K073272 · Three Palm Software, LLC · LLZ · Dec 11, 2007 · Radiology
Device Facts
Record ID
K073272
Device Name
WORKSTATIONONE BREAST IMAGING WORKSTATION
Applicant
Three Palm Software, LLC
Product Code
LLZ · Radiology
Decision Date
Dec 11, 2007
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 892.2050
Device Class
Class 2
Attributes
Software as a Medical Device
Indications for Use
The WorkstationOne™ Breast Imaging Workstation is intended for use with a regionally approved digital mammography system. The workstation displays images from multiple modalities, which include X-ray mammography MG, breast US and breast MRI. The workstation allows selection, display, manipulation, quantification, markup, print composition and media exchange of breast images. Here, quantification refers to measurements (such as area and distance) within a region of interest that the radiologist manually draws on the images. Similarly, markup refers to graphics that are manually drawn by the radiologist to indicate a region of interest. Note that the region of interest is not automatically generated by the computer. The WorkstationOne™ Breast Imaging Workstation is intended for softcopy reading and interpretation of digital mammography images by Radiologists. The WorkstationOne™ Breast Imaging Workstation when used for interpretation of images acquired using a FFDM image acquisition system shall display the images only on FDA-cleared high-resolution monitors. The images used for primary diagnostic reading must be in a lossless format, unless lossy formats are approved for use in digital mammography.
Device Story
WorkstationOne™ is a diagnostic breast imaging workstation software; operates on off-the-shelf general-purpose computers with high-resolution grayscale monitors and a color monitor. Inputs: digital breast images (MG, US, MRI) and CAD reports from PACS or modalities via DICOM. Function: displays, manipulates, and manages images for radiologist interpretation; supports IHE integration profiles (MAMMO, RWP). Output: visual display of images/overlays for primary diagnostic reading; optional reporting system interface. Used in clinical settings by radiologists. Benefits: facilitates efficient softcopy reading, interpretation, and workflow management for breast imaging studies.
Clinical Evidence
Bench testing only. Software testing procedure with pass/fail criteria was conducted to ensure the product meets specified requirements. No clinical data provided.
Technological Characteristics
Software-based workstation; runs on off-the-shelf general-purpose computers. Hardware includes high-resolution grayscale monitors and color monitor for UI. Connectivity via DICOM; supports IHE integration profiles (MAMMO, RWP). Manual quantification and markup tools provided; no automated region-of-interest generation.
Indications for Use
Indicated for softcopy reading and interpretation of digital mammography images (MG), breast ultrasound (US), and breast MRI by radiologists. Supports manual quantification and markup of regions of interest.
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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K073272
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Three Palm Software, LLC
### 5. 510(k) Summary (as required by section 807.92(c))
#### 5.1. 510(k) Submitter
510(k) owner's name: Three Palm Software, LLC Address: 367 Penn Way, Los Gatos, CA 95032 USA Phone: 408-356-3240 Name of contact person: Heidi Daoxian Zhang Date the summary was prepared: November 19, 2007
DEC 1 1 2007
#### 5.2. Device Name
Trade name: WorkstationOne™ Breast Imaging Workstation
Common name: Picture archiving and communications system
Classification name: System, Image Processing, Radiological (21 CFR 892.2050 Product Code LLZ)
#### 5.3. Predicate Devices
WorkstationOne™ Breast Imaging Workstation is substantially equivalent to the devices listed below:
| Trade Name | Manufacturer | 510(k) Number |
|-----------------------|-------------------------------------|---------------|
| Seno Advantage | General Electric Medical<br>Systems | K033400 |
| Cedara<br>I-ReadMammo | Cedara Software Corp. | K040468 |
| Secta Workstation | Sectra Imtec AB | K063093 |
#### 5.4. Device Description
The WorkstationOne™ is a diagnostic breast imaging workstation which consists of a software system that obtains breast imaging screening or diagnosis exams from PACS or Modalities; displays and manipulates the images for radiologists to perform interpretation task. The workstation also supports media exchange and film printing. Optionally, the workstation can interface with a reporting system to generate an interpretation report.
The enterprise workflow of the workstation follows IHE integration profiles, specifically, MAMMO (Mammography Image Profile) and RWP (Reporting Workflow Profile). The workstation can be configured to use mammographic specific hanging protocol and reading workflow. The workstation obtains the source images and CAD reports either as the recipient of the push of that data, or by querying and retrieving them from a PACS archive. In both models, DICOM is used. The images can only be the lossless compressed or non-compressed DICOM images.
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Three Palm Software, LLC
The WorkstationOne™ is a software system that can be installed on an off-the-shelf general-purpose computer with one or two aray-scale high-resolution monitors and one color monitor. The high-resolution monitors are used to display digital mammography images and associated overlays for the purpose of primary interpretation by radiologists. The color monitor is used for selecting studies, displaying color images, navigating workflow, and other user interface elements. Optionally, a dedicated keypad or touchpad is included for ergonomic reasons.
## 5.5. Indications for Use
The WorkstationOne™ Breast Imaging Workstation is intended for use with a regionally approved digital mammography system. The workstation displays images from multiple modalities, which include X-ray mammography MG, breast US and breast MRI. The workstation allows selection, display, manipulation, quantification, markup, print composition and media exchange of breast images. Here, quantification refers to measurements (such as area and distance) within a region of interest that the radiologist manually draws on the images. Similarly, markup refers to graphics that are manually drawn by the radiologist to indicate a region of interest. Note that the region of interest is not automatically generated by the computer.
The WorkstationOne™ Breast Imaging Workstation is intended for softcopy reading and interpretation of digital mammography images by Radiologists.
The WorkstationOne™ Breast Imaging Workstation when used for interpretation of images acquired using a FFDM image acquisition system shall display the images only on FDA-cleared high-resolution monitors. The images used for primary diagnostic reading must be in a lossless format, unless lossy formats are approved for use in digital mammography.
## 5.6. Technological Characteristics Comparison
WorkstationOne™ Breast Imaging Workstation has the similar technological characteristics to the equivalent devices as all support radiology workflow integration, obtaining, displaying, and manipulating of MG, US or MR images. Both the WorkstationOne™ Breast Imaging Workstation and the Sectra Workstation allow displaying of CAD reports.
## 5.7. Non-clinical Test
The potential hazards have been studied and controlled by a Risk Management Plan. The software testing procedure has been developed. The procedure with pass/fail criteria has been run to ensure that the product meets all the specified requirements.
## 5.8. Conclusions
The materials provided in this 510(k) submission have demonstrated the device is as safe, as effective, and performs as well as the predicate devices.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 1 2007
Ms. Heidi Daoxian Zhang Vice President, Clinical Affairs Three Palm Software, LLC 367 Penn Way LOS GATOS CA 95032
Re: K073272
Trade/Device Name: WorkstationOne™ Breast Imaging Workstation Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: November 19, 2007 Received: November 21, 2007
Dear Ms. Zhang:
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.
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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.
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.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
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# 4. Indications for Use Statement
510(k) Number (if known): K073272
Device Name: WorkstationOne™ Breast Imaging Workstation
#### Indications for Use:
The WorkstationOne™ Breast Imaging Workstation is intended for use with a regionally approved digital mammography system. The workstation displays images from multiple modalities, which include X-ray mammography MG, breast US and breast MRI. The workstation allows selection, display, manipulation, quantification, markup, print composition and media exchange of breast images. Here, quantification refers to measurements (such as area and distance) within a region of interest that the radiologist manually draws on the images. Similarly, markup refers to graphics that are manually drawn by the radiologist to indicate a region of interest. Note that the region of interest is not automatically generated by the computer.
The WorkstationOne™ Breast Imaging Workstation is intended for softcopy reading and interpretation of digital mammography images by Radiologists.
The WorkstationOne™ Breast Imaging Workstation when used for interpretation of images acquired using a FFDM image acquisition system shall display the images only on FDA-cleared high-resolution monitors. The images used for primary diagnostic reading must be in a lossless format, unless lossy formats are approved for use in digital mammography.
Prescription Use マ (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use
(21 CER 801 Subnart C (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
hontmkhang
(Division Division of Reproductive, Abdominal an Page 6 of 48 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.
