510(k) · Cleared
Recalled · Class II · 2025Synapse PACS
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fujifilm Medical Systems U.S.A, Inc. · LLZ System, Image Processing, Radiological
Cleared on Feb 3, 2016 as substantially equivalent to K112439 (Fujifilm Medical System U.S.A., Inc., 2011) and 1 other predicate after a 15-day review. Its family tree reaches back 11 generations to 1991. 8 later devices descend from it. It has been recalled 4 times.
- Decided
- Feb 3, 2016
- Review
- 15 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- 4
- Predicates
- 2
Its longest line of descent runs back 11 generations to K913770 (1991). 111 ancestors in all, the oldest K871859 (1987). 8 later devices descend from it, 4 citing it directly.
- Root · 11 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 7 generations between
- 3 generations backK091373 Syngo TruedSiemens Medical Solutions USA, Inc. · 2009
- 2 generations backK101228 Mirada XDMirada Medical, Ltd. · 2010
- 1 generation backK113244 Synapse MPR FusionFujifilm Medical System U.S.A., Inc. · 2011
- This deviceK160108 Synapse PACSFujifilm Medical Systems U.S.A, Inc. · 2016
- Descendant · cites it directly · 3 of its ownK190232 Synapse PACSFujifilm Corporation · 2019 · Recalled
- Descendant · 2 generations on · 1 of its ownK243647 Synapse PACS (7.5)FUJIFILM Healthcare Americas Corporation · 2025
- Descendant · cites it directly · 1 of its ownK173475 Merge PACSMerge Healthcare Incorporated · 2017 · Recalled
- Descendant · 3 generations on · 0 of its ownK261713 Synapse PACS (7.6.0)FUJIFILM Healthcare Americas Corporation · 2026
- Descendant · 2 generations on · 0 of its ownK192508 Medsynapse Ris Pacs & Medsynapse VNAMedsynaptic Private, Ltd. · 2019
Show all 11 generations
- Root · 11 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 10 generations backK963345 Advantage Windows Tissue Volume OptionGE Medical Systems · 1996
- 9 generations backK013381 Advanced Lung Analysis-1General Electric Co. · 2001
- 8 generations backK022013 Lungcare CT Software PackageSiemens Medical Solutions USA, Inc. · 2002
- 7 generations backK033374 Lungcare CT Software Package with Extended FunctionalitySiemens AG Medical Solutions · 2003
- 6 generations backK041484 UndecidedSiemens Medical Solutions USA, Inc. · 2004
- 5 generations backK053301 Cedara I-Response Cedara Pet/CTCedara Software Corp. · 2006
- 4 generations backK071950 Syngo TruedSiemens Medical Solutions USA, Inc. · 2007
- 3 generations backK091373 Syngo TruedSiemens Medical Solutions USA, Inc. · 2009
- 2 generations backK101228 Mirada XDMirada Medical, Ltd. · 2010
- 1 generation backK113244 Synapse MPR FusionFujifilm Medical System U.S.A., Inc. · 2011
- This deviceK160108 Synapse PACSFujifilm Medical Systems U.S.A, Inc. · 2016
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K190232Synapse PACSFujifilm Corporation · 2019 · cites it directly3descendants
- K243647Synapse PACS (7.5)FUJIFILM Healthcare Americas Corporation · 2025 · 2 generations on1descendant
- K173475Merge PACSMerge Healthcare Incorporated · 2017 · cites it directly1descendant
- K261713Synapse PACS (7.6.0)FUJIFILM Healthcare Americas Corporation · 2026 · 3 generations on0descendants
- K192508Medsynapse Ris Pacs & Medsynapse VNAMedsynaptic Private, Ltd. · 2019 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −10 | K963345 | Advantage Windows Tissue Volume Option | GE Medical Systems | 1996 | — |
| −9 | K013381 | Advanced Lung Analysis-1 | General Electric Co. | 2001 | — |
| −8 | K022013 | Lungcare CT Software Package | Siemens Medical Solutions USA, Inc. | 2002 | — |
| −7 | K033374 | Lungcare CT Software Package with Extended Functionality | Siemens AG Medical Solutions | 2003 | — |
| −6 | K041484 | Undecided | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −5 | K053301 | Cedara I-Response Cedara Pet/CT | Cedara Software Corp. | 2006 | — |
| −4 | K071950 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −3 | K091373 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2009 | — |
| −2 | K101228 | Mirada XD | Mirada Medical, Ltd. | 2010 | — |
| −1 | K113244 | Synapse MPR Fusion | Fujifilm Medical System U.S.A., Inc. | 2011 | — |
| 0 (this device) | K160108 | Synapse PACS | Fujifilm Medical Systems U.S.A, Inc. | 2016 | — |
| +1 | K190232 | Synapse PACS | Fujifilm Corporation | 2019 | 11 |
| +2 | K243647 | Synapse PACS (7.5) | FUJIFILM Healthcare Americas Corporation | 2025 | — |
| +1 | K173475 | Merge PACS | Merge Healthcare Incorporated | 2017 | 2 |
| +3 | K261713 | Synapse PACS (7.6.0) | FUJIFILM Healthcare Americas Corporation | 2026 | — |
| +2 | K192508 | Medsynapse Ris Pacs & Medsynapse VNA | Medsynaptic Private, Ltd. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 4 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 4 | 0 |
| 1996 | 5 | 0 |
| 1997 | 4 | 0 |
| 1998 | 7 | 0 |
| 1999 | 3 | 0 |
| 2000 | 9 | 0 |
| 2001 | 13 | 0 |
| 2002 | 11 | 0 |
| 2003 | 7 | 0 |
| 2004 | 10 | 0 |
| 2005 | 5 | 0 |
| 2006 | 3 | 0 |
| 2007 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 3 | 0 |
| 2019 | 3 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
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 K230955 syngo Application Softwarescore 21.5 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K112439 | Synapse Workstation Software Version 3.3.0Summary page 4…Product Code: LLZ Regulation Number: 21 CFR 892.2050 Device Class: Class II Panel: Radiology Predicate Devices: • FUJIFILM Synapse Workstation Software (K112439) • Synapse MPR Fusion (K113244) 05 - 1 MEDICA… | 2011 |
| * | K113244 | Synapse MPR FusionSummary page 4…Number: 21 CFR 892.2050 Device Class: Class II Panel: Radiology Predicate Devices: • FUJIFILM Synapse Workstation Software (K112439) • Synapse MPR Fusion (K113244) 05 - 1 MEDICAL SYSTEMS U.S.A., Inc. Synapse PA… | 2011 |
What descends from it? (8)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 11, 2025 | Class II | Z-1407-2025 | Software change control | The incorrect computed patient age is showing in VX for patients less than 3 months old. |
| Mar 2, 2021 | Class II | Z-1348-2021 | Software design | The wrong patient information may be displayed in the viewer or PowerJacket. |
| Sep 11, 2020 | Class II | Z-0878-2021 | Device Design | There is a potential for the wrong patient information may be displayed in the viewer or PowerJacket. Additionally, the incorrect max standard uptake values (SUV) for PET ad CT studies may be returned for Siemens Modality. |
| May 22, 2020 | Class II | Z-2471-2020 | Software design | Lateromedial (LM) and Lateromedial Oblique (LMO) Orientation Markers may be displayed incorrectly on the 3D TOMO slider bar. In addition, the slice location of the image and/or the slice direction could be incorrect as well, and result in… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 8 companies; a new generation was cleared every 1.5 years on median.
- 27 of the 111 ancestors have a recall of any class.
- Of its descendants, K190232 (Fujifilm Corporation, 2019) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K112439.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 2025
MAUDE reports naming product code LLZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 76 | 36 | 20 | 152 |
| 2008 | 94 | 52 | 32 | 154 |
| 2009 | 70 | 62 | 21 | 145 |
| 2010 | 51 | 98 | 17 | 145 |
| 2011 | 106 | 79 | 30 | 454 |
| 2012 | 82 | 87 | 12 | 266 |
| 2013 | 95 | 84 | 64 | 1,130 |
| 2014 | 78 | 89 | 6 | 15,631 |
| 2015 | 64 | 90 | 16 | 211 |
| 2016 | 82 | 90 | 12 | 290 |
| 2017 | 78 | 107 | 5 | 104 |
| 2018 | 104 | 105 | 7 | 72 |
| 2019 | 74 | 107 | 2 | 88 |
| 2020 | 81 | 115 | 6 | 82 |
| 2021 | 83 | 116 | 3 | 70 |
| 2022 | 65 | 137 | 4 | 28 |
| 2023 | 87 | 157 | 8 | 26 |
| 2024 | 62 | 131 | 6 | 42 |
| 2025 | 58 | 173 | 11 | 116 |
| 2026 | 45 | 110 | 14 | — |
What is it indicated for?
FUJIFILM Synapse PACS Software (client) is intended for use, as a web based application, on an off-the-shelf PC meeting or exceeding minimum specifications and networked with FUJIFILM Synapse PACS Software (Server). The FUJIFILM Synapse PACS Software 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 PACS Software can process…
Read the full statement (182 words)
FUJIFILM Synapse PACS Software (client) is intended for use, as a web based application, on an off-the-shelf PC meeting or exceeding minimum specifications and networked with FUJIFILM Synapse PACS Software (Server). The FUJIFILM Synapse PACS Software 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 PACS Software 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 FUJIFILM Synapse PACS Software enables the display, comparison and fusion of 3D (MIP/MPR) of CT, MR, PET and SPECT studies. Typical users are radiologists, technologists and clinicians. These functions (MIP/MPR/Fusion) are not intended for Mammography use.
The FUJIFILM Synapse PACS Software may be used to process FUJIFILM’s 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 as stated in the FDA summary.
https://510kreport.com/device/K160108 · printed Nov 4, 2026
Cite this page
510(k) Report. “K160108: Synapse PACS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K160108
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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