IMPAX Next Generation is a Picture Archiving and Communications System (PACS). It provides an interface for the acquisition, digital processing, annotation, review, printing, storage and distribution of multimodality medical images, reports and demographic information for diagnostic purposes within the system and across computer networks. IMPAX Next Generation is intended to be used by trained healthcare professionals including, but not limited to physicians, radiologists, orthopaedic surgeons, cardiologists, mammographers, technologists, and clinicians for diagnosis and treatment planning using DICOM compliant medical images and other healthcare data. MPR, MIP and 3D rendering functionality allows the user to view image data from perspectives different from that in which it was acquired. Other digital image processing functionality such as multi-scale window leveling and image registration can be used to enhance image viewing. As a comprehensive imaging suite, IMPAX Next Generation integrates with servers, archives, Radiology Information Systems (RIS), Hospital Information Systems (HIS), reporting and 3rd party applications for customer specific workflows. Lossy compressed mammography images and digitized film images should not be used for primary image interpretation. Uncompressed or non-lossy compressed "for presentation" images may be used for diagnosis or screening on monitors that are FDA-cleared for mammographic use.
Device Story
IMPAX Next Generation is a comprehensive PACS software suite for clinical environments. It ingests multimodality DICOM medical images, patient demographic data, and reports from hospital networks, RIS, and HIS. The system provides tools for digital image processing (multi-scale window leveling, image registration), visualization (MPR, MIP, 3D rendering), annotation, and report generation. Operated by trained healthcare professionals, the system facilitates diagnostic review and treatment planning. Output is displayed on clinical monitors; clinicians use these visualizations to inform diagnostic decisions and clinical workflows. The system benefits patients by centralizing imaging data and providing advanced viewing tools to support accurate diagnosis and efficient care coordination.
Clinical Evidence
Bench testing only. No clinical trials were performed. Validation testing confirmed that usability, measurements, image processing, and image quality met documented requirements and user expectations.
Technological Characteristics
Software-based PACS running on commercial computer equipment. Supports DICOM (ACR/NEMA PS3.1) standards. Features include multi-scale window leveling, image registration, MPR, MIP, and 3D rendering. Integrates with RIS/HIS and third-party reporting applications. Conforms to ISO 14971 (risk management) and ISO 13485 (quality management).
Indications for Use
Indicated for use by trained healthcare professionals (physicians, radiologists, orthopaedic surgeons, cardiologists, mammographers, technologists, clinicians) for acquisition, display, processing, review, storage, and distribution of DICOM-compliant multimodality medical images, reports, and demographic data for diagnosis and treatment planning. Contraindicated for primary image interpretation using lossy compressed mammography images or digitized film images.
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
IMPAX workstations with MPR, Digital Subtraction and 3D (K022292)
Agfa Orthopedic Software for IMPAX Workstations (K071972)
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K111945
510(K) SUMMARY: IMPAX Next Generation
AUG - 5 2011
Common/Classification Name: Picture Archiving and Communications System 21CFR 892.2050 Proprietary Name: IMPAX Next Generation Agfa HealthCare N.V. Septestraat 27 B-2640 Mortsel Belgium . Contact: Jodi Coleman, Prepared: June 8, 2011 Telephone: (519) 746-6210 Ext. 2485 Facsimile: (519) 746-3745
#### A. LEGALLY MARKETED PREDICATE DEVICES
This is a 510(k) for Agfa's IMPAX Next Generation, which is a picture archiving and communications system. It is substantially equivalent to Agfa's IMPAX workstations with MPR, Digital Subtraction and 3D (K02292), and for orthopedic use to its Agfa Orthopedic Software for IMPAX Workstations (K071972), and for mammography to Agfa's IMPAX MA3000 (K081976).
#### DEVICE DESCRIPTION B.
The new device is largely similar to the predicate devices. It is a comprehensive PACS system that combines the features of IMPAX system with the mammography workstation. This new version includes improvements to the user interface and is designed for ease of deployment and service. It also includes an integrated patient information system, report generation and transcription features.
Principles of operation and technological characteristics of the new and predicate devices are the same. There is no change to the intended use of the device vs. the predicate devices.
#### C. INTENDED USE
IMPAX Next Generation is a Picture Archiving and Communications System (PACS). It provides an interface for the acquisition, digital processing, annotation, review, printing, storage and distribution of multimodality medical images, reports and demographic information for diagnostic purposes within the system and across computer networks. IMPAX Next Generation is intended to be used by trained healthcare professionals including, but not limited to physicians, radiologists, orthopaedic surgeons, cardiologists, mammographers, technologists, and clinicians for diagnosis and treatment planning using DICOM compliant medical images and other healthcare data.
MPR, MIP and 3D rendering functionality allows the user to view image data from perspectives different from that in which it was acquired. Other digital image processing functionality such as multi-scale window leveling and image registration can be used to enhance image viewing.
As a comprehensive imaging suite, IMPAX Next Generation integrates with servers, archives, Radiology Information Systems (RIS), Hospital Information Systems (HIS), reporting and 3rd party applications for customer specific workflows.
Lossy compressed mammography images and digitized film images should not be used for primary image interpretation. Uncompressed or non-lossy compressed "for presentation" images may be used for diagnosis or screening on monitors that are FDA-cleared for mammographic use.
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# SUBSTANTIAL EQUIVALENCE SUMMARY D.
Agfa's IMPAX Next Generation has an Indications for Use statement largely similar to the statements for the predicate devices (K022292, K071972 and K081976). The statements have been combined and simplified. Intended uses are the same. The devices have technological characteristics. Descriptive characteristics and performance data are adequate to ensure equivalence.
Differences in devices do not alter the intended therapeutic/diagnostic effect.
| PRODUCT COMPARISON TABLE | | | | |
|-----------------------------------------|------------------------------------------|-----------------------------------------|-----------------------------------------------|------------------------------------------------|
| | IMPAX Next<br>Generation<br>(NEW DEVICE) | IMPAX General<br>PREDICATE<br>(K022292) | IMPAX<br>Orthopedic<br>PREDICATE<br>(K071972) | IMPAX<br>Mammography<br>PREDICATE<br>(K081976) |
| Communications | DICOM | DICOM | DICOM | DICOM |
| Orthopedic Use,<br>Treatment planning | √ | | √ | |
| Mammographic Use | √ | | | √ |
| Operating system | Windows Vista | Windows 2000 | Windows 7 | Windows 7 |
| Network Access | √ | √ | √ | √ |
| Multiple displays | √ | √ | √ | √ |
| Image Export | BMP, JPG,<br>TIF, AVI | BMP, JPG,<br>TIF, AVI | BMP, JPG,<br>TIF, AVI | BMP, JPG,<br>TIF, AVI |
| Window Level | √ | √ | √ | √ |
| Multi-Scale Window<br>Level | √ | √ | √ | √ |
| Pan/Zoom | √ | √ | √ | √ |
| Rotate | √ | √ | √ | √ |
| Calibrate/Measure | √ | √ | √ | √ |
| Annotate | √ | √ | √ | √ |
| MIP, MPR | √ | | | |
| Musica Image<br>Reprocessing | √ | | | |
| 3D Rendering | √ | √ | √ | √ |
| Patient Information<br>System (HIS/RIS) | √ | | | |
| Dictation & Speech | √ | | | |
Table 1: Device Predicate Comparison
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## TECHNOLOGICAL CHARACTERISTICS E.
Agfa's IMPAX Next Generation is a PACS device for the acquisition, display, digital processing, annotation, review, printing, storage and distribution of multimodality medical images, reports and demographic information for diagnostic and treatment planning purposes.
It is a software device running on commercially available computer equipment that allows users to view and modify DICOM compliant medical images and patient information.
## F. TESTING
The new device includes proven technology from the Agfa predicates which has been tested to demonstrate its suitability for digital mammography.
The device has been designed and manufactured to conform to the following standards:
- ACR/NEMA PS3.1 3.18 Digital Imaging and Communications in Medicine (DICOM) ●
- ISO 14971 Application of Risk Management to Medical Devices .
- ISO 13485 Medical Devices Quality Management Systems Requirements For Regulatory . purposes
IMPAX Next Generation has been tested and shown to conform to documented requirements. Validation testing confirms that usability, measurements, image processing and image quality meet user expectations.
No clinical trials were performed in the development of the device.
### G. CONCLUSIONS
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 for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring. MD 20993-0002
Agfa I-lealthCare N.V. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25" Street NW BUFFALO MN 55313
AUG - 5 2011
Re: K111945
Trade/Device Name: IMPAX Next Generation Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: July 7, 2011 Received: July 8, 2011
Dear Mr. Job:
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 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 comply with 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 Viro 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.
Mary Pastel
Mary S. Pastel, Sc.D. 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): 长川 (1945
Device Name: IMPAX Next Generation
Indications for Use:
Agfa's IMPAX Next Generation is a Picture Archiving and Communications System (PACS). It provides an interface for the acquisition, display, digital processing, annotation, review, printing, storage and distribution of multimodality medical images, reports and demographic information for diagnostic purposes within the system and across computer networks. IMPAX Next Generation is intended to be used by trained healthcare professionals including, but not limited to physicians, radiologists, orthopaedic surgeons, cardiologists, mammographers, technologists, and clinicians for diagnosis and treatment planning using DICOM compliant medical images and other healthcare data.
MPR, MIP and 3D rendering functionality allows the user to view image data from perspectives different from that in which it was acquired. Other digital image processing functionality such as multi-scale window leveling and image registration can be used to enhance image viewing.
As a comprehensive imaging suite, IMPAX Next Generation integrates with servers, archives, Radiology Information Systems (RIS), Hospital Information Systems (HIS), reporting and 3rd party applications for customer specific workflows.
Lossy compressed mammography images and digitized film images should not be used for primary image interpretation. Uncompressed or non-lossy compressed "for presentation" images may be used for diagnosis or screening on monitors that are FDA-cleared for mammographic use.
Prescription Use X (Part 21 CFR 801 Subpart D) 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)
AND/OR
Mary S. Fratel
Division Sign-Off Office of In Vitro Diagnostic Device
ર I O(K
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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.
