510(k) Report

510(k) · Cleared

Recalled · 2006

Fuji Synapse Workstation Software

K051553510(k) TraditionalCleared Jul 7, 200524-day reviewClass II21 CFR 892.2050Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Fujifilm Medical Systems U.S.A, Inc. · LLZ System, Image Processing, Radiological

Cleared on Jul 7, 2005 after a 24-day review. The FDA summary names its predicate without a number. 19 later devices descend from it. It has been recalled once.

Decided
Jul 7, 2005
Review
24 days
Class
Class II
Product code
LLZ
Recalls
1
Predicates
0

19 later devices descend from it, 6 citing it directly.

Descendants, by year cleared 2009: 2 descendants cleared2012: 1 descendant cleared2010: 2 descendants cleared2011: 1 descendant cleared2014: 1 descendant cleared2016: 2 descendants cleared2017: 4 descendants cleared2019: 3 descendants cleared2024: 1 descendant cleared2025: 1 descendant cleared2026: 1 descendant cleared20052010201520202025
  1. This deviceK051553 Fuji Synapse Workstation SoftwareFujifilm Medical Systems U.S.A, Inc. · 2005
  2. Descendant · cites it directly · 11 of its ownK112439 Synapse Workstation Software Version 3.3.0Fujifilm Medical System U.S.A., Inc. · 2011 · Recalled
  3. Descendant · 2 generations on · 8 of its ownK160108 Synapse PACSFujifilm Medical Systems U.S.A, Inc. · 2016 · Recalled
  4. Descendant · 3 generations on · 3 of its ownK190232 Synapse PACSFujifilm Corporation · 2019 · Recalled
  5. Descendant · cites it directly · 2 of its ownK090649 Vrad Picture Archiving and Communications System SoftwareVirtual Radiologic Corporation · 2009
  6. Descendant · 4 generations on · 1 of its ownK243647 Synapse PACS (7.5)FUJIFILM Healthcare Americas Corporation · 2025

Showing 5 of 19 descendants. See all descendants

Descendants cleared per year

2009: 22010: 22011: 12012: 12014: 12016: 22017: 42019: 32024: 12025: 12026: 1
2009high 4 (2017) · low 0 (2013)2026

Most influential descendants

Showing 5 of 19 · See all
  • K112439Synapse Workstation Software Version 3.3.0Fujifilm Medical System U.S.A., Inc. · 2011 · cites it directly11descendants
  • K160108Synapse PACSFujifilm Medical Systems U.S.A, Inc. · 2016 · 2 generations on8descendants
  • K190232Synapse PACSFujifilm Corporation · 2019 · 3 generations on3descendants
  • K090649Vrad Picture Archiving and Communications System SoftwareVirtual Radiologic Corporation · 2009 · cites it directly2descendants
  • K243647Synapse PACS (7.5)FUJIFILM Healthcare Americas Corporation · 2025 · 4 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K051553Fuji Synapse Workstation SoftwareFujifilm Medical Systems U.S.A, Inc.2005—
+1K112439Synapse Workstation Software Version 3.3.0Fujifilm Medical System U.S.A., Inc.20112
+2K160108Synapse PACSFujifilm Medical Systems U.S.A, Inc.20164
+3K190232Synapse PACSFujifilm Corporation201911
+1K090649Vrad Picture Archiving and Communications System SoftwareVirtual Radiologic Corporation2009—
+4K243647Synapse PACS (7.5)FUJIFILM Healthcare Americas Corporation2025—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200920
201020
201110
201210
201410
201620
201740
201930
202410
202510
202610
FIG. 1 — Lineage of K051553, 2005–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LLZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new LLZ device

  1. #1 K230955 syngo Application Softwarescore 21.5 · 11 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (4)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*—CR Console (Flash IIP)
Named without a submission number
—
*—Light Beam Workstation
Named without a submission number
—
*—Arnicas, Inc.
Named without a submission number
—
*—IDS5/mx.net Workstation
Named without a submission number
—

What descends from it? (19)

See all 19

6 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K112439Synapse Workstation Software Version 3.3.0Fujifilm Medical System U.S.A., Inc.201111
K090649Vrad Picture Archiving and Communications System SoftwareVirtual Radiologic Corporation20092
K100236Stair Systems Pacs & Dicom ViewerStair Systems, Inc.20101
K140909Mckesson RadiologyMckesson Medical Imaging Company20140
K112008Touchpacs SuiteTouch Medical Solutions, Inc.20120
K091631Accessnet, Accessmed, Accessrad, MedviewAspyra, Inc.20100

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Feb 3, 2006Not classifiedZ-0622-06OtherImage orientation and orientation markers may not match when an image is rotated or flipped when the CT Image is preset.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K112439 (Fujifilm Medical System U.S.A., Inc., 2011) has gone furthest, with 11 descendants of its own.

How does its category compare?

All LLZ devices

LLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LLZ

58in 2025

2007: 762008: 942009: 702010: 512011: 1062012: 822013: 952014: 782015: 642016: 822017: 782018: 1042019: 742020: 812021: 832022: 652023: 872024: 622025: 582026 (partial year): 45
2007high 106 (2011) · low 51 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LLZ

173in 2025

2007: 36 days median2008: 52 days median2009: 62 days median2010: 98 days median2011: 79 days median2012: 87 days median2013: 84 days median2014: 89 days median2015: 90 days median2016: 90 days median2017: 107 days median2018: 105 days median2019: 107 days median2020: 115 days median2021: 116 days median2022: 137 days median2023: 157 days median2024: 131 days median2025: 173 days median2026 (partial year): 110 days median
2007high 173 (2025) · low 36 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LLZ

11in 2025

2007: 202008: 322009: 212010: 172011: 302012: 122013: 642014: 62015: 162016: 122017: 52018: 72019: 22020: 62021: 32022: 42023: 82024: 62025: 112026 (partial year): 14
2007high 64 (2013) · low 2 (2019)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LLZ

116in 2025

2007: 1522008: 1542009: 1452010: 1452011: 4542012: 2662013: 1,1302014: 15,6312015: 2112016: 2902017: 1042018: 722019: 882020: 822021: 702022: 282023: 262024: 422025: 116
2007high 15,631 (2014) · low 26 (2023)2025

MAUDE reports naming product code LLZ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007763620152
2008945232154
2009706221145
2010519817145
20111067930454
2012828712266
20139584641,130
20147889615,631
2015649016211
2016829012290
2017781075104
2018104105772
201974107288
202081115682
202183116370
202265137428
202387157826
202462131642
20255817311116
20264511014—

What is it indicated for?

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…

Read the full statement (143 words)

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 tleared, DICOM compatible, displays. Synapse does not provide spatial frequency enhancement, dynamic range control, or mulli-objective frequency image processing for DICOM MG “For Presentation” mammography images.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Fujifilm Medical Systems U.S.A, Inc.

44 FDA decisions under this applicant name. See the company

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  • P160031/S003ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) OptionFujifilm Medical Systems U.S.A, Inc. · 2020
  • P160031/S002Aspire Cristalle Digital Breast Tomosynthesis OptionFujifilm Medical Systems U.S.A, Inc. · 2019
  • P160031/S001ASPIRE Cristalle Breast Tomosynthesis SystemFujifilm Medical Systems U.S.A, Inc. · 2019
  • K171291FUJIFILM Bronchoscope Model EB-530PFujifilm Medical Systems U.S.A, Inc. · 2018

Recent decisions in LLZ

The LLZ category page

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  • K263048Syngo Carbon Space (VA4)Siemens Healthineers AG · 2026
  • K261874Syneris PACS v.1.0.1.0Syneris · 2026
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https://510kreport.com/device/K051553 · printed Nov 6, 2026

Cite this page

510(k) Report. “K051553: Fuji Synapse Workstation Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051553

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026