K051553 · Fujifilm Medical Systems U.S.A, Inc. · LLZ · Jul 7, 2005 · Radiology
Device Facts
Record ID
K051553
Device Name
FUJI SYNAPSE WORKSTATION SOFTWARE
Applicant
Fujifilm Medical Systems U.S.A, Inc.
Product Code
LLZ · Radiology
Decision Date
Jul 7, 2005
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 892.2050
Device Class
Class 2
Attributes
Software as a Medical Device, 3rd-Party Reviewed
Indications for Use
Fuji Synapse Workstation Software is intended for installation on an off-the-shelf PC meeting or exceeding minimum specifications and networked with Fuji Synapse PACS. The Fuji Synapse Workstation is intended to serve as the primary user interface for the processing of medical images for presentation on displays appropriate to the medical task being performed. The Synapse Workstation can process medical Images from the following modality types: plane X-ray radiography, X-ray computed tomography, magnetic resonance imaging, ultrasound, nuclear medicine and images from other DICOM compliant modalities. The Synapse Workstation may be used for the display, manipulation, and interpretation of lossless compressed or non-compressed mammography images that have been received in the DICOM For Presentation format and displayed on FDA cleared, DICOM compatible, displays. Synapse does not provide spatial frequency enhancement, dynamic range control, or multi-objective frequency image processing for DICOM MG "For Presentation" mammography images.
Device Story
Synapse Workstation Software functions as primary user interface for Fuji Synapse PACS; installed on off-the-shelf PCs. Inputs: DICOM-compliant medical images (X-ray, CT, MRI, ultrasound, nuclear medicine, mammography). Processing: folder-based navigation; workflow scripting; hanging protocols; image manipulation (window/level, magnification, density). Output: processed images for clinical display. Used in clinical settings by healthcare professionals for diagnostic interpretation. Benefits: centralized access to radiological data; productivity enhancement via customizable workflows; standardized image presentation.
Clinical Evidence
Bench testing only. No clinical data provided. Safety and efficacy established through hazard analysis, risk management, and verification/validation testing of software functions.
Technological Characteristics
Software-based workstation for off-the-shelf PCs. Connectivity: Networked with Fuji Synapse PACS via DICOM 3.0. Hardware standards: IEC60950 (safety), IEC/CISPR 22 (emissions). Image processing: Window/level, magnification, density adjustment. Software class: Minor level of concern per FDA guidance.
Indications for Use
Indicated for clinicians requiring display, manipulation, and interpretation of medical images from X-ray, CT, MRI, ultrasound, nuclear medicine, and other DICOM-compliant modalities, including mammography. No specific age or gender restrictions; contraindications not specified.
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
CR Console (Flash IIP), Fuji Medical Systems
Light Beam Workstation, Amicas, Inc.
IDS5/mx.net Workstation, Sectra Imtec AB
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image shows the Fujifilm logo. The logo consists of a stylized graphic element on the left, followed by the word "FUJIFILM" in bold, sans-serif font. Below the main logo, the text "I&I-Imaging & Information" is printed in a smaller, sans-serif font. The logo is black and white.
FUJIFILM MED
419 WEST AVENUE STAMFORD, CT 06902 Telephone: 203/324-2000 Fax: 203/353-0926
JUL - 7 2005
# 510(K) Summary
In accordance with the requirements of the Safe Medical Device Act, FUJIFILM Medical Systems, USA, Inc. herewith submits a 510(K) summary for the following device.
| Submitter Name / Address: | FUJIFILM Medical Systems, USA, Inc.<br>419 West Avenue<br>Stamford, CT 06902 |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------|
| Contact Person / Tel No .: | Rob Berry<br>Director of Quality Assurance and Regulatory Affairs |
| Date Summary Prepared: | March 28, 2005 |
| Establishment No.: | 2443168 |
| Trade/Proprietary Name: | Fuji Synapse Workstation Software |
| Common/Usual Name: | Medical Image Processing Workstation |
| Classification Name: | Picture archiving and communications system |
| Class/Panel: | Class II, 90-LLZ, 21CFR 892.2050 |
| Predicate Device(s): | CR Console (Flash IIP), Fuji Medical Systems<br>Light Beam Workstation, Amicas, Inc.<br>IDS5/mx.net Workstation, Sectra Imtec AB |
### Device Description:
The Synapse Workstation provides viewing and manipulation of radiological data including images, reports, patient status, and clinical information.
The workstation utilizes a folder structure providing easy navigation and organization of images, studies, documents, etc. that most users are familiar with from Microsoft Explorer and other Windows applications. The workstation contains workflow scripting and hanging protocols designed to maximize productivity and allow each user to tailor the workstation operation to their individue looging
In addition to common image manipulation functions such as windowlevel and windowlydth variation, magnification, density value, etc., the Synapse Workstation provides more advanced image processing, including processing of CR and CT images.
### Intended Use:
Fuji Synapse Workstation Software is intended for installation on an off-the-shelf PC meeting or Wedness with minimum specifications and networked with Fuji Synapse PACS. The Fuji Synapse Workstation is intended to serve as the primary user interface for the Tribe. The Trip Synchise presentation on displays appropriate to the medical task being performed. The Synapse Workstation can process medical images from the following modality types: plane X-ray radiography (including cagal
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Image /page/1/Picture/0 description: The image shows the Fujifilm logo. The logo consists of a stylized square with the letters "Fuji" inside, followed by the word "FUJIFILM" in bold, sans-serif font. Below the word "FUJIFILM" is the text "I&I-Imaging & Information" in a smaller, sans-serif font.
FUJIFILM MEDICAL SYSTEMS USA, INC.
419 WEST AVENUE STAMFORD, CT 06902 Telephone: 203/324-2000 Fax: 203/353-0926
mammography), X-ray computed tomography, magnetic resonance imaging, ultrasound, nuclear medicine and images from other DICOM compliant modalities. Technological Characteristics and Predicates Devices:
The Fuji Synapse Workstation is comparable and substantially equivalent to the Light Beam Workstation manufactured by Amicas, Inc. as a PACS Workstation and is comparable and substantially equivalent to the image processing capabilities of the CR Console manufactured by Fuji.
#### Safety Information:
The Synapse Workstation Software introduces no new safety and efficacy issues other than those already identified with the predicate devices. The results of a hazard analysis, combined with the appropriate preventive measures taken indicate that the device is of minor level of concern as per the May 29, 1998 issue of the "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".
The Instructions for Use contains precautions and warnings for safe and effective use of the device.
Potential hazards are identified through risk analysis and managed through the software development process and verification/validation testing.
The Synapse Workstation complies with the following mandatory and voluntary standards:
- ACR/NEMA DICOM Version 3.0 (Digital Imaging and Communications in Medicine) developed by . the American College of Radiology and the National Electrical Manufacturers Association. The Synapse DICOM Conformance Statement has been included in the Labeling section as Appendix F3.
Recommended Specifications for Workstation Hardware include compliance with the following standards:
- General Safety standards for all hardware: IEC60950 or equivalent. .
- Information Technology Equipment, Radio Disturbance (Emissions) Characteristics-Limits and . Methods of Measurements, IEC/CISPR 22 (EN55022)
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". Inside the circle is a stylized symbol that resembles a caduceus, with three abstract human profiles forming the staff and a flowing, ribbon-like design representing the snakes. The overall design is simple and conveys a sense of authority and professionalism.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
MAY 23 2011
Ms. Debra A. Peacock Regulatory Affairs FUJIFILM Medical Systems U.S.A., Inc. 419 West Avenue STAMFORD CONNECTICUT 06902 U.S.A.
Re: K051553
Trade/Device Name: Fuji Synapse Workstation Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: June 28, 2005 Received: June 29, 2005
Dear Ms. Peacock:
This letter corrects our substantially equivalent letter of July 7, 2005.
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 (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely Yours,
Mary S. 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
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## Indications For Use
051553
510(k) Number (if known):
Device Name: Fuji Synapse Workstation
Indications For Use:
Fuji Synapse Workstation Software is intended for installation on an off-the-shelf PC meeting or exceeding minimum specifications and networked with Fuji Synapse PACS. The Fuji Synapse Workstation is intended to serve as the primary user interface for the processing of medical images for presentation on displays appropriate to the medical task being performed. The Synapse Workstation can process medical Images from the following modality types: plane X-ray radiography, X-ray computed tomography, magnetic resonance imaging, ultrasound, nuclear medicine and images from other DICOM compliant modalities.
The Synapse Workstation may be used for the display, manipulation, and interpretation of lossless compressed or non-compressed mammography images that have been received in the DICOM For Presentation format and displayed on FDA cleared, DICOM Synapse does not provide spatial frequency enhancement, compatible, displays. dynamic range control, or mulli-objective frequency image processing for DICOM MG "For Presentation" mammography images.
Prescription Use (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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancyc Brogdon
Division Sign-Off
Division of Reproductive, Abdominal, and
Radiological Devices,
10(k) Number K051553
Page 1 of 1 Appendix B2 - Page 1
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
