510(k) Report

510(k) · Cleared

Recalled · Class II · 2016

Synapse Workstation Software Version 3.3.0

K112439510(k) TraditionalCleared Oct 17, 201154-day reviewClass II21 CFR 892.2050Recalls 2

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

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

Cleared on Oct 17, 2011 as substantially equivalent to K051553 (Fujifilm Medical Systems U.S.A, Inc., 2005) and 1 other predicate after a 54-day review. Its family tree reaches back 1 generation to 2005. 11 later devices descend from it. It has been recalled 2 times.

Decided
Oct 17, 2011
Review
54 days
Class
Class II
Product code
LLZ
Recalls
2
Predicates
2

Its longest line of descent runs back 1 generation to K051553 (2005). 2 ancestors in all. 11 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2006: 1 other ancestor2016: 2 descendants cleared2017: 3 descendants cleared2019: 3 descendants cleared2024: 1 descendant cleared2025: 1 descendant cleared2026: 1 descendant clearedK051553 · Fuji Synapse Workstation Software · Fujifilm Medical Systems U.S.A, Inc. · 2005 · recalled20052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 5 descendants3 generations forward: 3 descendants4 generations forward: 1 descendant K051553 · Fuji Synapse Workstation Software · Fujifilm Medical Systems U.S.A, Inc. · 2005 · recalled0
  1. Root · 1 generation backK051553 Fuji Synapse Workstation SoftwareFujifilm Medical Systems U.S.A, Inc. · 2005 · Recalled
  2. This deviceK112439 Synapse Workstation Software Version 3.3.0Fujifilm Medical System U.S.A., Inc. · 2011
  3. Descendant · cites it directly · 8 of its ownK160108 Synapse PACSFujifilm Medical Systems U.S.A, Inc. · 2016 · Recalled
  4. Descendant · 2 generations on · 3 of its ownK190232 Synapse PACSFujifilm Corporation · 2019 · Recalled
  5. Descendant · 3 generations on · 1 of its ownK243647 Synapse PACS (7.5)FUJIFILM Healthcare Americas Corporation · 2025
  6. Descendant · 2 generations on · 1 of its ownK173475 Merge PACSMerge Healthcare Incorporated · 2017 · Recalled
  7. Descendant · cites it directly · 1 of its ownK162145 vRad PACS with MammographyVirtual Radiologic Corporation · 2016 · Recalled

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2016: 22017: 32019: 32024: 12025: 12026: 1
2016high 3 (2017) · low 0 (2018)2026

Most influential descendants

Showing 5 of 11 · See all
  • K160108Synapse PACSFujifilm Medical Systems U.S.A, Inc. · 2016 · cites it directly8descendants
  • K190232Synapse PACSFujifilm Corporation · 2019 · 2 generations on3descendants
  • K243647Synapse PACS (7.5)FUJIFILM Healthcare Americas Corporation · 2025 · 3 generations on1descendant
  • K173475Merge PACSMerge Healthcare Incorporated · 2017 · 2 generations on1descendant
  • K162145vRad PACS with MammographyVirtual Radiologic Corporation · 2016 · cites it directly1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K051553Fuji Synapse Workstation SoftwareFujifilm Medical Systems U.S.A, Inc.20051
0 (this device)K112439Synapse Workstation Software Version 3.3.0Fujifilm Medical System U.S.A., Inc.2011—
+1K160108Synapse PACSFujifilm Medical Systems U.S.A, Inc.20164
+2K190232Synapse PACSFujifilm Corporation201911
+3K243647Synapse PACS (7.5)FUJIFILM Healthcare Americas Corporation2025—
+2K173475Merge PACSMerge Healthcare Incorporated20172
+1K162145vRad PACS with MammographyVirtual Radiologic Corporation20161

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201620
201730
201930
202410
202510
202610
FIG. 1 — Lineage of K112439, 2005–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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? (2)

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
*K051553Fuji Synapse Workstation Software
Summary page 1
…sing Workstation Picture Archiving and Communications Systems (PACS) 2443168 Radiology Class Il LLZ 21CFR 892.2050 Fuji Synapse Workstation Software Version 3.1.0 (K051553) Fuji's Computed Radiography Mammography Suite (FCRMS) software (P050014) Synapse Workstation Software Version 3.3.0 Page 26 of…
Fujifilm Medical Systems U.S.A, Inc.20051
*P050014Fuji's Computed Radiography Mammography Suite (Fcrms)
Summary page 1
…168 Radiology Class Il LLZ 21CFR 892.2050 Fuji Synapse Workstation Software Version 3.1.0 (K051553) Fuji's Computed Radiography Mammography Suite (FCRMS) software (P050014) Synapse Workstation Software Version 3.3.0 Page 26 of 1644 Description of Device: The FUJIFILM Synapse Worksta…
Fujifilm Medical System U.S.A., Inc.20061

Also cleared against K051553: 5 other devices →

What descends from it? (11)

See all 11

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

NumberDeviceApplicantDecidedDescendants
K160108Synapse PACSFujifilm Medical Systems U.S.A, Inc.20168
K162145vRad PACS with MammographyVirtual Radiologic Corporation20161

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

Recalls of this device

DateClassRecallRoot causeReason
Sep 15, 2016Class IIZ-0073-2017Software designImage data for a patients image may not be correct
May 10, 2016Class IIZ-2043-2016Software designSynapse cannot display image files, DICOM SR files, and/or Annotation files. The "Image Not Loaded" message displays instead

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • 2 of the 2 ancestors have a recall of any class.
  • Of its descendants, K160108 (Fujifilm Medical Systems U.S.A, Inc., 2016) has gone furthest, with 8 descendants of its own.
  • 5 other devices also cite its predicate K051553.

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. 2011, this device’s year, is highlighted.

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?

FUJIFILM 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 FUJIFILM 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…

Read the full statement (132 words)

FUJIFILM 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 FUJIFILM 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 to process DICOM MG “For Processing” images and also 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 for mammography.

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

Also cleared against K051553

5 other devices cite the same predicate.

  • K140909Mckesson RadiologyMckesson Medical Imaging Company · 20144 recalls
  • K112008Touchpacs SuiteTouch Medical Solutions, Inc. · 2012
  • K100236Stair Systems Pacs & Dicom ViewerStair Systems, Inc. · 2010
  • K091631Accessnet, Accessmed, Accessrad, MedviewAspyra, Inc. · 2010
  • K090649Vrad Picture Archiving and Communications System SoftwareVirtual Radiologic Corporation · 2009

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

74 FDA decisions under this applicant name. See the company

  • K163675Processor VP-7000, Light Source BL-7000Fujifilm Medical System U.S.A., Inc. · 2017
  • K153206Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1Fujifilm Medical System U.S.A., Inc. · 2016
  • K151474Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter (ClutchCutter)Fujifilm Medical System U.S.A., Inc. · 2016
  • K152138FDR D-EVO GL Flat Panel Detector SystemFujifilm Medical System U.S.A., Inc. · 2015
  • K150221EPX-4440HD and EPX-4400HD with FICEFujifilm Medical System U.S.A., Inc. · 2015

Recent decisions in LLZ

The LLZ category page

  • K261788Eden PACSHigia., Inc. d/b/a Eden · 2026
  • K261531PV-iCurve ProPerception Vision Medical Technology Co., Ltd. · 2026
  • K263048Syngo Carbon Space (VA4)Siemens Healthineers AG · 2026
  • K261874Syneris PACS v.1.0.1.0Syneris · 2026
  • K262442HipStudio AnalysisReplasia BV · 2026

https://510kreport.com/device/K112439 · printed Nov 6, 2026

Cite this page

510(k) Report. “K112439: Synapse Workstation Software Version 3.3.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112439

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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