additional predicate devices are not used as split predicates;
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the substantial equivalence rationale is based on the same intended use as intervertebral body fusion devices and comparable technological characteristics.
| Role | 510(k) Number | Legally Marketed Device | Purpose in SE Rationale |
| --- | --- | --- | --- |
| Primary Predicate Device | K151726 | Posterior Lumbar Interbody Fusion Cage | Primary predicate to which substantial equivalence is claimed. This device was selected because it has the same general intended use as an intervertebral body fusion device and comparable technological characteristics, including PEEK body, radiographic markers, hollow graft cavity, surface features for migration resistance, and sterile single-use configuration. |
| Additional Predicate Device | K120486 | Anterior Cervical Interbody Fusion Cage | Additional predicate used to support the cervical ACIF/ACDF configuration and cervical approach-specific indications. |
| Additional Predicate Device | K100089 | T-PAL Posterior Lumbar Interbody Fusion Cage (TLIF) | Additional predicate used to support the TLIF/T-PAL posterior lumbar approach-specific configuration. |
| Additional Predicate Device | K172828 | OLIF Interbody Fusion Cage | Additional predicate used to support the OLIF lumbar approach-specific configuration. |
No separate reference device is relied upon in this 510(k) Summary for the determination of substantial equivalence.
#### 4. Device Description
The Fule Interbody Fusion Cage Systems are hollow, implantable spinal devices manufactured from Polyetheretherketone (PEEK-OPTIMA® LT1, ASTM F2026) with optional tantalum markers (ASTM F560) for radiographic visualization.
- The devices are available in multiple configurations to accommodate different surgical approaches:
- Anterior Cervical Interbody Fusion Cage (ACIF/ACDF)
- Posterior Lumbar Interbody Fusion Cage (PLIF)
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- ○ T-PAL Posterior Lumbar Interbody Fusion Cage (TLIF)
- ○ Oblique Lumbar Interbody Fusion Cage (OLIF)
- • Each implant contains a central graft cavity to permit packing with autograft or allograft bone.
- • The external surfaces incorporate serrations or ridges to resist migration and enhance initial stability.
- • The devices are supplied sterile, single-use only, sterilized by irradiation.
# 5. Indications for Use
- • **Lumbar Spine (L2–S1):**
The FULE Interbody Fusion Cage Systems are indicated for use as intervertebral body fusion devices in skeletally mature patients with degenerative disc disease (DDD), defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies, at one or two contiguous levels of the lumbar spine (L2–S1). Patients should have undergone at least six months of non-operative treatment prior to surgery.
- • These implants are intended to facilitate fusion in the lumbar spine and are placed via an oblique lumbar interbody fusion (OLIF), posterior lumbar interbody fusion (PLIF), or transforaminal lumbar interbody fusion (TLIF) approach, using autograft or allograft bone graft. When used in the lumbar spine, the FULE Interbody Fusion Cage Systems are not intended for stand-alone use and must be used with supplemental fixation systems that have been cleared by FDA for use in the lumbar/lumbosacral spine, such as posterior pedicle screw and rod fixation systems.
- • **Cervical Spine (C2–T1):**
The FULE Interbody Fusion Cage Systems are indicated for use as intervertebral body fusion devices in skeletally mature patients with degenerative disc disease (DDD), defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic
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studies, at one level of the cervical spine with accompanying radicular symptoms. Patients should have undergone at least six weeks of non-operative treatment prior to surgery.
- The implants are intended to facilitate fusion in the cervical spine (C2–T1) and are placed via an anterior cervical approach, using autogenous bone graft. When used in the cervical spine, the FULE Interbody Fusion Cage Systems are not intended for stand-alone use and must be used with supplemental fixation systems that have been cleared by FDA for use in the cervical spine, such as anterior cervical plate and screw fixation systems.
## 6. Technological Characteristics
The subject devices have the same technological characteristics as the predicates, including:
- Same fundamental design (hollow body, bone graft cavity, serrated/ridged surface).
- Same materials (PEEK, tantalum).
- Same principle of operation (structural support and promotion of spinal fusion).
- Supplied sterile, single-use only.
Differences are limited to cage dimensions and approach-specific designs, which do not raise new questions of safety or effectiveness.
## 7. Performance Data
Nonclinical testing was performed in accordance with FDA-recognized consensus standards and applicable guidance:
- Mechanical Testing (ASTM F2077, ASTM F2267):
- Static compression, static shear, static torsion
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- ○ Dynamic fatigue (compression and torsion)
- ○ Subsidence testing
- • Biocompatibility (ISO 10993 series):
- ○ Cytotoxicity, sensitization, irritation, systemic toxicity
- • Sterilization & Packaging Validation:
- ○ Radiation sterilization validated per ISO 11137
- ○ Packaging validated per ISO 11607 and ASTM F88, F1929, F2096, F1886
Results demonstrate that the subject devices perform comparably to the predicate devices and meet all acceptance criteria.
## 8. Conclusion
The Fule Interbody Fusion Cage Systems are substantially equivalent to the identified predicate devices (K120486, K151726, K100089, K172828). The subject devices have the same intended use, indications, materials, and technological characteristics as the predicates. Performance testing confirmed that any differences do not raise new questions of safety or effectiveness.
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.