Impax Volume Viewing software is a visualization package for PACS workstations. It is intended to support radiographer, medical imaging technician, radiologist and referring physician in the reading, analysis and diagnosis of DICOM compliant volumetric medical datasets. The software is a general purpose digital medical image processing tool, with optional functionality to facilitate visualization and measurement of vessel features. Other optional functionality is intended for the registration of anatomical (CT) on functional volumerric image data (MR) to facilitate the comparison of various lesions. Volume and distance measurements are intended for evaluation and quantification of tumor measurements, and other analysis and evaluation of both hard and soft tissues. The software also supports interactive segmentation of a region of interest (ROI).
Device Story
Impax Volume Viewing is a software accessory for PACS workstations used by radiologists, technicians, and physicians. It inputs DICOM-compliant volumetric medical datasets (e.g., CT, MR). The software provides tools for 3D volume rendering, multi-planar reconstruction (MPR), curved planar reformation (CPR), and intensity projections (MIP/MiniP/AveIP). It enables automatic or manual registration/fusion of multi-modality datasets, interactive segmentation of regions of interest (ROI), and vessel analysis. Outputs include visualized images, color maps, subtraction views, and quantitative measurements (volume/distance) for tumor evaluation and tissue analysis. Clinicians use these outputs to assist in reading, analysis, and diagnosis of medical images. The device facilitates clinical decision-making by providing enhanced visualization and quantification of anatomical and functional data.
Clinical Evidence
No clinical trials were performed. Substantial equivalence is supported by verification and validation testing confirming the device meets performance, measurement, and usability requirements.
Technological Characteristics
Software accessory for PACS. Features: 3D volume rendering, MPR, CPR, MIP, fusion/subtraction, vessel segmentation, and measurement tools. Connectivity: DICOM-compliant. Standards: EN12435:2006, ISO 14971:2007, ISO 13485:2003. Operates on PACS workstations.
Indications for Use
Indicated for use by radiographers, medical imaging technicians, radiologists, and referring physicians to read, analyze, and diagnose DICOM-compliant volumetric medical datasets. Supports visualization/measurement of vessel features, registration of anatomical (CT) and functional (MR) data for lesion comparison, tumor quantification, and soft/hard tissue analysis.
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).
Voxar 3D Enterprise with ColonMetrix and PET/CT Perfusion (K070831)
Submission Summary (Full Text)
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K 111638
## JUN 2 4 2011
## 510(K) SUMMARY: IMPAX VOLUME VIEWING
Common/Classification Name: Picture Archiving and Communications System 21 CFR 892.2050 Proprietary Name: Impax Volume Viewing Agfa HealthCare N.V. Septestraat 27 B-2640 Mortsel Belgium Contact: Koen Cobbaert, Prepared: May 6, 2011 Telephone: 32 3 444 7539
#### LEGALLY MARKETED PREDICATE DEVICES A.
This is a 510(k) for Agfa's Impax Volume Viewing software, which is an accessory to its Impax picture archiving and communications systems. It is substantially equivalent to Agfa's Registration and Fusion software (K080013) in the majority of its functionality and to the Voxar 3D Enterprise with ColonMetrix and PET/CT Perfusion (K070831) with respect to its vessel viewing functionality.
#### B. DEVICE DESCRIPTION
The new device is similar to the predicate devices. All are PACS system accessories that allow the user to view and manipulate three dimensional image data sets.
Principles of operation and technological characteristics of the new and predicate devices are the same. The intended uses of the new and predicate devices are also the same.
#### c. INTENDED USE
Impax Volume Viewing software is a visualization package for PACS workstations. It is intended to support radiographer, medical imaging technician, radiologist and referring physician in the reading, analysis and diagnosis of DICOM compliant volumetric medical datasets. The software is a general purpose digital medical image processing tool, with optional functionality to facilitate visualization and measurement of vessel features.
Other optional functionality is intended for the registration of anatomical (CT) on functional volumerric image data (MR) to facilitate the comparison of various lesions. Volume and distance measurements are intended for evaluation and quantification of tumor measurements, and other analysis and evaluation of both hard and soft tissues. The software also supports interactive segmentation of a region of interest (ROI).
#### D. SUBSTANTIAL EQUIVALENCE SUMMARY
Agfa's Impax Volume Viewing has an Indications For Use Statement largely similar to the statements for the two predicate. Intended uses are the same. As software accessories to PACS systems, the predicate and new devices have the same technological characteristics. Software is used to identify characteristic patterns within 3D image data which the user can then view and manipulate. Descriptive characteristics and performance data are adequate to ensure equivalence.
Differences in the new device and the predicates do not alter their intended therapeutic/diagnostic effects.
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# Agfa HealthCare NV
Premarket Notification: Impax Volume Viewing
l
| PRODUCT COMPARISON TABLE | | | |
|----------------------------------------------------|-----------------------------------------|---------------------------------------------------------|----------------------------------------------------------------------------------------|
| | Impax<br>Volume Viewing<br>(NEW DEVICE) | Impax<br>Registration and Fusion<br>(PREDICATE K080013) | Voxar 3D Enterprise<br>with ColonMetrix and<br>PET/CT Perfusion<br>(PREDICATE K070831) |
| 3D Volume rendering | √ | √ | √ |
| MPR CPR | √ | MPR | √ |
| MIP MiniP AveIP | √ | MIP | √ |
| Fusion and subtraction views | √ | √ | - |
| Can load and register two data sets for comparison | √ | √ | - |
| Multi-modality (CT and MR) image registration | √ | √ | - |
| Vessel analysis | √ | - | √ |
| Manual slice by slice volume-of-interest | √ | √ | - |
| DICOM and AVI movie generation | √ | √ | √ |
| Reformat to a new dataset | √ | √ | √ |
| Color maps | √ | √ | √ |
| Annotations and measurements | √ | √ | √ |
| Automatic table top removal | √ | √ | √ |
| User Interface | Impax | Impax | Voxar |
·
5 - 4
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#### TECHNOLOGICAL CHARACTERISTICS C.
Impax Volume Viewing is a software accessory to Agfa's Impax Picture Archiving and Communications system.
It is a tool for conveniently viewing and manipulating cross-sectional image series' for display in any orientation and slice thickness. A second series can be registered or fused to the first automatically, manually or with user defined landmarks. Segmentation of blood vessels and airfilled structures facilitate the visualization of vessel features. Color maps, subtraction views, multiple screen layouts and tools for measurement, calculations and annotations are provided.
#### F. TESTING
Verification and validation testing confirm the device meets performance, measurement and usability requirements. No clinical trials were performed in the development of the device.
The new device and Agfa's management systems conform to the following standards:
- EN12435:2006 Health Informatics Expression of Results of Measurements in Health ● Sciences
- . ISO 14971:2007 - Application of Risk Management to Medical Devices
- ISO 13485:2003 Medical Devices Quality Management Systems Requirements For . Regulatory Purposes
#### CONCLUSIONS G.
This 510(k) 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.
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Image /page/3/Picture/0 description: The image shows the logo of the U.S. Department of Health and Human Services. The logo consists of a stylized human figure with three arms, enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around it. The text "DEPARTMENT" is written in bold, sans-serif font to the right of the logo.
## DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
AGFA Healthcare N.V. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO NY 55313
AUG 2 3 2013
Re: K111638
Trade/Device Name: Impax Volume Viewing Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: June 10, 2011 Received: June 13, 2011
Dear Mr. Job:
This letter corrects our substantially equivalent letter of June 24, 2011.
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 I va may a 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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 or mr) 2 vith all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Janine M. Morris
Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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## Indications for Use
510(k) Number (if known):
Device Name: Impax Volume Viewing
### Indications for Use:
Impax Volume Viewing is a visualization package for PACS workstations. It is intended to support radiographer, medical imaging technician, radiologist and referring physician in the reading, analysis and diagnosis of DICOM compliant volumetric medical datasets. The software is intended as a general purpose digital medical image processing tool, with optionality to facilitate visualization and measurement of vessel features.
Other optional functionality is intended for the registration of anatomical (CT) on functional volumetric image data (MR) to facilitate the comparison of various lesions. Volume and distance measurements are intended for evaluation and quantification of tumor measurements, and other analysis and evaluation of both hard and soft tissues. The software also supports interactive segmentation of a region of interest (ROI).
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Mary S Patil
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K111638
Page 1 of
FDA CDRH DMC
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.
