510(k) · Cleared
Recalled · Class II · 2026Synapse PACS
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fujifilm Corporation · LLZ System, Image Processing, Radiological
Cleared on Mar 26, 2019 as substantially equivalent to K160108 (Fujifilm Medical Systems U.S.A, Inc., 2016) and 1 other predicate after a 48-day review. Its family tree reaches back 12 generations to 1991. 3 later devices descend from it. It has been recalled 11 times.
- Decided
- Mar 26, 2019
- Review
- 48 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- 11
- Predicates
- 2
Its longest line of descent runs back 12 generations to K913770 (1991). 113 ancestors in all, the oldest K871859 (1987). 3 later devices descend from it, 2 citing it directly.
- Root · 12 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 8 generations between
- 3 generations backK101228 Mirada XDMirada Medical, Ltd. · 2010
- 2 generations backK113244 Synapse MPR FusionFujifilm Medical System U.S.A., Inc. · 2011
- 1 generation backK160108 Synapse PACSFujifilm Medical Systems U.S.A, Inc. · 2016 · Recalled
- This deviceK190232 Synapse PACSFujifilm Corporation · 2019
- Descendant · cites it directly · 1 of its ownK243647 Synapse PACS (7.5)FUJIFILM Healthcare Americas Corporation · 2025
- Descendant · 2 generations on · 0 of its ownK261713 Synapse PACS (7.6.0)FUJIFILM Healthcare Americas Corporation · 2026
- Descendant · cites it directly · 0 of its ownK192508 Medsynapse Ris Pacs & Medsynapse VNAMedsynaptic Private, Ltd. · 2019
Show all 12 generations
- Root · 12 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 11 generations backK963345 Advantage Windows Tissue Volume OptionGE Medical Systems · 1996
- 10 generations backK013381 Advanced Lung Analysis-1General Electric Co. · 2001
- 9 generations backK022013 Lungcare CT Software PackageSiemens Medical Solutions USA, Inc. · 2002
- 8 generations backK033374 Lungcare CT Software Package with Extended FunctionalitySiemens AG Medical Solutions · 2003
- 7 generations backK041484 UndecidedSiemens Medical Solutions USA, Inc. · 2004
- 6 generations backK053301 Cedara I-Response Cedara Pet/CTCedara Software Corp. · 2006
- 5 generations backK071950 Syngo TruedSiemens Medical Solutions USA, Inc. · 2007
- 4 generations backK091373 Syngo TruedSiemens Medical Solutions USA, Inc. · 2009
- 3 generations backK101228 Mirada XDMirada Medical, Ltd. · 2010
- 2 generations backK113244 Synapse MPR FusionFujifilm Medical System U.S.A., Inc. · 2011
- 1 generation backK160108 Synapse PACSFujifilm Medical Systems U.S.A, Inc. · 2016 · Recalled
- This deviceK190232 Synapse PACSFujifilm Corporation · 2019
Most influential descendants
Showing 3 of 3 · See all- K243647Synapse PACS (7.5)FUJIFILM Healthcare Americas Corporation · 2025 · cites it directly1descendant
- K261713Synapse PACS (7.6.0)FUJIFILM Healthcare Americas Corporation · 2026 · 2 generations on0descendants
- K192508Medsynapse Ris Pacs & Medsynapse VNAMedsynaptic Private, Ltd. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −11 | K963345 | Advantage Windows Tissue Volume Option | GE Medical Systems | 1996 | — |
| −10 | K013381 | Advanced Lung Analysis-1 | General Electric Co. | 2001 | — |
| −9 | K022013 | Lungcare CT Software Package | Siemens Medical Solutions USA, Inc. | 2002 | — |
| −8 | K033374 | Lungcare CT Software Package with Extended Functionality | Siemens AG Medical Solutions | 2003 | — |
| −7 | K041484 | Undecided | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −6 | K053301 | Cedara I-Response Cedara Pet/CT | Cedara Software Corp. | 2006 | — |
| −5 | K071950 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −4 | K091373 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2009 | — |
| −3 | K101228 | Mirada XD | Mirada Medical, Ltd. | 2010 | — |
| −2 | K113244 | Synapse MPR Fusion | Fujifilm Medical System U.S.A., Inc. | 2011 | — |
| −1 | K160108 | Synapse PACS | Fujifilm Medical Systems U.S.A, Inc. | 2016 | 4 |
| 0 (this device) | K190232 | Synapse PACS | Fujifilm Corporation | 2019 | — |
| +1 | K243647 | Synapse PACS (7.5) | FUJIFILM Healthcare Americas Corporation | 2025 | — |
| +2 | K261713 | Synapse PACS (7.6.0) | FUJIFILM Healthcare Americas Corporation | 2026 | — |
| +1 | 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 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 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 21.6 · 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 |
|---|---|---|---|
| * | K160108 | Synapse PACSSummary page 4…Name: Picture archiving and communications system Regulation Number: 892.2050 Product Code: LLZ 5c) Predicate Devices Primary predicate K160108 - FUJIFILM Medical Systems U.S.A., Inc. - Synapse PACS Secondary predicate K151859 - FUJIFILM Medical Systems U.S.A., Inc. - Syna… | 2016 |
| * | K151859 | Synapse CardiovascularSummary page 4…892.2050 Product Code: LLZ 5c) Predicate Devices Primary predicate K160108 - FUJIFILM Medical Systems U.S.A., Inc. - Synapse PACS Secondary predicate K151859 - FUJIFILM Medical Systems U.S.A., Inc. - Synapse Cardiovascular No reference devices were used in this submission.… | 2015 |
What descends from it? (3)
2 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 |
|---|---|---|---|---|
| Jul 22, 2026 | Class II | Z-3030-2026 | Software design | Software issue may cause the ruler measurement to be inaccurate. |
| 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. |
| Jan 10, 2024 | Class II | Z-1272-2024 | Software design | Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM header, when combined with a Breast Tomo Series results in incorrect measurements. |
| Jan 10, 2024 | Class II | Z-1271-2024 | Software design | Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM header, when combined with a Breast Tomo Series results in incorrect measurements. |
| Jan 10, 2024 | Class II | Z-1268-2024 | Software design | Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM header, when combined with a Breast Tomo Series results in incorrect measurements. |
| Jan 10, 2024 | Class II | Z-1270-2024 | Software design | Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM header, when combined with a Breast Tomo Series results in incorrect measurements. |
| Jan 10, 2024 | Class II | Z-1269-2024 | Software design | Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM header, when combined with a Breast Tomo Series results in incorrect measurements. |
| Jan 10, 2024 | Class II | Z-1273-2024 | Software design | Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM header, when combined with a Breast Tomo Series results in incorrect measurements. |
| Jan 3, 2024 | Class II | Z-1171-2024 | Software design | The LV Mass (2D Bullet) equation may be calculated incorrectly, resulting in a variance in the mass of the left ventricle (LV Mass). If used as a main factor for diagnosis, there is a risk of misdiagnosis or incorrect treatment plan of a… |
| Dec 11, 2020 | Class II | Z-0918-2021 | Software change control | The software does not update measurements and calculations in the Clinical Reporting Application (CRA) when the ventricular trace is changed in the study by a different user. |
| Sep 11, 2020 | Class II | Z-0282-2021 | Software change control | FUJIFILM has become aware of the possibility that certain CT studies may report a much higher 3D Sphere MAX value than expected. This issue is specific to 3D Sphere - other density tools are not affected. |
The 5 latest of 11 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 28 years and passes through 9 companies; a new generation was cleared every 1.5 years on median.
- 29 of the 113 ancestors have a recall of any class.
- Of its descendants, K243647 (FUJIFILM Healthcare Americas Corporation, 2025) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K160108.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 is intended for use as a web based application on an off-the shelf PC which meets or exceeds minimum specifications and is networked with a FUJIFILM Synapse PACS server. The FUJIFILM Synapse PACS Software can process medical images from DICOM compliant modalities and non-DICOM sources. The FUJIFILM Synapse PACS Software provides toolsets for performing measurements on DICOM images, importing and presenting data from…
Read the full statement (200 words)
FUJIFILM Synapse PACS Software is intended for use as a web based application on an off-the shelf PC which meets or exceeds minimum specifications and is networked with a FUJIFILM Synapse PACS server.
The FUJIFILM Synapse PACS Software can process medical images from DICOM compliant modalities and non-DICOM sources.
The FUJIFILM Synapse PACS Software provides toolsets for performing measurements on DICOM images, importing and presenting data from modalities (DICOM and non-DICOM), solving clinical calculations, and creating and distributing structured reports.
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. It enables the display, comparison and fusion of 3D (MIP/MPR) of CT, MR, PET and SPECT studies.
Typical users are radiologists, cardiologists, technologists, sonographers, technicians, nurses and clinicians.
MIP, MPR, and 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/K190232 · printed Nov 3, 2026
Cite this page
510(k) Report. “K190232: Synapse PACS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K190232
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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