MRI- MAGNETIC RESONANCE ANALYTICAL SOFTWARE SYSTEM
K994283 · Medis Medical Imaging Systems BV · LNH · Aug 30, 2000 · Radiology
Device Facts
Record ID
K994283
Device Name
MRI- MAGNETIC RESONANCE ANALYTICAL SOFTWARE SYSTEM
Applicant
Medis Medical Imaging Systems BV
Product Code
LNH · Radiology
Decision Date
Aug 30, 2000
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 892.1000
Device Class
Class 2
Attributes
Software as a Medical Device
Indications for Use
MASS, including its option, has been developed for the objective and reproducible analysis of multi-slice, multi-phase left and right ventricular from cardiac MR data sets. The software enables the display of images for use by trained medical personnel. Intended purposes are: supporting clinical diagnoses about the status of the global and regional function and anatomy of the cardiac chambers; supporting the subsequent clinical decision making processes; supporting the use in clinical research trials, directed at studying changes in function and anatomy of the heart chambers as a result of interventions.
Device Story
MASS is analytical software for UNIX/Linux platforms; imports multi-slice, multi-phase MRI cardiac data via CD-ROM or network. Device performs semi-automatic calculation of ventricular parameters (volumes, mass, wall thickness/motion). Clinicians (cardiologists, radiologists) review generated contours and measurements; operator may accept or reject outlines. Output supports clinical diagnosis, decision-making, and research trials regarding cardiac function and anatomy. Benefits include objective, reproducible assessment of heart chambers independent of MRI vendor.
Clinical Evidence
No clinical data provided. Safety and effectiveness supported by risk management plan, hazard analysis, verification and validation testing, and hospital evaluations/literature review.
Technological Characteristics
Software-based analytical tool for UNIX/Linux platforms. Facilitates import/visualization of MRI data. Performs semi-automatic contouring and quantification of cardiac parameters. Standalone software; vendor-independent. Level of concern: minor.
Indications for Use
Indicated for trained medical personnel to perform objective, reproducible analysis of multi-phase left and right ventricular function from cardiac MR data sets. Used to calculate parameters including EDV, ESV, stroke volume, ejection fraction, myocardial mass, regional wall thickness, wall thickening/thinning, and regional wall motion to support clinical diagnosis.
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
QLV-CMS (Quantitative Left Ventriculography-Cardiovascular Measurement System) (K993765)
Submission Summary (Full Text)
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K994283
AUG 3 0 2000
**medical imaging systems**
# 510(k) Premarket Notification
12 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Submission in accordance with the requirements of 21 CFR Part 807.87(h)
| 1) Submitter | : MEDIS medical imaging systems B.V. |
|----------------|-----------------------------------------------------------------------|
| Address | : Poortgebouw, Rijnsburgerweg 10<br>: 2333 AA Leiden, The Netherlands |
| Telephone | : +31 71 522 3244 |
| Fax | : +31 71 521 5617 |
| Contact Person | : J.I. Hollander, Quality Coordinator |
| Prepared | : December 15, 1999 |
| 2) Device Name | : MRI - Magnetic resonance Analytical Software System |
| Common Name | : MASS |
Device Class. Name Regulation Number
System, Image Processing; : 21 CFR 892.2050 (90 LLZ; Class II)
. Medis: 510(k) K993765; 3) Predicate Device(s)
4) Description of the device:
MASS is a professional state-of-the-art analytical software tool designed for UNIX as well as Linux platforms. MASS facilitates the import and visualization of multi-slice, multiphase MRI data sets encompassing the cardiac chambers via CD-Rom and digital network. This MASS functionality is independent of the MRI equipment vendor. MASS provides objective and reproducible global and regional two-, three- and fourdimensional clinically relevant parameters describing left and right ventricular heart as ventricular volumes, regional wall thickness and function. such wall MASS is intended to support all clinicians, i.e. cardiologists, thickening/thinning radiologists, and referring physicians involved in the noninvasive assessment of heart function.
### 5) Intended use:
MASS, including its option, has been developed for the objective and reproducible analysis of multi-slice, multi-phase left and right ventricular from cardiac MR data sets. The software enables the display of images for use by trained medical personnel.
Intended purposes are:
supporting clinical diagnoses about the status of the global and regional function and ﮩ anatomy of the cardiac chambers;
2. supporting the subsequent clinical decision making processes;
supporting the use in clinical research trials, directed at studying changes in function and anatomy of the heart chambers as a result of interventions.
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medical imaging syst
# MRI- MASS 510(k) Premarket Notification
## 6) Substantial equivalence Information:
MASS is substantially equivalent to the Predicate Devices of MEDIS medical imaging systems B.V., K993765 "QLV-CMS" (Quantitative Left Ventriculography-Cardiovascular Measurement System)
# Conclusion respecting safety and effectiveness:
It is the opinion of MEDIS medical imaging systems B.V. that MASS is safe and potential hazards are controlled by a risk management plan for the software development procease (see Appendix C), Including hazard analysis (see Appendix D), verification and validation tests (see Appendix E). Evaluations by hospitals and literature (see Appendix F) support this statement. The software package MASS itself will not have any adverse effects on health. This tool calculates and displays the anatomy and function of the left and right ventricular contours and regions and regions-of-interest will be interpreted by the operator, who can choose to accept or reject the outlines, and then decide to use the derived data to compare against earlier images or images from other patients.
in MEDIS opinion the level of concern for the stand alone software to view images is 'minor' and that the use of MASS software does not change the intended use of magnetic resonance scanners in practice, nor does the use of software result in any new potential hazards.
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## DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of three stylized human figures.
## Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 3 0 2000
Mr. J. I. Hollander Quality Coordinator MEDIS Medical Imaging Systems B.V. Poortgebouw Rijnsburgerweg 10 2333 AA Leiden NETHERLANDS
Re: K994283 MRI-MASS (analytical software) Dated: June 22, 2000 Received: June 26, 2000 Regulatory Class: II 21 CFR §892.1000/Procode: 90 LNH
#### Dear Mr. Hollander:
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 legally marketed predicate devices marketed in interstate commerce pror 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 and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class III (Premarket Aproval), 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 equivalion assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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 Radiation Control provisions, or other Federal laws or regulations.
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) 594-4591. 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" (21CFR 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/dsma/dsmamain.html".
Sincerely yours,
Daniel C. Schultz, M.D.
Daniel G. Schultz, M.D. Captain, USPHS Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
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510(k) Number (if known):
Device Name:
Indications For Use:
MASS, including its option, has been developed for the objective and reproducible analysis of multi-shase left and right ventricular function from cardiac MR data sets. The MASS software package can be used to semi-automatically calculate and display various parameters such as: EDV, ESV, stroke volume, ejection fraction, peak thisksping(this) = = = = ; myocardial mass; regional wall thickness, as well as wall thickening/thinning, and regional wall motion.
When interpreted by a trained physician these parameters may be useful in supporting the determination of a diagnosis.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| | Concurrence of CDRH, Office 9&Device Evaluation (ODE) | | |
|---------------|---------------------------------------------------------------------------------------------------------------------|---|--|
| | 1<br>(Division Sign-Off)<br>Division of Reproductive, Abdominal, ENT,<br>and Radiological Devices<br>510(k) Number_ | | |
| scription Use | OD | A | |
Pres (Per 21 CFR 801.109)
S
Over-The-Counter Use
(Optional Format 1-2-96)
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.
