Registration and Fusion (Basic and Extended) are intended for the simultaneous visualization of multiple medical images of the same patient. The application can assist the user in visually matching and comparing anatomical studies taken at different times or acquired via different imaging modalities (Basic: CT-CT, CT-MR, MR-MR, Extended: CT-PET, MR-PET) as well as assist in making measurements. It is primarily used in the fields of diagnostic radiology, neurology and oncology.
Device Story
Registration and Fusion is a PACS plug-in software for image analysis. It inputs DICOM 3.0 compliant 3-D medical data sets from PET, MR, and CT imaging. The device performs rigid registration, computing an explicit mathematical transformation to align images geometrically. It produces fused outputs via semitransparent overlays or side-by-side displays. Used in radiology, oncology, and neurology departments by trained professionals (radiologists, referring physicians, radiation therapists, physicists, radiographers). The software runs on Agfa Impax PACS workstations. Clinicians use the output to navigate to identical anatomical locations across different studies, facilitating comparison of lesions and treatment follow-up. It also supports SUV and image intensity quantification.
Clinical Evidence
Bench testing only. The device was tested for compatibility with Agfa Impax PACS systems. No clinical data provided.
Technological Characteristics
PACS plug-in software; runs on Windows-based workstations (Impax 5.3/6.3). Processes DICOM 3.0 compliant 3-D image data (CT, MR, PET). Employs rigid registration algorithms and provides SUV/image intensity quantification. Connectivity via PACS network.
Indications for Use
Indicated for simultaneous visualization of multiple medical images of the same patient to assist in visually matching and comparing anatomical studies (CT-CT, CT-MR, MR-MR, CT-PET, MR-PET) and making measurements. Used in diagnostic radiology, neurology, and oncology.
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).
{0}------------------------------------------------
K080013
pg. 1 of 3
# 510(k) Summary
# Agfa Registration and Fusion
Common/Classification Name: Picture Archiving and Communications System (PACS), 21 CFR 892.2050 Proprietary Name: Registration and Fusion
Agfa HealthCare Corporation 10 South Academy Street Greenville, SC 29602-9048
Contact: Tom Holbrook, Prepared: November 9, 2007 Telephone: (519) 746-6210 ext. 3297 Facsimile: (519) 746-3745
JAN 17 2008
### A. LEGALLY MARKETED PREDICATE DEVICES
This is a 510(k) for Agfa's Registration and Fusion software. The predicate device, Mirage 5.5 (K043441), manufactured by Segami Corporation.
The new device is similar in indications and intended use as the predicate device.
#### DEVICE DESCRIPTION B.
Medical Data Registration and Fusion R 1.0 is a PACS plug-in (accessory). It is an image analysis software package that establishes the geometrical relationship between different DICOM 3.0 compliant 3-D medical data sets from PET, MR and CT imaging (registration").
The matched images are displayed (fusion') by either the use of semitransparent overlays or by displaying them side-by-side.
Registration and fusion facilitates the comparison of PET/CT, PET/MRI, CT/CT, MRI/MRI, CT/MRI image data sets for use in:
- The general radiology department for various lesions. ●
- The oncology department for various cancerous lesions. .
Definitions
Image Registration: The alignment of one or more [medical] images to a reference image in order to facilitate geometric comparison. This is a numerical operation that results in the computation of an explicit mathematical transformation between every point in the registered image sets.
mage Fusion: Registration forms the basis of image fusion in the sense that the geometrical alignment of images is a prerequisite. The notion of "fusion" takes this a step further by considering how to visualize the ttent of different images representing the same object [organ, anatomical region, etc.]. Such techniques include the use of overlays, semi-transparent renderings, etc.
{1}------------------------------------------------
K080013
pg-2 of 3
- The neurology department for various lesions. .
The rigid registration used in the application, aims to help the clinician navigate to the same anatomical location in both image sets.
The Medical Data Registration and Fusion software runs on Agfa's PACS workstations (Impax 5.3 and 6.3 workstations).
Typical users of this system are trained professionals, including but not limited to radiologists, referring physicians, radiation therapists, and physicists. Registration may also be used by radiographers for use of the images by radiologists. Registration and fusion has application in general radiology, oncology and neurology.
#### C. INTENDED USE
Registration and Fusion (Basic and Extended) are intended for the simultaneous visualization of multiple medical images of the same patient. The application can assist the user in visually matching and comparing anatomical studies taken at different times or acquired via different imaging modalities (Basic: CT-CT, CT-MR, MR-MR, Extended: CT-PET, MR-PET) as well as assist in making measurements. It is primarily used in the fields of diagnostic radiology, neurology and oncology.
#### SUBSTANTIAL EQUIVALENCE SUMMARY D.
Agfa's Registration and Fusion Software has similar indications and intended use as the legally marketed predicate devices.
The differences do not modify the intended diagnostic or therapeutic effect. It is intended for registering and fusing volumetric medical image data sets for the purpose of diagnosis and treatment follow-up.
Registration and Fusion is used primarily in the fields of general radiology department for various lesions, oncology for various cancerous lesions and neurology for various lesions.
Descriptive characteristics and data provided in this submission are sufficiently precise to assure substantial equivalence.
#### ய் TECHNOLOGICAL CHARACTERISTICS
The technological characteristics are the same in the proposed and predicate device. All devices use similar, commercially available, computers with Windows® operating systems. All operate on DICOM images. All provide rigid registration of CT, MR and PET image data sets
{2}------------------------------------------------
K080013
PG. 3 of 3
and SUV / Image intensity quantification.
## F. TESTING
Registration and Fusion has been tested for compatibility with Agfa's Impax® PACS Systems.
## 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.
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized representation of three wavy lines, which are meant to symbolize the department's mission of promoting health and well-being. The seal is simple and recognizable, and it is used on official documents and materials produced by the HHS.
### Public Health Service
JAN 17 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Agfa HealthCare Corporation % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
Re: K080013
Trade/Device Name: Registration and Fusion Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: January 2, 2007 Received: January 3, 2007
### 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 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.
{4}------------------------------------------------
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 vours.
Nancy C. Brogdon
Nancy C. B rogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
{5}------------------------------------------------
## Indications for Use
510(k) Number (if known): Koloo13
Device Name: Registration and Fusion Indications for Use:
Registration and Fusion (Basic and Extended) is indicated for the simultaneous visualization of multiple medical images of the same patient. The application can assist the user in visually matching and comparing anatomical studies taken at different times or acquired via different imaging modalities (Basic: CT-CT, CT-MR, MR-MR, Extended: CT-PET, MR-PET) as well as assist in making measurements. It is primarily used in the fields of diagnostic radiology, neurology and oncology.
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 Device Evaluation (ODE)
Arrih Whang
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
