K040028 · R2 Technology, Inc. · LLZ · Jan 22, 2004 · Radiology
Device Facts
Record ID
K040028
Device Name
CA-1500
Applicant
R2 Technology, Inc.
Product Code
LLZ · Radiology
Decision Date
Jan 22, 2004
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 892.2050
Device Class
Class 2
Attributes
Software as a Medical Device, 3rd-Party Reviewed
Indications for Use
The Comprehensive Chest Analysis Tools (C-CAT) package is intended to provide the radiologist the ability to visualize thoracic CT series with enhanced imaging tools such as MPR and MIP; analyze, automatically/manually align and compare simultaneously presented current and previous thoracic CT images and selected "candidate" regions of interest (ROIs).
Device Story
C-CAT software assists radiologists in thoracic CT analysis; inputs include current and prior CT image series. Features include Multi-Planar Reformat (MPR) and Sliding Maximum Image Projection (MIP) for visualization; automated/manual image registration; and comparative analysis of ROIs. Software calculates volumetric growth and doubling time of candidate lesions. Used in clinical settings on ImageChecker CT Workstations or compatible CT workstations. Radiologists review software-generated comparative reports to assess lesion progression, new lesion development, and doubling time. Output aids clinical decision-making regarding patient management and lesion characterization.
Clinical Evidence
Bench testing only. The device underwent design verification tests to ensure conformance with specifications.
Technological Characteristics
Software-based thoracic CT analysis tool. Features MPR and MIP visualization, image registration, and volumetric measurement algorithms. Designed for integration with ImageChecker CT Workstation or compatible CT workstations. No specific hardware materials or sterilization methods applicable as it is a software package.
Indications for Use
Indicated for radiologists to view, analyze, register, and compare current and prior thoracic CT series. Assists in calculating volume change and doubling time of segmented candidate thoracic abnormalities (e.g., pulmonary/pleural nodules and lesions) to aid in characterization, classification, and patient management decisions.
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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JAN 2 2 2004
Image /page/0/Picture/1 description: The image shows a stylized logo or symbol that appears to be a combination of the letters 'R' and the number '2'. The 'R' is drawn in a bold, somewhat ornate font, with serifs at the top and bottom. The number '2' is stylized to curve around the 'R', and there is a small circle or dot to the right of the '2', possibly serving as a decorative element or punctuation mark. The overall design is simple and monochromatic.
1195 W. Fremont Avenue Sunnyvale, CA 94087 3832 408.481.5600 p 408,481.5601 /
## 510(k) Summary of Safety and Effectiveness Prepared October 20th 2003
| Submitted by: | R2 Technology, Inc.<br>1195 W. Fremont Avenue<br>Sunnyvale, CA 94087 |
|-----------------|----------------------------------------------------------------------|
| Contact Person: | Kathy O'Shaughnessy<br>Vice President, Regulatory Affairs |
| Product Name: | CA-1500 |
| Common Name: | Comprehensive Chest Analysis Tools (C-CAT) |
| Classification: | LLZ, Class II; CFR 21 892.2050 |
Predicate Devices:
| Product | Company | 510(k) Number | Product<br>Classification |
|---------------------------------|-------------------------------------|---------------|---------------------------|
| ImageChecker CT<br>Workstation | R2 Technology Inc. | K023003 | LLZ, Class II |
| Advanced Lung<br>Analysis-1 | General Electric<br>Medical Systems | K013381 | JAK, Class II |
| LungCARE CT<br>Software Package | Siemens Medical<br>Solutions | K022013 | JAK, Class II |
# Device Description:
The C-CAT software is dedicated to assist the radiologist in assessing multiple CT case studies as well as any selected abnormal thoracic regions of interest (ROI's), such as pulmonary lesions, nodules, etc. It enables:
- a) a detailed visualization and analysis of the CT slices using tools such as Multi-Planar Reformat and Sliding Maximum Image Projection;
- b) a comparative analysis of the aligned, simultaneously presented current and previous CT images with findings and selected ROIs with their size (volumetric and diameter) measurement displayed for assessment of volume change and doubling time; and
w.r2tech.com
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- c) review of software-generated comparative reports that present information such as development of new lesions, prior lesion's progression and doubling time. This software tools package is designed for use with the ImageChecker CT Workstation (K023003, cleared 11/20/02) and other CT workstations that utilize the ImageChecker CT Workstation software tools.
### Summary of Intended Use:
The Comprehensive Chest Analysis Tools (C-CAT) package is intended to provide the radiologist the ability to visualize thoracic CT series with enhanced imaging tools such as MPR and MIP; analyze, automatically/manually align and compare simultaneously presented current and previous thoracic CT images and selected "candidate" regions of interest (ROIs).
## Comparison with Predicate Devices:
#### Hardware Platform Predicate:
R2 Technology's Comprehensive Chest Analysis Tools (C-CAT) package will reside in the ImageChecker CT Workstation hardware or any cleared CT workstation that has the ImageChecker CT Workstation software. The ImageChecker CT Workstation is the predicate for the hardware platform for this product.
#### Software Component Predicates:
R2 Technology's Comprehensive Chest Analysis Tools (C-CAT) package, GE's Advanced Lung Analysis (ALA-1) software package and Siemens LungCARE CT software package enable radiologists to view, analyze, register and compare current and prior thoracic CT series. These software packages allow the radiologist to examine segmented candidate chest lesions found in the CT case studies. These software packages also enable the radiologist to determine volumetric growth and doubling time of these lesions over time. Thus, their functional features are substantially equivalent.
# Studies:
The Comprehensive Chest Analysis Tools package will undergo design verification tests for conformance with specifications.
# Conclusion:
The Comprchensive Chest Analysis Tools package has the same intended use as the two software predicate devices identified in this section. Any technological differences in the Comprehensive Chest Analysis Tools package and the predicate devices do not raise any new questions regarding safety or effectiveness. Thus, R2 Technology's Comprehensive Chest Analysis Tools package is substantially equivalent to the predicate devices,
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 2 2004
R2 Technology, Inc. % Ms. Denise Leung Klinker Reviewer Underwriters Laboratories, Inc. 1655 Scott Boulevard SANTA CLARA CA 95050-4169 Re: K040028 Trade/Device Name: CA-1500, Comprehensive Chest Analysis tools (C-CAT) Package Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II
Product Code: 90 LLZ Dated: January 6, 2003 Received: January 8, 2003
Dear Ms. Klinker:
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 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 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 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) 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), please contact the Office of Compliance at one of the following numbers, based 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 Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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,
Nancy C. Brigdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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R2 Technology Comprehensive Chest Analysis Tools 510(k) Premarket Notification Oct. 20", 2003
K040028
## Indications for Use:
The Comprehensive Chest Analysis Tools (C-CAT) package consists of software that enables radiologists to view, analyze, register and compare new and previous series of thoracic CT images. The software package assists the radiologists by calculating volume change and doubling time of selected segmented candidate thoracic abnormalities, such as pulmonary and pleural nodules and lesions, found on these images.
The software is designed to assist the radiologists in characterization and classification of these suspicious candidate thoracic abnormalities in terms of size, dimension, shape and position and thus aid in the patient management care decision process.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use: x (Pcr 21 CFR 801.109)
Over-The-Counter: -OR-
David des. Seppanen
---
(Division Sign Off)
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 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.
