K970236 · Theratronics, Inc. · IYE · Jul 9, 1997 · Radiology
Device Facts
Record ID
K970236
Device Name
THERAPLAN PLUS VERSION 1.2
Applicant
Theratronics, Inc.
Product Code
IYE · Radiology
Decision Date
Jul 9, 1997
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 892.5050
Device Class
Class 2
Attributes
Software as a Medical Device
Indications for Use
THERAPLAN Plus Version 1.2 is intended to be used as a modelling system to assist health care professionals determine a course of Radiation Therapy to be delivered to a patient. The software is designed to run on a central host computer and support a number of peripherals and accessories. The system can be configured to enter scan data from various types of CT scanners and MR scanners or to manually enter patient contour outlines. THERAPLAN Plus Version 1.2 systems can be networked together for common access to pertinent data. THERAPLAN Plus Version 1.2 is intended to be used directly by a health care professional capable of assessing the suitability of the output for treatment planning purposes, or to have its output reviewed by someone with these qualifications prior to use.
Device Story
Radiation therapy treatment planning system; inputs patient anatomy via CT/MR images (DICOM or proprietary interface), film scanner, or manual digitizer; models electron/photon beams (accelerators/Cobalt units) and brachytherapy sources (isotopes, wires); performs dose calculations and optimization for external beam and brachytherapy; outputs treatment plans for clinical review. Used in clinical settings by radiation oncology professionals; assists in determining radiation delivery parameters. System runs on Pentium PC with Windows NT; supports networking for data access. Output used by clinicians to finalize treatment plans, potentially improving radiation delivery accuracy and patient outcomes.
Clinical Evidence
No clinical data. Evidence consists of system testing and validation performed in compliance with Theratronics product development procedures to demonstrate that the system meets published specifications and performs equivalently to predicate devices.
Technological Characteristics
Software-based radiation therapy planning system; runs on Pentium PC under Windows NT. Supports DICOM 3.0 and proprietary interfaces for CT/MR image acquisition. Peripherals include electromagnetic digitizer, film scanner, and printers. Features unit/source modelling, anatomy contouring, and dose calculation algorithms. Network-capable for multi-user data access.
Indications for Use
Indicated for use as a modelling system to assist health care professionals in determining a course of radiation therapy for patients with cancer. Intended for use by qualified health care professionals or under their direct 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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THERAPLAN Plus Version 1.2
510(k) Submission
K970236
# Summary of Safety and Effectiveness
**Prepared:** January 17, 1997
**JUL - 9 1997**
**Submitter:** Theratronics International Limited
**Address:** 413 March Road
P. O. Box 13140
Kanata Ontario Canada
K2K 2B7
**Phone:** (613) 591-2100
**Contact:** Mr. E. Martell
Vice President - Quality Assurance and Regulatory Affairs
**Device:** Trade Name: THERAPLAN Plus Version 1.2
Common Name: Radiation Therapy Treatment Planning System
Classification Name: Treatment Planning Computer
**Predicate Devices:**
Theratronics "THERAPLAN PLUS Version 1.0", K954679
Theratronics "THERAPLAN 500", K940237
Nucletron "PLATO", K921991
Radiation Oncology Computer Systems "TPS 1031", K862643
Precision Therapy "Render-Plan", K894722
ADAC "Pinnacle", K926008
**Device Description:**
THERAPLAN Plus Version 1.2 consists principally of application software running under a Windows operating system on a Pentium personal computer. Several THERAPLAN Plus Version 1.2 systems can be networked together for common access to pertinent data. The principal components of the THERAPLAN Plus Version 1.2 are listed below.
**Hardware platform and Operating System:** Pentium PC, Windows NT
**Peripherals and accessories:** Electromagnetic digitizer for manually entering patient anatomy, film scanner for entering anatomy from films, 9 track magnetic tape unit for
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THERAPLAN Plus Version 1.2
510(k) Submission
entering CT and MR images of patient anatomy, laser text printer, 300 dpi, 4 pages per minute minimum, colour printer, 300 dpi.
## Main software features:
*Unit Modelling* of electron and photon beams from accelerators or Cobalt therapy units. Includes entry of wedges, blocks, and multileaf collimators.
*Source Modelling* of point sources, line sources and wires. The operator selects parameters for the sources which are required for treatment planning, such as size, isotope, wall thickness, and half-life.
*Patient Data Acquisition* by means of CT or MR images, a film scanner, or manually entered contours. CT or MR data may be acquired directly for units which support the DICOM 3 image format and communication standard, or by means of a software interface supplied by Theratronics for other units.
*Anatomy Modelling* to prepare the patient data for treatment planning. The portions of the anatomy which are of interest are selected, and contouring is performed of the anatomy exterior, the treatment target volume, and interior organs as needed for treatment planning.
*Brachytherapy Planning* may be performed using sources established during Source Modelling. The location of multiple sources may be specified and sample dose calculations performed. The location of sources may be adjusted for optimization. Time-domain calculations may also be performed based on the pattern of sources and their half-lives.
*External Beam Planning* may be performed using Unit Modelling data and Anatomy Modelling data. Electron and/or photon beams of different treatment units may be applied, and dose calculations performed. The location of the beams may then be adjusted for optimization. Arc therapy treatments can also be modeled.
The THERAPLAN Plus Version 1.2 also includes facilities for the operator to print the treatment plan information for review and to assist with the patient's treatment, and a compensator can be designed to help optimize the radiation pattern of an applied beam.
## Intended Use:
THERAPLAN Plus Version 1.2 is intended to be used as a modelling system to assist health care professionals determine a course of Radiation Therapy to be delivered to a patient. The software is designed to run on a central host computer and support a number of peripherals and accessories. The system can be configured to enter scan data from
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THERAPLAN Plus Version 1.2
510(k) Submission
various types of CT scanners and MR scanners or to manually enter patient contour outlines. THERAPLAN Plus Version 1.2 systems can be networked together for common access to pertinent data.
THERAPLAN Plus Version 1.2 is intended to be used directly by a health care professional capable of assessing the suitability of the output for treatment planning purposes, or to have its output reviewed by someone with these qualifications prior to use.
## Conclusion:
The THERAPLAN Plus Version 1.2 development and validation is in compliance with Theratronics product development procedures. These procedures ensure that system testing and validation demonstrate that the system meets its published specifications, performs as well or better than the predicate products to which is substantially equivalent, and is safe and effective for its intended use.
-- END --
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850
E. S. Martell, Vice President
Quality Assurance and Regulatory Affairs
THERATRONICS International Limited
P.O. Box 13140
Kanata, Ontario
CANADA K2K 2B7
Re: K970236
THERAPLAN Plus Version 1.2 RTP System
Dated: April 29, 1997
Received: April 30, 1997
Regulatory Class: H
21 CFR 892.5050/Procode: 90 IYE
JUL - 9 1997
Dear Mr. Martell:
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 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, 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, 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 the Electronic Product 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) 594-4613. 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" (21 CFR 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/dsmamain.html".
Sincerely yours,
Enclosure
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THERAPLAN Plus Version 1.2
510(k) Submission
# Indications for Use
Page 1 of 1
510(k) Number (if known): K970236
Device Name: THERAPLAN Plus Version 1.2 Radiation Therapy Treatment Planning System
Indications For Use:
THERAPLAN Plus Version 1.2 is intended to be used as a modelling system to assist health care professionals determine a course of Radiation Therapy to be delivered to a patient with cancer. It is designed to be used directly by a health care professional capable of assessing the suitability of the output for treatment planning purposes, or to have its output reviewed by someone with these qualifications prior to use.
(PLEASE DO 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 K970236
Prescription Use ☑ (Per 21 CFR 801.109)
OR
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.
