510(k) · Cleared
ClearedSynapse 3D Perfusion Analysis
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 Apr 6, 2017 as substantially equivalent to K120637 (Fujifilm Medical System U.S.A., Inc., 2012) and 2 other predicates after a 234-day review. Its family tree reaches back 12 generations to 1991.
- Decided
- Apr 6, 2017
- Review
- 234 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 12 generations to K911667 (1991). 70 ancestors in all, the oldest K880965 (1988). No later device cites it as a predicate yet.
- Root · 12 generations backK911667 Hitachi MRP-7000 Magnetic Rosonance DeviceHitachi Medical Systems America, Inc. · 1991 · Recalled
- 8 generations between
- 3 generations backK073167 Brainstat Software Option for GE Signa MR ScannerGe Medical Systems, LLC · 2008
- 2 generations backK080762 IB Neuro, Version 1.0Imaging Biometrics, LLC · 2008
- 1 generation backK120637 Synapse 3D Brain PerfusionFujifilm Medical System U.S.A., Inc. · 2012
- This deviceK162287 Synapse 3D Perfusion AnalysisFujifilm Medical Systems U.S.A, Inc. · 2017
Show all 12 generations
- Root · 12 generations backK911667 Hitachi MRP-7000 Magnetic Rosonance DeviceHitachi Medical Systems America, Inc. · 1991 · Recalled
- 11 generations backK963262 Artoscan MBiosound, Inc. · 1997
- 10 generations backK981358 Artoscan SBiosound Esaote, Inc. · 1998
- 9 generations backK990968 E-SCANBiosound Esaote, Inc. · 1999
- 8 generations backK020164 E-Scan XQBiosound Esaote, Inc. · 2002
- 7 generations backK032121 Modification to E-Scan XQEsaote, S.p.A. · 2003
- 6 generations backK042236 G-SCANEsaote, S.p.A. · 2004
- 5 generations backK060956 G-Scan-Model 9800020000, E-Scan Model 9800010000 and E-Scan…Esaote, S.p.A. · 2006
- 4 generations backK061429 Dynamic Mri Software Option for C-Scan, E-Scan XQ and E-Scan OperaEsaote, S.p.A. · 2006
- 3 generations backK073167 Brainstat Software Option for GE Signa MR ScannerGe Medical Systems, LLC · 2008
- 2 generations backK080762 IB Neuro, Version 1.0Imaging Biometrics, LLC · 2008
- 1 generation backK120637 Synapse 3D Brain PerfusionFujifilm Medical System U.S.A., Inc. · 2012
- This deviceK162287 Synapse 3D Perfusion AnalysisFujifilm Medical Systems U.S.A, Inc. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K911667 | Hitachi MRP-7000 Magnetic Rosonance Device | Hitachi Medical Systems America, Inc. | 1991 | 2 |
| −11 | K963262 | Artoscan M | Biosound, Inc. | 1997 | — |
| −10 | K981358 | Artoscan S | Biosound Esaote, Inc. | 1998 | — |
| −9 | K990968 | E-SCAN | Biosound Esaote, Inc. | 1999 | — |
| −8 | K020164 | E-Scan XQ | Biosound Esaote, Inc. | 2002 | — |
| −7 | K032121 | Modification to E-Scan XQ | Esaote, S.p.A. | 2003 | — |
| −6 | K042236 | G-SCAN | Esaote, S.p.A. | 2004 | — |
| −5 | K060956 | G-Scan-Model 9800020000, E-Scan Model 9800010000 and E-Scan… | Esaote, S.p.A. | 2006 | — |
| −4 | K061429 | Dynamic Mri Software Option for C-Scan, E-Scan XQ and E-Scan Opera | Esaote, S.p.A. | 2006 | — |
| −3 | K073167 | Brainstat Software Option for GE Signa MR Scanner | Ge Medical Systems, LLC | 2008 | — |
| −2 | K080762 | IB Neuro, Version 1.0 | Imaging Biometrics, LLC | 2008 | — |
| −1 | K120637 | Synapse 3D Brain Perfusion | Fujifilm Medical System U.S.A., Inc. | 2012 | — |
| 0 (this device) | K162287 | Synapse 3D Perfusion Analysis | Fujifilm Medical Systems U.S.A, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 2 | 0 |
| 1991 | 5 | 0 |
| 1992 | 2 | 0 |
| 1993 | 4 | 0 |
| 1994 | 6 | 0 |
| 1995 | 3 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 1998 | 4 | 0 |
| 1999 | 2 | 0 |
| 2000 | 3 | 0 |
| 2001 | 6 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 3 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2015 | 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? (3)
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 |
|---|---|---|---|
| * | K120637 | Synapse 3D Brain PerfusionSummary page 4…ing, Radiological Product Code: LLZ Regulation Number: 21 CFR 892.2050 Device Class: Class II Panel: Radiology Predicate Devices: x Synapse 3D Brain Perfusion (K120637), FUJIFILM Medical Systems U.S.A., Inc. x syngo CT Myocardial Perfusion (K150713), Siemens Medical Solutions USA, Inc. x syngo… | 2012 |
| * | K150713 | syngo.CT Myocardial PerfusionSummary page 4…Class: Class II Panel: Radiology Predicate Devices: x Synapse 3D Brain Perfusion (K120637), FUJIFILM Medical Systems U.S.A., Inc. x syngo CT Myocardial Perfusion (K150713), Siemens Medical Solutions USA, Inc. x syngo Volume Perfusion-CT Body (K092013), Siemens Medical Solutions USA, Inc.… | 2015 |
| * | K092013 | Syngo Volume Perfusion-CT BodySummary page 4…usion (K120637), FUJIFILM Medical Systems U.S.A., Inc. x syngo CT Myocardial Perfusion (K150713), Siemens Medical Solutions USA, Inc. x syngo Volume Perfusion-CT Body (K092013), Siemens Medical Solutions USA, Inc. 05 - 2… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
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 26 years and passes through 8 companies; a new generation was cleared every 1.5 years on median.
- 13 of the 70 ancestors have a recall of any class.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 3D Perfusion Analysis is medical imaging software used with Synapse 3D Base Tools that is intended to provide trained medical professionals, with tools to aid them in reading, interpreting, reporting, and treatment planning. Synapse 3D Perfusion Analysis accepts DICOM compliant medical images acquired from CT and MR. This product is not intended for use with or for the primary diagnostic interpretation of Mammography images. Addition to Synapse…
Read the full statement (130 words)
Synapse 3D Perfusion Analysis is medical imaging software used with Synapse 3D Base Tools that is intended to provide trained medical professionals, with tools to aid them in reading, interpreting, reporting, and treatment planning. Synapse 3D Perfusion Analysis accepts DICOM compliant medical images acquired from CT and MR. This product is not intended for use with or for the primary diagnostic interpretation of Mammography images.
Addition to Synapse 3D Base Tools, Synapse 3D Perfusion Analysis provides the parameter images by post-processing of dynamic scanned CT arteriography and magnetic resonance (MR) images acquired with contrast agents to aid the assessment of cerebral (CT and MR), myocardial (CT) and abdomen (CT) blood flows. The parameter images are Blood Volume (BV), Blood Flow (BF), Mean Transit Time (MTT), and Time To Peak (TTP).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162287 · printed Nov 4, 2026
Cite this page
510(k) Report. “K162287: Synapse 3D Perfusion Analysis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K162287
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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