K253045 · Socko Medical Co., Ltd. · NKB · Jun 17, 2026 · Orthopedic
Device Facts
Record ID
K253045
Device Name
“Socko” Vimax Spinal Fixation System
Applicant
Socko Medical Co., Ltd.
Product Code
NKB · Orthopedic
Decision Date
Jun 17, 2026
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 888.3070
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The “Socko” Vimax Spinal Fixation System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine. The “Socko” Vimax Spinal Fixation System can be used in a percutaneous approach. The “Socko” Vimax Spinal Fixation System is intended for noncervical pedicle fixation from T1 to S1 for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; deformities (i.e., scoliosis, kyphosis, and/or lordosis); spinal tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.
Device Story
Spinal fixation system; provides immobilization/stabilization of thoracic, lumbar, and sacral spine segments; adjunct to fusion. Components: titanium alloy (Ti6Al4V) pedicle screws (fenestrated/reduction) and rods. Implanted via posterior approach; percutaneous or open. Used by surgeons in clinical/OR settings. Mechanical stabilization of spinal segments; supports fusion process; treats instabilities/deformities. Benefits: patient stabilization; correction of spinal alignment.
Clinical Evidence
No clinical data provided. Substantial equivalence supported by bench testing per ASTM F1717-21, including static axial compression, static torsion, and dynamic axial compression testing.
Technological Characteristics
Material: Titanium alloy Ti6Al4V (ISO 5832-3, ASTM F136). Components: Fenestrated cortical screws (4.5-7.0mm diameter, 25-60mm length), rods (5.5mm diameter, 40-550mm length). Mechanical fixation via pedicle screws. Sterilization: End-user sterilized. No software or electronic components.
Indications for Use
Indicated for skeletally mature patients requiring immobilization/stabilization of thoracic, lumbar, and sacral spine segments as an adjunct to fusion. Conditions include degenerative disc disease, spondylolisthesis, trauma (fracture/dislocation), spinal stenosis, deformities (scoliosis, kyphosis, lordosis), spinal tumor, pseudoarthrosis, and failed previous fusion. Used for noncervical pedicle fixation (T1-S1) via percutaneous or open approach.
Regulatory Classification
Identification
(1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
Special Controls
*Classification.* (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.
Predicate Devices
Mont Blanc and Mont Blanc MIS Spinal Systems (K161387)
Submission Summary (Full Text)
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**FDA** **U.S. FOOD & DRUG**
ADMINISTRATION
June 17, 2026
Socko Medical Co., Ltd.
Ariel Huang
RA
10F-3, No. 8, Ln. 609, Sec. 5, Chongxin Rd., Sanchong Dist
New Taipei, 24159
Taiwan
Re: K253045
Trade/Device Name: 'Socko' Vimax Spinal Fixation System
Regulation Number: 21 CFR 888.3070
Regulation Name: Thoracolumbosacral Pedicle Screw System
Regulatory Class: Class II
Product Code: NKB
Dated: May 18, 2026
Received: May 19, 2026
Dear Ariel Huang:
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 20903
www.fda.gov
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K253045 - Ariel Huang
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 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-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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K253045 - Ariel Huang
Page 3
Sincerely,
**EILEEN
CADEL-S** for
Colin O'Neill, M.B.E.
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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# 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. | K253045 | ? |
| --- | --- | --- |
| Please provide the device trade name(s). | | ? |
| “Socko” Vimax Spinal Fixation System | | |
| Please provide your Indications for Use below. | | ? |
| The “Socko” Vimax Spinal Fixation System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine. The “Socko” Vimax Spinal Fixation System can be used in a percutaneous approach. The “Socko” Vimax Spinal Fixation System is intended for noncervical pedicle fixation from T1 to S1 for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; deformities (i.e., scoliosis, kyphosis, and/or lordosis); spinal tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients. | | |
| Please select the types of uses (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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K253045
Page 1 of 5
Socko Medical Co., Ltd.
“Socko” Vimax Spinal Fixation System
Traditional 510(k)
510(k) Summary
## K253045 - 510(k) Summary
1. **Type of submission:** Traditional
2. **Date of summary:** June 17, 2026
### 3. Submitter information:
| **Name:** | Socko Medical Co., Ltd. |
| --- | --- |
| **Address:** | 10F-3, No. 8, Ln. 609, Sec. 5, Chongxin Rd., Sanchong Dist., New Taipei City 24159, Taiwan |
| **Phone:** | +886-2-2999-1288 |
| **Fax:** | +886-2-2999-1287 |
| **Correspondent:** | Ariel Huang (shingmissbig@gmail.com) |
### 4. Identification of the subject device:
Device Name: “Socko” Vimax Spinal Fixation System
Review Panel: Orthopedic
Regulation Number: 21 CFR 888.3070
Regulation Description: Thoracolumbosacral pedicle screw system
Classification Product Code: NKB
Device Class: Class II
### 5. Identification of the primary predicate device:
**510(k) number:** K161387
Device Name: Mont Blanc and Mont Blanc MIS Spinal Systems
**Manufacturer:** Spineway S.A.
Review Panel: Orthopedic
Regulation Number: 21 CFR 888.3070
Regulation Description: Thoracolumbosacral pedicle screw system
Classification Product Code: NKB
Subsequent Product Code: OSH, MNI, MNH, KWP
Device Class: Class II
### 6. Description
The “Socko” Vimax Spinal Fixation System is composed of implant devices made from a titanium alloy Ti6Al4V per ISO 5832-3 and ASTM F136. It is to be implanted from the posterior approach. The screws are available as Vimax MIS Fenestrated Cortical Screw (in diameters from 4.5-7.0 mm and in lengths from 25-60 mm), Vimax MIS Reduction Fenestrated Cortical Screw and Vimax LT Fenestrated Cortical Screw in
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K253045
Page 2 of 5
Socko Medical Co., Ltd.
“Socko” Vimax Spinal Fixation System
Traditional 510(k)
510(k) Summary
diameters from 5.0-7.0 mm and in lengths from 30-60 mm and Screw Nut of 8.7 mm diameters with height of 4.2 mm. The rods are available as Traction Pre-bend Rod in 5.5mm diameter and in lengths from 40-140 mm and Traction Rod in 5.5mm diameter and in lengths from 100-550 mm.
### 7. Indications for Use
The “Socko” Vimax Spinal Fixation System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.
The “Socko” Vimax Spinal Fixation System can be used in a percutaneous approach. The “Socko” Vimax Spinal Fixation System is intended for noncervical pedicle fixation from T1 to S1 for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; deformities (i.e., scoliosis, kyphosis, and/or lordosis); spinal tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.
### 8. Performance Data - Non-clinical Testing
We provided following non-clinical testing in accordance with the ASTM F1717-21 standard in support of the substantial equivalence determination.
- Static axial compression testing
- Static torsion testing
- Dynamic axial compression testing
We performed “Static axial compression testing” and “Static torsion testing” to verify that the compressive yield load and torsional yield torque of the construct exceed the mechanical performances of the predicate device. We performed “Dynamic axial compression testing” to verify that the construct does not experience any failure at a higher endurance load limit.
All the test results demonstrate “Socko” Vimax Spinal Fixation System is substantially equivalent to the predicate device.
### 9. Performance Data - Clinical Testing
No clinical test data was used to support the decision of substantial equivalence.
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K253045
Page 3 of 5
Socko Medical Co., Ltd.
"Socko" Vimax Spinal Fixation System
Traditional 510(k)
510(k) Summary
### 10. Substantial equivalence comparison
"Socko" Vimax Spinal Fixation System submitted in 510(k) files is substantially equivalent in intended use, safety and performance to the FDA cleared Mont Blanc and Mont Blanc MIS Spinal Systems (K161387). Differences between the devices cited in this section do not raise any new issue of substantial equivalence.
| Item | Subject device | Predicate device | Equivalent |
| --- | --- | --- | --- |
| Proprietary name | "Socko" Vimax Spinal Fixation System | Mont Blanc and Mont Blanc MIS Spinal Systems | - |
| 510(k) no. | K253045 | K161387 | - |
| Indications for Use | The "Socko" Vimax Spinal Fixation System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine. The "Socko" Vimax Spinal Fixation System can be used in a percutaneous approach. The "Socko" Vimax Spinal Fixation System is intended for noncervical pedicle fixation from T1 to S1 for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic | The Mont Blanc and Mont Blanc MIS Spinal Systems are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine and sacral/iliac screw fixation. The Mont Blanc and Mont Blanc MIS Spinal Systems are intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal | *Equivalent* |
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K253045
Page 4 of 5
Socko Medical Co., Ltd.
"Socko" Vimax Spinal Fixation System
Traditional 510(k)
510(k) Summary
| Item | Subject device | Predicate device | Equivalent |
| --- | --- | --- | --- |
| | studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; deformities (i.e., scoliosis, kyphosis, and/or lordosis); spinal tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients. | stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients. | |
| Type of Use | Prescription Use | Prescription Use | *Same* |
| Level of Use | T1-S1 | T1-S1 | *Same* |
| Conditions for Use | Professional use only in a professional healthcare environment. | Professional use only in a professional healthcare environment. | *Same* |
| Intended user | Skeletally mature patients | Skeletally mature patients and pediatric patients | *Different.* The intended user of the subject device is narrower |
| Material | Titanium alloy Ti6Al4V | Titanium alloy Ti6Al4V-ELI and Cobalt-Chrome | *Equivalent.* Both the devices have the material Ti6Al4V |
| Sterilization | End user sterilized | Provided sterile | *Different* |
| Screws | Diameters: 4.5-7.0 mm Length: 25-60 mm | Diameters: 4.0-8.0 mm Length: 25-110 mm | *Equivalent.* The size range of subject device is equivalent with predicate device. |
| Rods | Diameters: 5.5 mm Length: 40-550 mm | Diameters: 5.5 mm Length: 40-500 mm | *Equivalent.* The size range of subject device is equivalent with predicate device. The |
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K253045
Page 5 of 5
Socko Medical Co., Ltd.
"Socko" Vimax Spinal Fixation System
Traditional 510(k)
510(k) Summary
| Item | Subject device | Predicate device | Equivalent |
| --- | --- | --- | --- |
| | | | safety and performance test has been completed to demonstrate safety and effectiveness. |
### 11. Conclusion
The data demonstrates that the subject device is substantially equivalent to the predicate device.
5 / 5
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.
