K002312 · Varian Medical Systems, Inc. · MUJ · Aug 30, 2000 · Radiology
Device Facts
Record ID
K002312
Device Name
PROTON VISION 7.0
Applicant
Varian Medical Systems, Inc.
Product Code
MUJ · Radiology
Decision Date
Aug 30, 2000
Decision
SESE
Submission Type
Special
Regulation
21 CFR 892.5050
Device Class
Class 2
Attributes
Software as a Medical Device
Indications for Use
The Varian Proton Vision device is a treatment planning system used for diagnostic image analysis, contouring & segmentation, proton energy range estimation and dose compensation, proton dose calculation and plan review.
Device Story
ProtonVision 7.0 is a computer-based treatment planning system for proton radiation therapy. It ingests diagnostic images to perform contouring and segmentation; calculates proton energy range, dose compensation, and dose distribution; and facilitates plan review. Used in clinical settings by radiation oncology staff to prepare 3D treatment plans for proton accelerators (70-235 MeV). The system integrates with the Varian Vision database and SomaVision software to support the overall therapy workflow. Output consists of prospective or verification treatment plans, which clinicians use to guide proton beam delivery, aiming to optimize dose distribution to target tissues while sparing healthy anatomy.
Clinical Evidence
No clinical data provided; bench testing only.
Technological Characteristics
Computer-based software system for radiation therapy planning. Features include diagnostic image analysis, contouring, segmentation, proton energy range estimation, dose compensation, and dose calculation. Integrates with Varian Vision database and SomaVision. Operates on standard computer hardware with graphics display and plotter output.
Indications for Use
Indicated for planning proton radiation therapy treatments using proton accelerators (70-235 MeV). Supports 3D radiotherapy planning for rectangular, circular, regular, and irregular fields using customized blocking and compensators. Includes tools for diagnostic image analysis, contouring, segmentation, and plan review.
Regulatory Classification
Identification
A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.
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K002312
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Image /page/0/Picture/2 description: The image shows the logo for Varian Medical Systems. The logo consists of the word "VARIAN" in bold, uppercase letters. The "I" in "VARIAN" is stylized with a curved top and a dot above it. Below the word "VARIAN" is the phrase "medical systems" in a smaller, sans-serif font.
alo Alto, CA 94304-1038 +1 650 493 4000 w.varian.com
## Premarket Notification [510K] Summary as required by 21 CFR 807.92
Date Summary was prepared; July 26, 2000
#### Submitter's Name:
Varian Medical Systems 3100 Hansen Way Palo Alto, CA 94304
Contact Person: Linda S. Nash Corporate Director, Regulatory Affairs and Quality Assurance (650) 424-6990 Phone FAX (650) 855-7364 E-Mail linda.nash@os.varian.com
Device Name: ProtonVision 7.0
Classification Name: Medical Charged Particle Radiation Therapy Systems
Predicate Device: ProtonVision 7.0, K000922
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K002312
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### Product Description:
The Varian ProtonVision is a computer based device used for calculating and displaying prospective or verification treatment plans for particular patients undergoing a course of proton therapy. The system consists of a computer with graphics display and plotter outp As a Soma Vision (K992751) option, Proton Vision provides the capabilities of diagnostic image analysis, contouring and segmentation. In addition to SomaVision, ProtonVision e and the protone energy range estimation and dose compensation, proton dose
calculation and dosimerice plan review. Proton Vision integrates proton treatment planning
with
## Intended Use:
The Varian Proton Vision device is a treatment planning system used for diagnostic image analysis, contouring & segmentation, proton energy range estimation and dose compensation, proton dose calculation and plan review.
#### Technological Characteristics :
See attached Specification Comparison Chart, Tab F
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 3 0 2000
Ms. Linda S. Nash Corporate Director, Regulatory Affairs and Quality Assurance Varian Medical Systems 3100 Hansen Way M/S E-055 Palo Alto, CA 94304-1129
Re: K002312
Proton Vision 7.0.3 Radiation Therapy Treatment Planning System Dated: July 26, 2000 Received: July 31, 2000 21 CFR §892.5050/Procode: 90 MUJ
Dear Ms. Nash:
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 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, aqainst 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 not ification 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 predication 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 diagnoslic 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/dsmaldsmamain.html".
Sincerely yours.
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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Image /page/3/Picture/0 description: The image shows the logo for Varian Medical Systems. The logo consists of the word "VARIAN" in a serif font, with a stylized "I" that resembles a person. Below the word "VARIAN" is the phrase "medical systems" in a smaller, sans-serif font. The logo is simple and professional, and it conveys a sense of innovation and expertise.
Varian Medical Systems, Inc. 3100 Hansen Way Palo Alto, CA 94304-1038 USA tel +1 650 493 4000 www.varian.com
## Indications For Use
# 510(k) Number: K 002312
Device Name: ProtonVision 7.0
Indications For Use:
The Varian ProtonVision device is used to plan proton radiation therapy treatments employing proton accelerators with energies from 70 to 235 MeV. ProtonVision will plan the 3D radiotherapy proton treatment approaches to rectangle and circular fields, and regular and irregular fields using customized blocking and compensators. ProtonVision includes also tools for treatment preparation (diagnostic image analysis, contouring & segmentation) and plan review.
As part of the Varis Vision System, ProtonVision integrates proton treatment planning in overall therapy process, while taking advantage of the Varian Vision database.
(PLEASE DØ NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K00231
Prescription Use OR (per 21 CFR 801.109)
Over-The-Counter Use_
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.
