The intended use of the MECTA spECTrum ECT device is solely for the treatment of "severe depression" or "major depressive episode with melancholia". (ref 21 CFR Part 882 Part III) The clinical setting is in hospital ECT suites, Operating Rooms, or on patient wards.
Device Story
The MECTA spECTrum 5000/4000 series are electroconvulsive therapy (ECT) devices used in hospital suites, ORs, or wards by clinicians. They deliver constant-current, bi-directional square waveform electrical stimuli to induce therapeutic seizures. The 5000 series monitors up to six channels of ECG/EEG and includes an Optical Motion Sensor (OMS); the 4000 series functions as the ECT module. Inputs include user-defined stimulus parameters (frequency, duration, intensity) via touchscreen. The device performs continuous self-tests and monitors physiological signals during treatment. Outputs include stimulus delivery, real-time EEG/ECG/OMS data on an LCD, and hard-copy thermal chart recordings of self-test and treatment results. Safety features include a hinged stimulus button cover, status LEDs, and warning tones. Clinicians use the monitored data to assess seizure adequacy and efficacy, allowing for individualized treatment adjustments. The device aims to improve patient safety and treatment efficacy through advanced monitoring and redundant hardware/software verification.
Clinical Evidence
No clinical data provided. The submission relies on bench testing, design verification, and compliance with international safety standards (IEC 601-1, IEC 601-2-14, UL 544, CSA 22.2 125) to demonstrate safety and performance.
Technological Characteristics
Constant-current bi-directional square waveform generator. Features include LCD touchscreen interface, thermal chart recorder, ECG/EEG monitoring channels, and Optical Motion Sensor. Designed to meet UL 544, CSA 22.2 125, and IEC 601-1/601-2-14 standards. Includes redundant hardware and software for self-testing and stimulus delivery control. Connectivity includes thermal printer output and lead-based physiological monitoring.
Indications for Use
Indicated for treatment of severe depression or major depressive episode with melancholia in patients requiring electroconvulsive therapy.
Regulatory Classification
Identification
An electroconvulsive therapy device is a prescription device, including the pulse generator and its stimulation electrodes, used for treating severe psychiatric disturbances by inducing in the patient a major motor seizure by applying a brief intense electrical current to the patient's head.
Special Controls
*Classification.* (1) Class II (special controls) when the device is intended to treat catatonia or a severe major depressive episode (MDE) associated with major depressive disorder (MDD) or bipolar disorder (BPD) in patients age 13 years and older who are treatment-resistant or who require a rapid response due to the severity of their psychiatric or medical condition. The special controls for this device are:(i) The technical parameters of the device, including waveform, output mode, pulse duration, frequency, train delivery, maximum charge and energy, and the type of impedance monitoring system must be fully characterized to ensure that the device performance characteristics are consistent with existing clinical performance data.
(ii) Non-clinical testing data must confirm the electrical characteristics of the output waveform.
(iii) Components of the device that come into human contact must be demonstrated to be biocompatible.
(iv) Performance data must demonstrate electrical and mechanical safety and the functioning of all safety features built into the device including the static and dynamic impedance monitoring system.
(v) Appropriate analysis/testing must validate electromagnetic compatibility.
(vi) Appropriate software verification, validation, and hazard analysis must be performed.
(vii) Performance data must demonstrate electrical performance, adhesive integrity, and physical and chemical stability of the stimulation electrodes.
(viii) The labeling for the device must include the following:
(A) Information related to generic adverse events associated with electroconvulsive therapy device (ECT) treatment;
(B) Instructions must contain the following specific recommendations to the user of the device:
(
*1* ) Conduct of pre-ECT medical and psychiatric assessment (including pertinent medical and psychiatric history, physical examination, anesthesia assessment, dental assessment, and other studies as clinically appropriate);(
*2* ) Use of patient monitoring during the procedure;(
*3* ) Use of general anesthesia and neuromuscular blocking agents;(
*4* ) Use of mouth/dental protection during the procedure;(
*5* ) Use of EEG monitoring until seizure termination;(
*6* ) Instructions on electrode placement, including adequate skin preparation and use of conductive gel; and(
*7* ) Cognitive status monitoring prior to beginning ECT and during the course of treatment via formal neuropsychological assessment for evaluating specific cognitive functions (*e.g.,* orientation, attention, memory, executive function).(C) Clinical training needed by users of the device;
(D) Information on the patient population in which the device is intended to be used;
(E) Information on how the device operates and the typical course of treatment;
(F) A detailed summary of the clinical testing, which includes the clinical outcomes associated with the use of the device, and a summary of adverse events and complications that occurred with the device;
(G) A detailed summary of the device technical parameters;
(H) Where appropriate, validated methods and instructions for reprocessing of any reusable components;
(I) The following statement, prominently placed: “Warning: ECT device use may be associated with: disorientation, confusion, and memory problems”; and
(J) Absent performance data demonstrating a beneficial effect of longer term use, generally considered treatment in excess of 3 months, the following statement, prominently placed: “Warning: When used as intended this device provides short-term relief of symptoms. The long-term safety and effectiveness of ECT treatment has not been demonstrated.”
(ix) Patient labeling must be provided and include:
(A) Relevant contraindications, warnings, precautions;
(B) A summation of the clinical testing, which includes the clinical outcomes associated with the use of the device, and a summary of adverse events and complications that occurred with the device;
(C) Information on how the device operates and the typical course of treatment;
(D) The potential benefits;
(E) Alternative treatments;
(F) The following statement, prominently placed: “Warning: ECT device use may be associated with: Disorientation, confusion, and memory problems”;
(G) Absent performance data demonstrating a beneficial effect of longer term use, generally considered treatment in excess of 3 months, the following statement, prominently placed: “Warning: When used as intended this device provides short-term relief of symptoms. The long-term safety and effectiveness of ECT treatment has not been demonstrated”; and
(H) The following statements on known risks of ECT, absent performance data demonstrating that these risks do not apply:
(
*1* ) ECT treatment may be associated with disorientation, confusion and memory loss, including short-term (anterograde) and long-term (autobiographical) memory loss following treatment. Based on the majority of clinical evidence, these side effects tend to go away within a few days to a few months after the last treatment with ECT. Although the incidence of permanent cognitive memory loss was not supported by the clinical literature, some patients have reported a permanent loss of memories of personal life events (*i.e.,* autobiographical memory);(
*2* ) Patients treated with ECT may experience manic symptoms (including euphoria and/or irritability, impulsivity, racing thoughts, distractibility, grandiosity, increased activity, talkativeness, and decreased need for sleep) or a worsening of the psychiatric symptoms they are being treated for; and(
*3* ) The physical risks of ECT may include the following (in order of frequency of occurrence):(
*i* ) Pain/somatic discomfort (including headache, muscle soreness, and nausea);(
*ii* ) Skin burns;(
*iii* ) Physical trauma (including fractures, contusions, injury from falls, dental and oral injury);(
*iv* ) Prolonged or delayed onset seizures;(
*v* ) Pulmonary complications (hypoxemia, hypoventilation, aspiration, upper-airway obstruction);(
*vi* ) Cardiovascular complications (cardiac arrhythmias, heart attack, high or low blood pressure, and stroke); and(
*vii* ) Death.(2)
*Classification:* Class III (premarket approval) for the following intended uses: schizophrenia, bipolar manic states, schizoaffective disorder, schizophreniform disorder, and catatonia or a severe MDE associated with MDD or BPD in:(i) Patients under 13 years or
(ii) Patients 13 years and older who are not treatment-resistant or who do not require a rapid response due to the severity of their psychiatric or medical condition.
(c)
*Date premarket approval application (PMA) or notice of completion of product development protocol (PDP) is required.* A PMA or notice of completion of a PDP is required to be filed with FDA on or before March 26, 2019, for any electroconvulsive therapy device with an intended use described in paragraph (b)(2) of this section, that was in commercial distribution before May 28, 1976, or that has, on or before March 26, 2019, been found to be substantially equivalent to any electroconvulsive therapy device with an intended use described in paragraph (b)(2) of this section, that was in commercial distribution before May 28, 1976. Any other electroconvulsive therapy device with an intended use described in paragraph (b)(2) of this section shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.
Predicate Devices
MECTA Models 5000 Q, 5000 M, 4000 Q, 4000 M (K960754)
Submission Summary (Full Text)
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A final order reclassifying electroconvulsive therapy (ECT) indicated for use in treating catatonia or a severe major depressive episode (MDE) associated with major depressive disorder (MDD) or bipolar disorder (BPD) in patients age 13 years and older who are treatment-resistant or who require a rapid response due to the severity of their psychiatric or medical condition, a preamendments Class III device, into class II (special controls), was published on December 26, 2018. See here: https://www.federalregister.gov/documents/2018/12/26/2018-27809/neurological-devices-reclassification-of-electroconvulsive-therapy-devices-effective-date-of
This final order also required that that ECT devices intended for the following will remain Class III devices and would not be appropriate for the premarket notification pathway (510(k)), instead requiring a premarket approval (PMA): schizophrenia, bipolar manic states, schizoaffective disorder, schizophreniform disorder, and catatonia or a severe MDE associated with MDD or BPD in:
i. Patients under 13 years; or
ii. Patients 13 years and older who are not treatment-resistant or who do not require a rapid response due to the severity of their psychiatric or medical condition.
While the device submitted and cleared through K965070 may serve as a valid predicate device for a new ECT device, please refer to the aforementioned final order for current regulatory requirements for this device type.
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FDA U.S. FOOD & DRUG ADMINISTRATION
July 22, 2021
Mecta Corp.
Robin H. Nicol
President
7015 S.W. Mc Ewan Rd.
Lake Oswego, Oregon 97035
Re: K965070
Trade/Device Name: Spectrum 5000 Q, 5000 M, 4000 Q, 4000 M.
Regulation Number: 21 CFR 882.5940
Regulation Name: Electroconvulsive therapy device
Regulatory Class: Class II
Product Code: QGH
Dear Robin H. Nicol:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated March 6, 1997. Specifically, FDA is updating this SE Letter to reflect an administrative correction corresponding to the reclassification of electroconvulsive therapy (ECT) intended to treat catatonia or a severe major depressive episode (MDE) associated with major depressive disorder (MDD) or bipolar disorder (BPD) in patients age 13 years and older who are treatment-resistant or who require a rapid response due to the severity of their psychiatric or medical condition, a preamendments class III device, into class II (special controls), as detailed in the final order published on December 26, 2018 (see here: https://www.federalregister.gov/documents/2018/12/26/2018-27809/neurological-devices-reclassification-of-electroconvulsive-therapy-devices-effective-date-of). ECT devices intended for the following will remain Class III devices and would not be appropriate for the premarket notification pathway (510(k)), instead requiring a premarket approval (PMA): schizophrenia, bipolar manic states, schizoaffective disorder, schizophreniform disorder, and catatonia or a severe MDE associated with MDD or BPD in:
i. Patients under 13 years; or
ii. Patients 13 years and older who are not treatment-resistant or who do not require a rapid response due to the severity of their psychiatric or medical condition.
As a result of the final order, FDA has created a new product code (QGH) to better categorize ECT devices intended to treat catatonia or a severe major depressive episode (MDE) associated with major depressive disorder (MDD) or bipolar disorder (BPD) in patients age 13 years and older who are treatment-resistant or who require a rapid response due to the severity of their psychiatric or medical condition.
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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K965070 - Robin H. Nicol
Page 2
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Pamela Scott, OHT5: Office of Neurological and Physical Medicine Devices, 301-796-5433, PamelaD.Scott@fda.hhs.gov.
Sincerely,
Vivek J. Pinto -S
Vivek Pinto, PhD
Director
DHT5B: Division of Neuromodulation
and Physical Medicine Devices
OHT5: Office of Neurological
and Physical Medicine Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850
Ms. Robin H. Nicol
President
MECTA Corporation
7015 SW McEwan Road
Lake Oswego, Oregon 97035
MAR - 6 1997
Re: K965070
Trade Name: spECTrum 5000 and 4000 ECT Devices
Regulatory Class: III
Product Code: 84GXC
Dated: December 10, 1996
Received: December 11, 1996
Dear Ms. Nicol:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Ms. Robin H. Nicol
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for *in vitro* diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Callahan, Ph.D.
Director
Division of Cardiovascular, Respiratory, and Neurological Devices
Office of Device Evaluation
Center for Devices and Radiological Health
Enclosure
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Page ___ of ___
0
510(k) Number (if known): K965070
( )ice Name: spECTrum 5000, 4000 ECT devices
Indications For Use:
Treatment of "severe depression" or "major depressive episode with melancholia".
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number K965070
Description Use: X
Per 21 CFR 801.1091
OK
Over-the-Counter Use: ___
(Optional Format 1-2-96)
32
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K965070
MAR - 6 1997
# SECTION ONE
## 510K Summary
a. NAME OF DEVICE-spECTrum 5000 Q, 5000 M, 4000 Q, 4000 M.
b. CLASSIFICATION DEVICE - Electroconvulsive Therapy Device.
c. ESTABLISHMENT REGISTRATION NUMBER - 3020533
d. ADDRESS OF MANUFACTURING FACILITIES
7015 SW McEwan Road
Lake Oswego, Oregon 97035
e. CLASS IN WHICH DEVICE HAS BEEN PLACED-Class III
f. REASON FOR PREMARKET MODIFICATION-Device modification which is substantially equivalent to the predicate device - spECTrum 5000/4000 K960754
g. IDENTIFICATION OF A LEGALLY MARKETED DEVICE TO WHICH CLAIM EQUIVALENCE- MECTA Models 5000 Q, 5000 M, 4000 Q, 4000M (same K# 960754)
h. NOT APPLICABLE
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4
# 510K SUMMARY
## IDENTIFICATION OF LEGALLY MARKETED DEVICE
The legally marketed devices are the MECTA Models 5000 Q, 5000 M, 4000 Q, and 4000 M ECT devices with parameter ranges identical to those of the MECTA SR and JR ECT devices.
## DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION
The enhanced MECTA spECTrum Models 5000 Q, 5000 M, 4000 Q, and 4000 M ECT devices* will be identical to the currently legally marketed versions in every way except they will provide the clinician with slightly different parameter range options.
The spECTrum series products continue to be the state of the art ECT devices technically. The 5000 devices offer up to six channels of monitoring of ECG and EEG and one Optical Motion Sensor while the 4000 devices are only the ECT module of the 5000 devices. As such, they are upgradeable to the 5000 series units. The 5000 Q and 4000 Q offer the user flexibility with four stimulus parameters to vary energy and charge. The 5000 M and 4000 M offer the user simplicity with one single Stimulus Intensity knob which varies frequency and duration simultaneously, again varying energy and charge.
The touch screen provides the user with an interface to set pre-treatment parameters. This provides the user with more flexibility as he can access all menus by simply touching a screen. The LCD which illuminates the touch screen provides the user with alphanumeric that lead him through self-test, treatment, and monitoring of the EEG, ECG, and OMS. The LCD/touch screen includes choices of eight set-up menus in the 5000 series and one menu in the 4000 series that can help to individualize each patient's treatment in order to enhance the efficacy of each treatment. The LCD/touch screen also provides the user with more data that can be recorded on the patient's record regarding the self test and treatment to ensure greater safety. Also, up to four channels of monitoring can be seen on the LCD-touch screen.
The two channel thermal chart recorder continues to provide the user with a hard copy of the self test and treatment results. The simplicity of the chart recorder only requires the user to set two gain knobs as the self test and treatment results are printed automatically. The manual on/off push button offers the user the option of manually controlling this printing also. The printout continues to provide two channels of monitoring and also provides the user with elapsed time, date, time of treatment, and patient name. The four stimulus parameters on the M series and Q series are shown on the LCD/Touch Screen and the continuous updating of the percent energy on the M series helps to increase efficacy of treatment.
Several features designed to IEC 601-2-14 standards offer the user enhanced safety during the self test and treatment and as such are an advance. The hinged cover on the Stimulus Control push button prevents the user from accidentally treating. The Stimulus Status LED is illuminated to offer the user a visual confirmation that the spECTrum is enabled, that the stimulus is being delivered and finally indicates if there is a stimulus delivery fault. The three warning tones during self test and the constant tone during treatment continue to offer the user enhanced safety during the treatment process. The continuous self-test offers the user far greater accuracy in avoiding aborted or missed seizures as this bio-feedback provides him with measurements continuously which results in far greater efficacy.
The data that can now be provided to the user with the two new features of the spECTrum series now leads to even greater patient safety. The EEG data which provides analyses on seizure adequacy** and stimulus level** allows the clinician to better assess the quality and efficacy of each individual seizure. The Optical Motion Sensor (OMS) allows the user to monitor motor
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5
movement during the seizure and provide further valuable information in assessing seizure efficacy.
The event timer, and the leads off information all provide added information for the clinician which allows him to better assess and improve clinical efficacy. The event timer is printed on the chart recorder as a permanent record. The leads off feature documents that the EEG or ECG leads are off and notifies the user by providing a message on the LCD Touch Screen.
All of the above features demand the most advanced technical design to accommodate them and to meet the most stringent domestic and international standards UL 544, CSA 22.2 125, and TUV EC IEC 601-1 (601-2-14 for electroconvulsive therapy devices), all of which result in far greater safety in the 4000 and 5000 devices to comply with these standards. These approvals are pending and in process at this time. As such they are safer as the TUV standard is the most stringent safety agency internationally. The spECTrum series devices include extensive redundant hardware and software testing and verification that they are operating correctly. The safety of these devices is unparalleled and as such are an advance that will impact the safety and efficacy of the ECT treatment dramatically.
As the technical advances have been a result of the field's demand for greater information, efficacy, and safety, the clinical advances have primarily been ongoing in the field over the last twenty-three years of MECTA's device history. The 5000/4000 series continues to use the constant current bi-directional square waveform, while the starter kit includes improved hand-held electrodes. Again, these have been redesigned with the redundant safety features required to meet the above mentioned standards. Patents are pending on the features identified with an asterisk.
* US PATENT PENDING
** US PATENT PENDING
## THE INTENDED USE OF THIS DEVICE
The intended use of the MECTA spECTrum ECT device is solely for the treatment of "severe depression" or "major depressive episode with melancholia". (ref 21 CFR Part 882 Part III) The clinical setting is in hospital ECT suites, Operating Rooms, or on patient wards.
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.
