K120636 · Fujifilm Medical System U.S.A., Inc. · LLZ · Jul 5, 2012 · Radiology
Device Facts
Record ID
K120636
Device Name
SYNAPSE 3D CARDIAC TOOLS
Applicant
Fujifilm Medical System U.S.A., Inc.
Product Code
LLZ · Radiology
Decision Date
Jul 5, 2012
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 892.2050
Device Class
Class 2
Attributes
Software as a Medical Device
Indications for Use
Synapse 3D Cardiac Tools is medical imaging software used with Synapse 3D Base Tools that is intended to provide trained medical professionals with tools to aid them in reading, interpreting, reporting, and treatment planning. Synapse 3D Cardiac Tools accepts DICOM compliant medical images acquired from a variety of imaging devices including, CT, MR, NM, and XA. This product is not intended for use with or for the primary diagnostic interpretation of Mammography images. Addition to the tools in Synapse 3D Base Tools, Synapse 3D Cardiac Tools provides the tools for specific clinical applications which provide targeted workflows, custom UI, targeted measurements and reporting functions including: > Functional cardiac analysis for CT left ventriculography images: which is intended to evaluate the functional characteristics of heart > Functional cardiac analysis for non-contrast MR heart images: which is intended to evaluate the functional characteristics of heart > Coronary artery analysis for CT coronary arteriography images: which is intended for the qualitative and quantitative analysis of coronary arteries > Coronary artery analysis for MR heart images: which is intended for the qualitative and quantitative analysis of coronary arteries > Calcium scoring for non-contrast CT heart images: which is intended for non-invasive identification and quantification of calcified atherosclerotic plaques in the coronary arteries using tomographic medical image data and clinically accepted calcium scoring algorithms > Cardiac Fusion: which is intended to analyze cardiac anatomy and pathology with a fused image of functional data (e.g. NM image, Bulls eye) and anatomical data.
Device Story
Synapse 3D Cardiac Tools (V3.0) is medical image processing software; operates in conjunction with Synapse 3D Base Tools. Inputs: DICOM-compliant CT, MR, NM, and XA images. Functionality: cardiac function evaluation (left ventricle/wall boundary extraction, ejection fraction/volume calculations); coronary artery path extraction/evaluation; calcium scoring (Agatston method); cardiac fusion (functional/anatomical data overlay). Used by trained medical professionals in clinical settings for treatment planning and reporting. Output: processed images, quantitative measurements, and reports. Assists clinicians in visualizing cardiac anatomy/pathology and quantifying atherosclerotic plaques; supports clinical decision-making through targeted workflows and custom UI.
Clinical Evidence
No clinical data. Evidence consists of bench testing, including software requirements verification, design validation, and traceability matrix analysis to confirm performance, functionality, and reliability.
Technological Characteristics
Medical image processing software; DICOM-compliant. Features include cardiac function analysis, coronary artery extraction, calcium scoring, and cardiac fusion. Software-based; operates on standard hardware platforms. Moderate level of concern per FDA software guidance. No specific materials or energy sources; standalone software application.
Indications for Use
Indicated for trained medical professionals to aid in reading, interpreting, reporting, and treatment planning using DICOM-compliant CT, MR, NM, and XA images. Applications include functional cardiac analysis (CT/MR), coronary artery analysis (CT/MR), calcium scoring (non-contrast CT), and cardiac fusion. Not for primary diagnostic interpretation of mammography.
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}------------------------------------------------
# 5. 510(k) Summary
Date Prepared:
February 28, 2012
## Submitter's Information:
FUJIFILM Medical Systems U.S.A., Inc. 419 West Avenue Stamford, Connecticut 06902
Telephone: (301) 251-1092 Fax: (203) 602-3785
- Contact: Jyh-Shyan Lin
## Device Trade Name:
Synapse 3D Cardiac Tools
### Device Common Name:
Medical Image Processing and Analysis Software
#### Regulation Number:
21 CFR 892 2050
#### Device Classification:
Class II
#### Device Classification Name :
Picture Archiving and Communications System (PACS)
#### Panel:
Radiology
### Product Code:
LLZ
## Date Received:
TBD
#### Decision Date:
TBD
Decision:
TBD
5 2012 -JUL
{1}------------------------------------------------
#### Predicate Device:
- Synapse 3D Cardiac Tools, FUJIFILM Medical Systems U.S.A., Inc. (K103465) .
- QPlaque MR, Medical Imaging Systems, B.V. (K073156) .
#### Description of the Device
- Synapse 3D Cardiac Tools (V3.0) is the updated version of previously-cleared Synapse 3D Cardiac Tools software (cleared by CDRH via K103465 on 01/31/2011).
Synapse 3D Cardiac Tools is used in addition to the Synapse 3D Base Tools (K120361, cleared on April 6, 2012) to analyze the images acquired from CT and MR. Synapse 3D Cardiac Tools is intended to provide trained medical professionals with tools to aid them in reading, interpreting, reporting, and treatment planning of DICOM compliant medical images. This product is not intended for use with or for the primary diagnostic interpretation of mammography images.
Synapse 3D Cardiac Tools (V3.0) is an application that supports the cardiac function, cardiac fusion, and coronary artery analysis of both the computed tomography (CT) and magnetic resonance (MR) images. Synapse 3D Cardiac Tools also supports the calcium scoring for noncontrast CT images.
#### Unchanged Applications from the cleared version K103465
- (1) Cardiac Function (CT)
Cardiac Function (CT) is an application for cardiac function evaluation which obtains the boundary between left ventricle and cardiac wall from CT left ventriculography images retrieved from multiple time phases and calculates ejection fraction, end-diastolic volume, end-systolic volume, stroke volume, etc.
- (2) Cardiac Function (MR)
Cardiac Function (MR) is an application for cardiac function evaluation which obtains the boundary between left ventricle and cardiac wall from non-contrasted MR images retrieved from multiple time phases and calculates ejection fraction, end-diastolic volume, endsystolic volume, output volume per beat, etc.
- (3) Coronary Arterv Analysis (CT)
Coronary Artery Analysis (CT) is an application using CT coronary arteriography images to extract the path of the target blood vessels and to perform coronary artery evaluation.
- (4) Calcium Scoring
The calcium scoring is an application which uses non-contrasted CT images to display the calcification area in the coronary artery with color separation and calculates the calcification quantitative values using the Agatston score method.
- (5) Cardiac fusion
Cardiac fusion is an application to create an image having the mutual characteristics of source images of heart. Source images could be original image of CT, MR or NM and the functional image derived from the original image.
05 - 2
{2}------------------------------------------------
#### New Application
- (6) Coronary Artery Analysis (MR)
Coronary Artery Analysis (MR) is an application using contrast or non-contrast MR heart images to extract the path of the target blood vessels and to perform coronary artery evaluation.
Note: The detail features available in this application are very similar to those in the Coronary Artery Analysis (CT).
In addition to the common image processing functions (such as window width and window level, zooming, panning, flip, rotation, adding annotations on an image, measurement of lengths, areas, etc.), the following image processing tools are available to support the cardiac analysis of the CT and MR images. These tools belong to and are provided by Synapse 3D Base Tools (K120361) that is used with Synapse 3D Cardiac Tools (V3.0).
- SUV evaluation: SUV average, standard deviation, etc. can be measured. .
- Extraction and Deletion of 3D objects: Editing of mask areas using the smart cut feature. ●
- 3D clipping: The display area can be specified for 3D display.
- Organ segmentation and removal: Organs and other areas of interest in the image data . can be segmented or removed.
- Mask editing: The mask area can be edited by lines drawn in freehand. ●
- . CPR: CPR images can be created along a specified center line.
- Reformat: Plane images in any direction can be created. .
- Creation of video files: Video files with 2D or 3D display can be created. .
- . Surface display: A polygon model of an image can be created.
#### Indication for Use
Synapse 3D Cardiac Tools is medical imaging software used with Synapse 3D Base Tools that is intended to provide trained medical professionals with tools to aid them in reading, interpreting, reporting, and treatment planning. Synapse 3D Cardiac Tools accepts DICOM compliant medical images acquired from a variety of imaging devices including, CT, MR, NM, and XA.
This product is not intended for use with or for the primary diagnostic interpretation of Mammography images.
Addition to the tools in Synapse 3D Base Tools, Synapse 3D Cardiac Tools provides the tools for specific clinical applications which provide targeted workflows, custom Ul, targeted measurements and reporting functions including:
- > Functional cardiac analysis for CT left ventriculography images: which is intended to evaluate the functional characteristics of heart
- > Functional cardiac analysis for non-contrast MR heart images: which is intended to evaluate the functional characteristics of heart ·
05 - 3
{3}------------------------------------------------
- Coronary artery analysis for CT coronary arteriography images: which is intended for the A qualitative and quantitative analysis of coronary arteries
- > Coronary artery analysis for MR heart images: which is intended for the qualitative and quantitative analysis of coronary arteries
- > Calcium scoring for non-contrast CT heart images: which is intended for non-invasive identification and quantification of calcified atherosolerotic plaques in the coronary arteries using tomographic medical image data and clinically accepted calcium scoring algorithms
- > Cardiac Fusion: which is intended to analyze cardiac anatomy and pathology with a fused image of functional data (e.g. NM image, Bulls eye) and anatomical data.
## Technological Characteristics
Synapse 3D Cardiac Tools introduces no new safety or efficacy issues other than those already indentified with the predicate devices. The results of the Hazard Analysis combined with the appropriate preventive measures taken indicate that the device is of moderate concern as per the May 11, 2005 issue of the "Guidance for the Content of Premarket Submission for Software Contained in Medical Devices."
## Testing
Synapse 3D Cardiac Tools is tested successfully with reference to its Software Requirements Specification, as well as design verification and validation documents and Traceability Matrix document. Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the Synapse 3D Cardiac Tools software, which is found to be safe and effective and substantially equivalent to the currently-cleared predicate device.
## Conclusion
This 510(k) premarket notification submission 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. We conclude the subject device to be as safe and effective as the predicate devices.
{4}------------------------------------------------
Image /page/4/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name in a circular arrangement around a stylized symbol. The symbol consists of a stylized caduceus, which is a traditional symbol of medicine, with a double-stranded snake winding around a staff. The seal is in black and white.
## DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
FUJIFILM Medical Systems U.S.A., Inc. C/O JY-SHYAN LIN, Ph.D. Senior Manager, Regulatory, Quality and Clinical Affairs 419 West Avenue Stamford, Connecticut 06902
5 2012 JUL
Re: K120636
Trade/Device Name: Synapse 3D Cardiac Tools Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving and Communications System (PACS) Regulatory Class: Class II Product Code: LLZ Dated: June 21, 2012 Received: June 22, 2012
Dear Mr. Lin:
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 101 use stated in the encreases, it together than the of the Medical Device Amendments, or to commores that have been reclassified in accordance with the provisions of the Federal Food, Drug, de vices that nave been receasined in assere approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The Tournal controls provisions of the Act include requirements for annual registration, listing of general controll pro reserving 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 11 your device is elaborited (ove as regulations affecting your device can be found in Title 21, additional controls. Extraing mayor regulation, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination and mean that FDA has made a determination that your device complies with other requirements of the Act that I DA has made a dolor regulations administered by other Federal agencies. You must of any rederal statutes and regenances including, but not limited to: registration and listing (21) Comply with an the Act 3 requirements, articles, " , " , " , " , " , " , " , " , " , " , " , " , " , " , " , " , " , " , " , " , " , " , " , " , " , " , " , " , " , " , " , "
{5}------------------------------------------------
medical device-related adverse events) (21 CFR 803); and good manufacturing practice medical device-related active systems (QS) regulation (21 CFR Part 820). This letter requireliens as set forth in the quality of evice as described in your Section 510(k) premarket will anow you to begin mationing your as not a equivalence of your device to a legally marketed nonication. The I Drivinang of sication 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 CFF Pats 801 and 11 you desire specific darree 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
under the MDA regulation (2) "CFFF at 000), portal roblem/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 Tou may other other gettivers, 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
{6}------------------------------------------------
# Indications for Use
### 510(k) Number (if known):
Device Name: Synapse 3D Cardiac Tools
Indications for Use:
Synapse 3D Cardiac Tools is medical imaging software used with Synapse 3D Base Tools Ontapor of our of trained medical professionals with tools to aid them in reading, interpreting, reporting, and treatment planning. Synapse 3D Cardiac Tools accepts DICOM incompliant medical images acquired from a variety of imaging devices including, CT, MR, NM, and XA.
This product is not intended for use with or for the primary diagnostic interpretation of Mammography images.
Addition to the tools in Synapse 3D Base Tools, Synapse 3D Cardiac Tools provides the tools for specific clinical applications which provide targeted workflows, custom Ul, targeted measurements and reporting functions including:
- > Functional cardiac analysis for CT left ventriculography images: which is intended to evaluate the functional characteristics of heart
- > Functional cardiac analysis for non-contrast MR heart images: which is intended to evaluate the functional characteristics of heart
- > Coronary artery analysis for CT coronary arteriography images: which is intended for the qualitative and quantitative analysis of coronary arteries
- > Coronary artery analysis for MR heart images: which is intended for the qualitative and quantitative analysis of coronary arteries
- > Calcium scoring for non-contrast CT heart images: which is intended for non-invasive identification and quantification of calcified atherosclerotic plaques in the coronary arteries using tomographic medical image data and clinically accepted calcium scoring algorithms
- > Cardiac Fusion: which is intended to analyze cardiac anatomy and pathology with a fused image of functional data (e.g. NM image, Bulls eye) and anatomical data.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
***(Division Sign-Off)***
Page 1 of
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K
Synapse 3D Cardiac Tools V3.0 510(k) Submission
22 of 1881
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.
