K040852 · Medical Media Systems, Inc. · LLZ · Apr 23, 2004 · Radiology
Device Facts
Record ID
K040852
Device Name
PREVIEW TREATMENT PLANNING SOFTWARE
Applicant
Medical Media Systems, Inc.
Product Code
LLZ · Radiology
Decision Date
Apr 23, 2004
Decision
SESE
Submission Type
Special
Regulation
21 CFR 892.2050
Device Class
Class 2
Attributes
Software as a Medical Device
Indications for Use
The Preview® Treatment Planning Software is intended to provide accurate, alternative two-dimensional images, as well as three-dimensional models, of patient specific anatomy from existing two-dimensional scan data of organs and tissues. The Preview® product offers the physician the capability to view existing scan data in a format that is more user friendly, and thus enhances the physician's capability to plan treatment. The Preview® product is not intended to provide medical diagnosis or a recommended treatment approach.
Device Story
Software processes existing 2D scan data (CT, MRI) from multiple vendors; generates 2D reformatted images and 3D anatomical models using surface shaded display (SSD). Physician uses software to view, rotate, measure, and manipulate 3D models; features include transparency control, user-placed markers, and surgical plan saving. New features in this version include Manufacturer Specific Virtual Graft (MSVG), 'Click-Drag' manipulation, standardized marks/calculations, and centerline tensioning/morphing. Used in clinical settings to enhance treatment planning; does not provide diagnosis or treatment recommendations.
Clinical Evidence
No clinical data provided; substantial equivalence based on technological characteristics and bench testing comparisons.
Technological Characteristics
Software-based image processing system. Inputs: 2D scan data (CT, MRI). Outputs: 2D reformatted images, 3D models (SSD). Features: 2D/3D measurements, model rotation, transparency control, MSVG, centerline tensioning. Connectivity: Links to hospital networks. Operating platforms: Macintosh OS, DOS/Windows. Software-only device.
Indications for Use
Indicated for physicians to visualize and plan treatment using 2D and 3D anatomical models derived from existing 2D scan data (CT, MRI) of organs and tissues. Not for medical diagnosis or treatment recommendation.
Regulatory Classification
Identification
A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.
Special Controls
*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
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| APR 2 3 2004 | Preview® Treatment Planning Software<br>Summary of Safety and Effectiveness |
|--------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter Name: | Medical Media Systems, Inc<br>K040852 |
| Submitter Address: | 12 Commerce Avenue<br>West Lebanon, NH 03784 |
| Contact Person: | William F. Greenrose<br>Senior Vice President |
| Phone Number:<br>Fax Number: | 603-298-5509 x 303<br>603-298-5055 |
| Date Prepared: | April 1, 2004 |
| Device Trade Name: | Preview® Treatment Planning Software |
| Classification Name,<br>Number & Pro Code: | System, Image Processing, Radiological (21 CFR 892.2050; LLZ) |
| Predicate Device: | Preview™ Surgery Planning Software, by Medical Media Systems, Inc. |
| Device Description<br>and Statement of<br>Intended Use | The Preview® Treatment Planning Software is intended to provide<br>accurate, alternative two-dimensional images, as well as three-<br>dimensional models, of patient specific anatomy from existing two-<br>dimensional scan data of organs and tissues. The Preview® product<br>offers the physician the capability to view existing scan data in a format<br>that is more user friendly, and thus enhances the physician's capability<br>to plan treatment. The Preview® product is not intended to provide<br>medical diagnosis or a recommended treatment approach. |
| Summary of<br>Technological<br>Characteristics | A table comparing the Preview® Treatment Planning Software to the<br>original Preview™ predicate device is attached. |
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| K040852<br>Substantial Equivalence Comparison | | |
|------------------------------------------------------------|---------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|
| Viewing Software | Modified MMS Preview®<br>Treatment Planning<br>Software | Original MMS<br>Preview™ Surgery<br>Planning Software<br>(K# 953616) |
| Imaging technique | SSD | SSD |
| Reformatted 2D images from 2D axial<br>images | Yes | Yes |
| Sequential viewing of 2D images | Yes | Yes |
| Random viewing of 2D slices | Yes | Yes |
| Rendered 3D model | Yes | Yes |
| Multi-color objects in model | Yes | Yes |
| 2D measurements | Yes | Yes |
| 3D measurements | Yes, generated from 2D<br>images. | Yes, same |
| Interactive 3D model | Yes | Yes |
| Rotate model | Yes | Yes |
| Add 2D image to 3D model | Yes | Yes |
| Control transparency of objects in model | Yes | Yes |
| User placed markers in model | Yes. Marks placed in 2D<br>images appear in 3D<br>model. | Yes. Same |
| Color display, 256 colors from 16.7 million<br>Color | Yes | Yes |
| Accept input data from multiple formats<br>(e.g., CT, MRI) | Yes | Yes |
| Accept input data from multiple vendors | Yes | Yes |
| Create & save surgical plans | Yes | Yes |
| Supports mouse & keyboard interface | Yes | Yes |
| Operating platform | Modeling done at MMS on<br>UNIX. Viewing software<br>run on Macintosh OS or<br>DOS/Windows. | Modeling done on<br>Linux platform.<br>Viewing only on<br>Windows OS. |
| Capability to link to hospital computer<br>network | Yes | Yes |
| MSVG feature | Yes | No |
| 'Click-Drag' feature | Yes | No |
| Standardized Mark and Calculation types | Yes | No |
| Centerline Tensioning/morphing | Yes | No |
2D = 2-Dimensional; 3D = 3-Dimensional; SSD = Surface shaded display; MSVG = Manufacturer Specific Virtual Graft
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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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle with three lines representing its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 3 2004
Medical Media Systems, Inc. % Ms. Patsy J. Trisler, J.D., RAC Regulatory Consultant 5610 Wisconsin Avenue, #304 CHEVY CHASE MD 20815
Re: K040852
Trade/Device Name: Preview® Treatment Planning Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and Communication system Regulatory Class: II Product Code: 90 LLZ Dated: March 30, 2004 Received: April 1, 2004
Dear Ms. Trisler:
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 I ou may, there controls 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 (PMA), 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.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r roas be a nood was a determination that your device complies with other requirements of the Act many liederal 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
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This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will allow you to begit marketing your device of your device of your device to a legally
premarket notification. The FDA in a leasifies for your device and thus premarket notification. The FDA inding of substantial of 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 If you desire specific advice for your device on our laboling organized on the regulation number at the top of the letter.
| 8xx.1xxx | (301) 594-4591 |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, for questions on the promotion and the regulation entitled, "Misbranding
Office of Compliance at (301) 594-4639. Also, please note of tags of the general Office of Compliance at (301) 394-4037. Also, production of obtain. Other general
by reference to premarket notification" (21 CER Part 807.97) you may obtain of Sma by reference to premarket notification (21C. I i in 0017779 your de mail.
information on your responsibilities under the Act may be obtained from the Uiving (800) 638-2041 information on your responsibilities under Asstance at its toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance at its toll-free increasing Manufacturers, International and Colisumer / Esistance a creative and contributional dismamain.html.
Sincerely yours,
Nancy C. Brogdon:
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Page 2
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## Indications for Use Statement
510(k) Number (if known):
Ko40852
Device Name:
Preview® Treatment Planning Software
Indications for Use:
The Preview® Treatment Planning Software is intended to provide accurate, The Freviews Treatment Flanning on well as three-dimensional models, of allemative two-dimensional images, as wo-dimensional scan data of organs and patient Specific anatomy from oxisting the and offers the capability to view existing tissues. The i reviews prosunor prosunore user friendly, and thus enhances the SCan data in a formia that is more nent. The Preview® product is not intended to provide medical diagnosis or a recommended treatment approach.
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH; Office of Device Evaluation (ODE) Over-The-Counter OR X Prescription Use Use (Per 21 CFR 801.109) (Optional Format 1-2-96) (Division Sign-Off) Division of Reproductive, Abdon and Radiological Device 510(k) Number _
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.
