510(k) · Cleared
ClearedSynapse MPR Fusion
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fujifilm Medical System U.S.A., Inc. · LLZ System, Image Processing, Radiological
Cleared on Dec 22, 2011 as substantially equivalent to K101228 (Mirada Medical, Ltd., 2010) after a 50-day review. Its family tree reaches back 10 generations to 1991. 9 later devices descend from it.
- Decided
- Dec 22, 2011
- Review
- 50 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K913770 (1991). 107 ancestors in all, the oldest K871859 (1987). 9 later devices descend from it, 1 citing it directly.
- Root · 10 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 6 generations between
- 3 generations backK071950 Syngo TruedSiemens Medical Solutions USA, Inc. · 2007
- 2 generations backK091373 Syngo TruedSiemens Medical Solutions USA, Inc. · 2009
- 1 generation backK101228 Mirada XDMirada Medical, Ltd. · 2010
- This deviceK113244 Synapse MPR FusionFujifilm Medical System U.S.A., Inc. · 2011
- Descendant · cites it directly · 8 of its ownK160108 Synapse PACSFujifilm Medical Systems U.S.A, Inc. · 2016 · Recalled
- Descendant · 2 generations on · 3 of its ownK190232 Synapse PACSFujifilm Corporation · 2019 · Recalled
- Descendant · 3 generations on · 1 of its ownK243647 Synapse PACS (7.5)FUJIFILM Healthcare Americas Corporation · 2025
- Descendant · 2 generations on · 1 of its ownK173475 Merge PACSMerge Healthcare Incorporated · 2017 · Recalled
- Descendant · 4 generations on · 0 of its ownK261713 Synapse PACS (7.6.0)FUJIFILM Healthcare Americas Corporation · 2026
Show all 10 generations
- Root · 10 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 9 generations backK963345 Advantage Windows Tissue Volume OptionGE Medical Systems · 1996
- 8 generations backK013381 Advanced Lung Analysis-1General Electric Co. · 2001
- 7 generations backK022013 Lungcare CT Software PackageSiemens Medical Solutions USA, Inc. · 2002
- 6 generations backK033374 Lungcare CT Software Package with Extended FunctionalitySiemens AG Medical Solutions · 2003
- 5 generations backK041484 UndecidedSiemens Medical Solutions USA, Inc. · 2004
- 4 generations backK053301 Cedara I-Response Cedara Pet/CTCedara Software Corp. · 2006
- 3 generations backK071950 Syngo TruedSiemens Medical Solutions USA, Inc. · 2007
- 2 generations backK091373 Syngo TruedSiemens Medical Solutions USA, Inc. · 2009
- 1 generation backK101228 Mirada XDMirada Medical, Ltd. · 2010
- This deviceK113244 Synapse MPR FusionFujifilm Medical System U.S.A., Inc. · 2011
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · 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
- K261713Synapse PACS (7.6.0)FUJIFILM Healthcare Americas Corporation · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −9 | K963345 | Advantage Windows Tissue Volume Option | GE Medical Systems | 1996 | — |
| −8 | K013381 | Advanced Lung Analysis-1 | General Electric Co. | 2001 | — |
| −7 | K022013 | Lungcare CT Software Package | Siemens Medical Solutions USA, Inc. | 2002 | — |
| −6 | K033374 | Lungcare CT Software Package with Extended Functionality | Siemens AG Medical Solutions | 2003 | — |
| −5 | K041484 | Undecided | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −4 | K053301 | Cedara I-Response Cedara Pet/CT | Cedara Software Corp. | 2006 | — |
| −3 | K071950 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −2 | K091373 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2009 | — |
| −1 | K101228 | Mirada XD | Mirada Medical, Ltd. | 2010 | — |
| 0 (this device) | 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 |
| +2 | K190232 | Synapse PACS | Fujifilm Corporation | 2019 | 11 |
| +3 | K243647 | Synapse PACS (7.5) | FUJIFILM Healthcare Americas Corporation | 2025 | — |
| +2 | K173475 | Merge PACS | Merge Healthcare Incorporated | 2017 | 2 |
| +4 | K261713 | Synapse PACS (7.6.0) | FUJIFILM Healthcare Americas Corporation | 2026 | — |
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 | 4 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 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? (1)
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 |
|---|---|---|---|
| * | K101228 | Mirada XDSummary page 2…T, MR, PET and SPECT studies. Typical users are radiologists, technologists and clinicians. Synapse MPR/Fusion is not intended for Mammography use. Predicate Mirada XD (K1 01228) Indications for Use: Mirada XD is intended to be used by trained medical professionals including, but not limited… | 2010 |
What descends from it? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K160108 | Synapse PACS | 2016 | 8 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 7 companies; a new generation was cleared every 1.5 years on median.
- 24 of the 107 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 K101228.
How does its category compare?
All LLZ devicesLLZ 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
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?
Synapse MPR/Fusion 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.
Synapse MPR/Fusion is not intended for Mammography use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113244 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113244: Synapse MPR Fusion.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113244
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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