Prism Acquire® / Prism Process® software is 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. Prism View® software provides visualization of anatomical with functional and physiologic imaging data sets. Prism Acquire 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 Prism Process, which performs post-processing for quality control and subsequent viewing 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 physiologic MR imagery including magnetic resonance spectroscopy (MRS), MR perfusion, and MR diffusion. Prism View provides both analysis and viewing capabilities that promote the integration of anatomical with physiologic and functional imaging data sets including blood oxygen level dependent (BOLD) fMRI, magnetic resonance spectroscopy (MRS), MR perfusion, and MR diffusion including diffusion tensor imaging (DTI). The integration of these data, when interpreted by a trained physician, yields information that may assist in the diagnosis of central nervous system pathology and the planning and monitoring of medical treatments.
Device Story
System comprises three software modules: Acquire, Process, and View. Acquire presents synchronized visual/auditory stimuli or cognitive/motor tasks to patients during MRI scanning; captures patient responses. Process performs post-processing and quality assurance on fMRI, MRS, perfusion, and diffusion data. View enables visualization and integration of anatomical, functional, and physiologic imagery; supports DTI tractography, volume rendering, and image registration (MR, CT, PET). Used in clinical settings by trained physicians to assist in CNS pathology diagnosis and treatment planning. Infrastructure supported by Prism Flow for DICOM communication, authentication, and audit logging. Output provides integrated imaging data for physician interpretation to guide clinical decision-making.
Clinical Evidence
Bench testing only. Software verification and validation conducted to confirm functionality of new features and ensure no new safety hazards compared to predicate.
Technological Characteristics
Software-based system for MR data acquisition, processing, and visualization. Features include scripted stimulus presentation, image registration, DTI tractography, volume rendering, and support for BOLD fMRI, MRS, perfusion, and diffusion. Connectivity via DICOM-compliant server-based infrastructure (Prism Flow).
Indications for Use
Indicated for patients undergoing MRI scans to assist trained physicians in diagnosing central nervous system pathology and planning/monitoring medical treatments via integration of anatomical, functional, and physiologic MR data (BOLD fMRI, MRS, perfusion, diffusion, DTI).
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.
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K122026
SEP 2 1 2012
### Special 510(k) Summary б
- Prism Acquire®, Prism Process®, Prism View® K
#### 1. Contact Information
Submitter Contact Person Prism Clinical Imaging, Inc. James L. Reuss, Ph.D. (CTO) 890 Elm Grove Rd. Ste. 215 Phone 262-754-3840 Elm Grove, WI 53122 Fax 262-754-3839
Date Summary Prepared: June 21, 2012
#### 2. Device Name and Classification
| Trade Name | Classification Name | Class | Product Code |
|---------------|----------------------------------------------------------------|-------|--------------|
| Prism Acquire | 892.1000, "Radiology, Magnetic<br>Resonance Diagnostic Device" | II | LNH |
| Prism Process | 892.1000, "Radiology, Magnetic<br>Resonance Diagnostic Device" | II | LNH |
| Prism View | 892.2050, "Picture archiving and<br>communications systems" | II | LLZ |
#### 3. Identification of Legally Marketed Modified Predicate Device
| Predicate System | Manufacturer | Reg. Data |
|---------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------|
| Prism Acquire®,<br>Prism Process®,<br>Prism View® | Prism Clinical Imaging, Inc.<br>890 Elm Grove Rd. Ste. 215<br>Elm Grove, WI 53122<br>(f/k/a Kyron Clinical Imaging) | K082964<br>SE 2/20/2009<br>Product code LNH, LLZ<br>Class II |
#### 4. Description of Device
Prism Acquire provides a scripted approach to performing fMRI and other imaging studies. Prism Process performs post-processing and quality assurance of fMRI and other imaging data sets. The processed data is prepared for report generation utilizing the Prism View product, supporting the visualization and manipulation of clinical imagery of multiple kinds. It provides a flexible set of display, analysis, and export options for utilizing the imagery relationships.
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These applications may communicate in the healthcare IT environment via Prism Flow®, server-based software facilitating DICOM communications, authorization/authentication, audit logging, and other infrastructure functions.
#### 5. Statement of Intended Use
Prism Acquire® / Prism Process® software is 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. Prism View® software provides visualization of anatomical with functional and physiologic imaging data sets.
Prism Acquire 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 Prism Process, which performs post-processing for quality control and subsequent viewing 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 physiologic MR imagery including magnetic resonance spectroscopy (MRS), MR perfusion, and MR diffusion.
Prism View provides both analysis and viewing capabilities that promote the integration of anatomical with physiologic and functional imaging data sets including blood oxygen level dependent (BOLD) fMRI, magnetic resonance spectroscopy (MRS), MR perfusion, and MR diffusion including diffusion tensor imaging (DTI).
The integration of these data, when interpreted by a trained physician, yields information that may assist in the diagnosis of central nervous system pathology and the planning and monitoring of medical treatments.
#### 6. Predicate Device Comparison of Technological Characteristics
The intended uses and technological characteristics of Prism Acquire. Process and View are the same as the respective predicate devices. Incremental revisions to the software have been made, including the following:
- 1) Expanded selection of fMRI paradigms, including additional natural languages;
- 2) Improved tools for report workflow, including report creation and addition of image data to existing reports;
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- 3) Expanded registration of MR, CT, and PET image combinations, including handling of scanner obliquity;
- 4) Enhancement of DTI visualization to include additional parameter maps and diffusion tensor tractography (DTT);
- 5) Addition of volume rendering and track markups to 3D visualization options:
- 6) Support for MR Arterial-Spin Labeled (ASL) perfusion images in the MR perfusion visualization;
- 7) Expanded selection of image markup tools.
None of these features represent fundamentally new scientific technology.
#### 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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Image /page/3/Picture/0 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle. The seal is simple and monochromatic.
## DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
SEP. 21 2012
James L. Reuss, PhD Chief Technology Officer Prism Clinical Imaging, Inc. 890 Elm Grove Road. Suite 215 ELM GROVE WI 23122
Re: K122026
Trade/Device Name: Prism Acquire®, Prism Process®, Prism View® Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH and LLZ Dated: August 23, 2012 Received: August 29, 2012
### 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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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 or uny 1 outlar statutes and including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter requirements as bet form in the your device as described in your Section 510(k) premarket while anow Jour to began mading of your device 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 Parts 801 and 11 you deen contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the I va may of amall Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Janine M. Morris
Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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### 5 Indications For Use
510(k) Number (if known): K
Device Name:
Prism Acquire®, Prism Process®, Prism View®
# INDICATIONS FOR USE:
Prism Acquire® / Prism Process software is 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. Prism View software provides visualization of anatomical with functional and physiologic imaging data sets.
Prism Acquire 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 MRJ scanner are stored for use by Prism Process, which performs post-processing for quality control and subsequent viewing 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 physiologic MR imagery including magnetic resonance spectroscopy (MRS), MR perfusion, and MR diffusion.
Prism View provides both analysis and viewing capabilities that promote the integration of anatomical with physiologic and functional imaging data sets including blood oxygen level dependent (BOLD) fMRI, magnetic resonance spectroscopy (MRS), MR perfusion, and MR diffusion tensor imaging (DT),
The integration of these data, when interpreted by a trained physician, yields information that may assist in the diagnosis of central nervous system pathology and the planning and monitoring of medical treatments.
Prescription Use X (Per 21 CFR 801 Subpart D) OR
Over-the-Counter Use (Per 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prism Clinical Imaging, Inc.
ર-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.
