IMPAX® Workstations with MPR, Digital Subtraction and 3D options are intended for use in the acquisition, display, digital processing, review, transfer, storage, archiving and printing of medical images and patient demographic information. They are indicated for use by the physician to aid in diagnosis, and by medical professionals whenever they would require or desire access to medical images and patient demographic information. MPR and 3D functions allow the user to view 3D image data from perspectives different from that in which it was acquired. Digital subtraction allows a user viewing time series studies to remove densities not enhanced by a contrast medium, highlighting vascular structures.
Device Story
IMPAX Workstations are medical image management systems used in clinical settings (diagnostic, cardiology, orthopedics, review, and quality control). The device accepts medical images and patient demographic data. It provides multi-planar reconstruction (MPR), 3D visualization, and digital subtraction capabilities. MPR and 3D functions allow users to view 3D image data from perspectives different from the acquisition plane. Digital subtraction removes non-contrast-enhanced densities from time-series studies to highlight vascular structures. Physicians and medical professionals operate the system to review, process, and archive images. The output, displayed on the workstation, assists clinicians in diagnostic decision-making by providing enhanced visualization of anatomical and vascular structures.
Clinical Evidence
Bench testing only. Testing included unit tests, system tests, integration tests, and field/beta tests conducted by the manufacturer and software developer to validate performance under simulated and actual use conditions.
Technological Characteristics
Workstations operate on commercially available computer systems. Features include MPR, 3D rendering, and digital subtraction. Connectivity is provided via DICOM standard compliance. Software-based image processing.
Indications for Use
Indicated for use by physicians to aid in diagnosis and by medical professionals requiring access to medical images and patient demographic information.
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).
Predicate Devices
Philips EasyVision workstations with Endo-3D option (K973983)
Philips EasyVision workstations with Quantitative Analysis option (K971965)
Submission Summary (Full Text)
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| PMN | |
|--------------|--|
| K022292 | |
| NOT DEFINED | |
| NOT DEFINED | |
| 510K Summary | |
| 12-SEP-2002 | |
| 001 | |
| | |
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SEP 1 2 2002
### 510(k) Summary
### IMPAX® Workstations with MPR, Digital Subtraction and 3D options
Common/Classifications Name: Picture Archiving and Communications System, 21 CFR 892.2050
Agfa Corporation 10 South Academy Street Greenville SC 29602-9048 Contact: Jeff Jedlicka, Prepared July 10, 2002
#### Legally Marketed Predicate Devices A.
The legally marketed predicate devices are the Philips EasyVision workstations with Endo-3D option (cleared on January 8, 1998 as K973983) and Quantitative Analysis option (cleared on January 30, 1998 as K971965).
#### Device Description в.
The predicate devices and IMPAX® Workstations with MPR, Digital Subtraction and 3D options are medical image management devices.
Workstation configurations include a general purpose diagnostic workstation (DS3000) and analogous versions for cardiologists (Cardio3000) and orthopedists (OT3000). A review workstation (CS5000) is available for use by persons other than the interpreting physicians; and a quality control workstation (QC3000) provides administrative functions and the ability to view and correct improper operator entries.
The multi-planar reconstruction, digital subtraction and 3D features described in this notification will be offered as options, either separately or combined on multiple workstation configurations.
#### C. Intended Use
IMPAX® Workstations with MPR, Digital Subtraction and 3D options are intended for use in the acquisition, display, digital processing, review, transfer, storage, archiving and printing of medical images and patient demographic information.
They are indicated for use by the physician to aid in diagnosis, and by medical professionals whenever they would require or desire access to medical images and patient demographic information.
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MPR and 3D functions allow the user to view 3D image data from perspectives different from that in which it was acquired. Digital subtraction allows a user viewing time series studies to remove densities not enhanced by a contrast medium, highlighting vascular structures.
### Substantial Equivalence Summary D.
Impax® Workstations with MPR, Digital Subtraction and 3D options have the same intended use as the predicate devices. The differences in indications statements do not alter the intended diagnostic effect. Both the IMPAX® Workstations with MPR, Digital Subtraction and 3D, and the predicate devices are intended for use by the physician to assist in diagnosis.
The image manipulation tools are comparable. Each tool gives the user an ability to view image data from a perspective different from the one in which it was acquired.
Both IMPAX® workstations and Philips EasyVision workstation (Endo-3D, K973983) allow the user to choose optional planes from which to view three dimensional image data, and to create and view three dimensional representations.
Both IMPAX® workstations and Philips EasyVision workstation (Quantitative Analysis, K971965) allow the user viewing time series studies to remove image densities not enhanced by a contrast medium.
#### E. Technological Characteristics
The workstations have the same technological characteristics. All are of similar design and constructed of similar materials.
All products operate on commercially available computer systems.
All comply with the DICOM standard for communications with other imaging system components.
#### ட் Testing
IMPAX Workstations with MPR, Digital Subtraction and 3D options are subject to testing according to established procedures by both Agfa and the software developer. No product will be released for distribution or sale until all required tests and validation activities have been successfully combleted.
Tests are conducted according to documented test plans. Records of test results are maintained.
The following types of tests are conducted:
Unit tests - Tests of a single component or module, usually conducted by or
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under the direction of development personnel.
System tests - Tests of multiple components or modules, up to and including the entire system. System tests are conducted by persons independent of the development personnel.
Integration tests – Tests by Agfa of system performance under simulated use conditions.
Field tests - Tests of a complete system in a user setting, but under the direct control of Agfa.
Beta tests - Tests of a system in a user setting, but without the immediate or direct control of Agfa.
#### G. Conclusions
This premarket notification has demonstrated Substantial Equivalence as defined and understood in the Federal Food Drug and Cosmetic Act and various guidance documents issued by the Center for Devices and Radiological Health.
ﺑﺘﺼﺪ
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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES" written around the perimeter. Inside the circle is an abstract image of an eagle's head.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 2 2002
Re: K022292
Agfa Corporation HealthCare Division % Mr. David D. Ledwig Principal Consultant Practical Compliance, LLC P.O. Box 1927 BREVARD NC 28712
Trade/Device Name: IMPAX® workstations with MPR, Digital Subtraction and 3D Options Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II
Product Code: 90 LLZ Dated: July 10, 2002 Received: July 15, 2002
Dear Mr. Ledwig:
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 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 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 this 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" (21 CFR Part 807.97). 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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### STATEMENT OF INDICATIONS FOR USE
510(k) Number (if known):
Device Name: IMPAX® Workstations with MPR, Digital Subtraction and 3D options
Indications For Use:
IMPAX® Workstations with MPR, Digital Subtraction and 3D options are intended for use in the acquisition, display, digital processing, review, transfer, storage, archiving and printing of medical images and patient demographic information.
They are indicated for use by the physician to aid in diagnosis, and by medical professionals whenever they would require or desire access to medical images and patient demographic information.
MPR and 3D functions allow the user to view 3D image data from perspectives different from that in which it was acquired. Digital subtraction allows a user viewing time series studies to remove densities not enhanced by a contrast medium, highlighting vascular structures.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE (F NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
| 510(k) Number | K022292 |
|---------------|---------|
|---------------|---------|
| Prescription Use | OR | Over-The-Counter Use |
|----------------------|----|----------------------|
| (Per 21 CFR 801.109) | | |
E3 - 1
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.
