BRAINACQUIRERX / BRAINPROCESSRX DATA SUITE VERSION 1.0
K061255 · Kyron Clinical Imaging, Inc. · LNH · Jun 13, 2006 · Radiology
Device Facts
Record ID
K061255
Device Name
BRAINACQUIRERX / BRAINPROCESSRX DATA SUITE VERSION 1.0
Applicant
Kyron Clinical Imaging, Inc.
Product Code
LNH · Radiology
Decision Date
Jun 13, 2006
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 892.1000
Device Class
Class 2
Attributes
Software as a Medical Device
Indications for Use
The BrainAcquireRx™ / BrainProcessRx™ Data Suite is software used in conjunction with a Magnetic Resonance scanner to acquire and process blood oxygen level dependent (BOLD) functional magnetic resonance imaging (fMRI) and other MRI data sets. The BrainAcquireRx software application presents a scripted series of synchronized visual and/or auditory stimuli and/or cognitive/motor tasks to the patient being scanned. The patient's responses and image data from the MRI scanner are stored for use by the BrainProcessRx application, which performs post-processing for quality control and subsequent viewing of fMRI and other MRI data. These applications can also be used to assist in scripted data acquisition and post-processing of anatomical, functional, and physiologic MR imagery including magnetic resonance spectroscopy (MRS) and MR diffusion. The integration of these data, when interpreted by a trained physician, yields information that may assist in the diagnosis of brain pathology and the planning and monitoring of medical treatments.
Device Story
Software suite for fMRI and MRI data management; operates on PC. BrainAcquireRx presents synchronized visual/auditory stimuli and cognitive/motor tasks to patients during MRI scanning; captures patient responses and scanner image data. BrainProcessRx performs post-processing, quality control, and data preparation for viewing. Used in clinical settings by trained physicians to assist in diagnosing brain pathology and planning/monitoring treatments. Provides integrated anatomical, functional, and physiologic data (including MRS and diffusion) for physician interpretation.
Clinical Evidence
Bench testing only. Software verification and validation were conducted to confirm proper function of device features. No clinical data presented.
Technological Characteristics
PC-based software suite for MRI data acquisition and post-processing. Functions include stimulus presentation, data storage, quality control, and image viewing. Supports BOLD fMRI, MRS, and MR diffusion. No specific hardware materials or energy sources defined as it is software-only.
Indications for Use
Indicated for patients undergoing MRI scans to acquire and process BOLD fMRI, MRS, and MR diffusion data. Used to assist trained physicians in the diagnosis of brain pathology and the planning and monitoring of medical treatments.
Regulatory Classification
Identification
A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).
Special Controls
*Classification.* Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
Predicate Devices
Eloquence Integrated Functional Imaging System (K023130)
MindState™ Functional Data Acquisition Device (fDAD™) (K043290)
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Kob/255
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## 5 510(k) Summary
JUN 1 3 2006 - BrainAcquireRx™ / BrainProcessRx™ Data Suite K
### Contact Information 1.
- Contact Person Submitter James L. Reuss, Ph.D. (CTO) Kyron Clinical Imaging, Inc. 2457 N. Mayfair Rd., Suite 202 Phone 414-727-1930 414-727-1939 Wauwatosa, WI 53226 Fax
Date Summary Prepared: May 1st, 2006
#### 2. Device Name and Classification
The proprietary name of the device to be introduced into interstate commerce is the BrainAcquireRx™ / BrainProcessRx™ Data Suite. It is image reconstruction and processing software running on a personal computer, classified under product code 90 LNH (regulation # 892.1000), "Radiology, Magnetic Resonance Diagnostic Device" as a class II medical device.
#### Identification of Legally Marketed Equivalent Predicate Devices 3.
| Predicate System | Manufacturer | Reg. Data |
|-------------------------------------------------------------|-------------------------------------------------------------------------------|----------------------------------------------------------|
| Eloquence Integrated<br>Functional Imaging<br>System | MRI Devices Corp.<br>1515 Paramount Dr.<br>Waukesha, WI 53186 | K023130<br>SE 10/11/2002<br>Product code LNH<br>Class II |
| MindState™ Functional<br>Data Acquisition Device<br>(fDAD™) | Neurognostics, Inc.<br>10437 Innovation Dr., Suite 309<br>Milwaukee, WI 53226 | K043290<br>SE 1/28/2005<br>Product code LNH<br>Class II |
| Syngo® Multimodality<br>Workstation | Siemens Medical Systems<br>186 Wood Ave. South<br>Iselin, NJ 08830 | K010938<br>SE 6/26/2001<br>Product code LLZ<br>Class II |
| Diffusion tensor imaging<br>option for MRI | GE Medical Systems<br>P.O. Box 414, W-709<br>Milwaukee, WI 53201 | K003573<br>SE 1/23/2001<br>Product code LNH<br>Class II |
#### Description of Device 4.
The software provides support for functional MRI (fMRI) data acquisition and post-processing, as well as other anatomical, functional and physiologic MRI
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studies. BrainAcquireRx provides a scripted approach to performing fMRI and other functional, anatomical and physiologic MRI studies. BrainProcessRx performs post-processing of fMRI and other data sets. The processed data is ready for report generation utilizing the Kyron BrainViewRx™ Viewer.
#### Statement of Intended Use 5.
"The BrainAcquireRx™ / BrainProcessRx™ Data Suite is software used in conjunction with a Magnetic Resonance scanner to acquire and process blood oxygen level dependent (BOLD) functional magnetic resonance imaging (fMRI) and other MRI data sets.
The BrainAcquireRx software application presents a scripted series of synchronized visual and/or auditory stimuli and/or cognitive/motor tasks to the patient being scanned. The patient's responses and image data from the MRI scanner are stored for use by the BrainProcessRx application, which performs post-processing for quality control and subsequent viewing of fMRI and other MRI data. These applications can also be used to assist in scripted data acquisition and post-processing of anatomical, functional, and physiologic MR imagery including magnetic resonance spectroscopy (MRS) and MR diffusion. The integration of these data, when interpreted by a trained physician, yields information that may assist in the diagnosis of brain pathology and the planning and monitoring of medical treatments."
#### 6. Predicate Device Comparison of Technological Characteristics
The BrainAcquireRx application contains fMRI stimulus, acquisition and postprocessing capabilities that are substantially equivalent to the software provided with the MRI Devices Eloquence and the Neurognostics MindState workstations. BrainProcessRx also performs post-processing of other MRI data sets substantially equivalent to the MRI data post-processed by the Siemens syngo software and GE DTI option.
#### 7. Performance Study
FDA has not established special controls or performance standards for this device. Software verification and validation was conducted to confirm proper function of the device's features.
#### 8. Safety information
No new safety hazards are introduced by the use of the device in comparison to the software of the predicate devices.
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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
JUN 1 3 2006
James L. Reuss, Ph.D. Chief Technology Officer Kyron Clinical Imaging, Inc. 2457 N. Mayfair Rd., Suite 202 WAUWATOSA WI 53226
Re: K061255
Trade/Device Name: BrainAcquireRxTM / BrainProcessRxTM Data Suite Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: May 1, 2006 Received: May 4, 2006
Dear Dr. Reuss:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150
or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely vours.
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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## Indications For Use 4
510(k) Number (if known): K U
BrainAcquireRx™ / BrainProcessRx™ Data Suite Device Name:
# INDICATIONS FOR USE:
The BrainAcquireRx™ / BrainProcessRx™ Data Suite is software used in conjunction The DramAcequirettx - 7 Drain 100000 and process blood oxygen level dependent (BOLD) functional magnetic resonance imaging (fMRI) and other MRI data sets.
The BrainAcquireRx software application presents a scripted series of synchronized visual and/or auditory stimuli and/or cognitive/motor tasks to the patient being scanned. The patient's responses and image data from the MRI scanner are stored for use by the I he patient's responses and image sportions post-processing for quality control and Drami rocesses upping of fMRI and other data. These applications can also be used to assist in scripted data acquisition and post-processing of other anatomical, functional and in scripted data acquisition and post nagnetic resonance spectroscopy (MRS) and MR diffusion. The integration of these data, when interpreted by a trained physician, yields information that may assist in the diagnosis of brain pathology and the planning and monitoring of medical treatments.
Over-the-Counter Use OR X Prescription Use (Per 21 CFR 801 Subpart C) (Per 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE - - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Lappin
Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
Kyron™ Clinical Imaging, Inc.
Confidential
4-1
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.
