510(k) · Cleared
ClearedSynapse 3D Brain Perfusion
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 May 8, 2012 as substantially equivalent to K103687 (Fujifilm Medical System U.S.A., Inc., 2011) and 1 other predicate after a 68-day review. Its family tree reaches back 11 generations to 1991. 1 later device descends from it.
- Decided
- May 8, 2012
- Review
- 68 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 11 generations to K911667 (1991). 40 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 11 generations backK911667 Hitachi MRP-7000 Magnetic Rosonance DeviceHitachi Medical Systems America, Inc. · 1991 · Recalled
- 7 generations between
- 3 generations backK061429 Dynamic Mri Software Option for C-Scan, E-Scan XQ and E-Scan OperaEsaote, S.p.A. · 2006
- 2 generations backK073167 Brainstat Software Option for GE Signa MR ScannerGe Medical Systems, LLC · 2008
- 1 generation backK080762 IB Neuro, Version 1.0Imaging Biometrics, LLC · 2008
- This deviceK120637 Synapse 3D Brain PerfusionFujifilm Medical System U.S.A., Inc. · 2012
- Descendant · cites it directly · 0 of its ownK162287 Synapse 3D Perfusion AnalysisFujifilm Medical Systems U.S.A, Inc. · 2017
Show all 11 generations
- Root · 11 generations backK911667 Hitachi MRP-7000 Magnetic Rosonance DeviceHitachi Medical Systems America, Inc. · 1991 · Recalled
- 10 generations backK963262 Artoscan MBiosound, Inc. · 1997
- 9 generations backK981358 Artoscan SBiosound Esaote, Inc. · 1998
- 8 generations backK990968 E-SCANBiosound Esaote, Inc. · 1999
- 7 generations backK020164 E-Scan XQBiosound Esaote, Inc. · 2002
- 6 generations backK032121 Modification to E-Scan XQEsaote, S.p.A. · 2003
- 5 generations backK042236 G-SCANEsaote, S.p.A. · 2004
- 4 generations backK060956 G-Scan-Model 9800020000, E-Scan Model 9800010000 and E-Scan…Esaote, S.p.A. · 2006
- 3 generations backK061429 Dynamic Mri Software Option for C-Scan, E-Scan XQ and E-Scan OperaEsaote, S.p.A. · 2006
- 2 generations backK073167 Brainstat Software Option for GE Signa MR ScannerGe Medical Systems, LLC · 2008
- 1 generation backK080762 IB Neuro, Version 1.0Imaging Biometrics, LLC · 2008
- This deviceK120637 Synapse 3D Brain PerfusionFujifilm Medical System U.S.A., Inc. · 2012
Most influential descendants
Showing 1 of 1 · See all- K162287Synapse 3D Perfusion AnalysisFujifilm Medical Systems U.S.A, Inc. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K911667 | Hitachi MRP-7000 Magnetic Rosonance Device | Hitachi Medical Systems America, Inc. | 1991 | 2 |
| −10 | K963262 | Artoscan M | Biosound, Inc. | 1997 | — |
| −9 | K981358 | Artoscan S | Biosound Esaote, Inc. | 1998 | — |
| −8 | K990968 | E-SCAN | Biosound Esaote, Inc. | 1999 | — |
| −7 | K020164 | E-Scan XQ | Biosound Esaote, Inc. | 2002 | — |
| −6 | K032121 | Modification to E-Scan XQ | Esaote, S.p.A. | 2003 | — |
| −5 | K042236 | G-SCAN | Esaote, S.p.A. | 2004 | — |
| −4 | K060956 | G-Scan-Model 9800020000, E-Scan Model 9800010000 and E-Scan… | Esaote, S.p.A. | 2006 | — |
| −3 | K061429 | Dynamic Mri Software Option for C-Scan, E-Scan XQ and E-Scan Opera | Esaote, S.p.A. | 2006 | — |
| −2 | K073167 | Brainstat Software Option for GE Signa MR Scanner | Ge Medical Systems, LLC | 2008 | — |
| −1 | K080762 | IB Neuro, Version 1.0 | Imaging Biometrics, LLC | 2008 | — |
| 0 (this device) | K120637 | Synapse 3D Brain Perfusion | Fujifilm Medical System U.S.A., Inc. | 2012 | — |
| +1 | 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 |
|---|---|---|
| 1991 | 4 | 0 |
| 1992 | 2 | 0 |
| 1993 | 4 | 0 |
| 1994 | 4 | 0 |
| 1995 | 3 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 3 | 0 |
| 2004 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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 |
|---|---|---|---|
| * | K103687 | Synapse 3D Cerebral AnalysisSummary page 2…FILM Medical Systems U.S.A., Inc. Synapse 3D Brain Perfusion (V3.0) 510(k) Predicate Device: *Synapse 3D Cerebral Analysis, FUJIFILM Medical Systems U.S.A., Inc. (K1 03687) * B Neuro vi .0, Imaging Biometrics, LLC (K080762) Description of the Device. Synapse 3D Brain Perfusion (V3.0) is the u… | 2011 |
| * | K080762 | IB Neuro, Version 1.0Summary page 2…on (V3.0) 510(k) Predicate Device: *Synapse 3D Cerebral Analysis, FUJIFILM Medical Systems U.S.A., Inc. (K1 03687) * B Neuro vi .0, Imaging Biometrics, LLC (K080762) Description of the Device. Synapse 3D Brain Perfusion (V3.0) is the updated version of previously-cleared Synapse 3D Cerebral… | 2008 |
| † | K103465 | Synapse 3D Cardiac Tools | 2011 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K162287 | Synapse 3D Perfusion Analysis | 2017 | 0 |
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 21 years and passes through 7 companies; a new generation was cleared every 1.4 years on median.
- 7 of the 40 ancestors have a recall of any class.
- Of its descendants, K162287 (Fujifilm Medical Systems U.S.A, Inc., 2017) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 Brain Perfusion 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 Brain Perfusion accepts DICOM conmpliant 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…
Read the full statement (125 words)
Synapse 3D Brain Perfusion 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 Brain Perfusion accepts DICOM conmpliant 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 Brain Perfusion provides the parameter images by post-processing with dynamic scanned CT cerebral arteriography images and magnetic resonance images (MR) with contrast agent to aid the assessment of cerebral blood flow. The parameter images are Cerebral Blood Volume (CBV), Cerebral Bbood Flow (CBF), Mean Transit Time (MUT), and Time To Peak (UTP).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120637 · printed Nov 5, 2026
Cite this page
510(k) Report. “K120637: Synapse 3D Brain Perfusion.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K120637
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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