510(k) · Cleared
ClearedBrainstat Software Option for GE Signa MR Scanner
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Medical Systems, LLC · LNH System, Nuclear Magnetic Resonance Imaging
Cleared on Jan 4, 2008 as substantially equivalent to K061429 (Esaote, S.p.A., 2006) after a 56-day review. Its family tree reaches back 9 generations to 1991. 6 later devices descend from it.
- Decided
- Jan 4, 2008
- Review
- 56 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K911667 (1991). 37 ancestors in all. 6 later devices descend from it, 1 citing it directly.
- Root · 9 generations backK911667 Hitachi MRP-7000 Magnetic Rosonance DeviceHitachi Medical Systems America, Inc. · 1991 · Recalled
- 5 generations between
- 3 generations backK042236 G-SCANEsaote, S.p.A. · 2004
- 2 generations backK060956 G-Scan-Model 9800020000, E-Scan Model 9800010000 and E-Scan…Esaote, S.p.A. · 2006
- 1 generation backK061429 Dynamic Mri Software Option for C-Scan, E-Scan XQ and E-Scan OperaEsaote, S.p.A. · 2006
- This deviceK073167 Brainstat Software Option for GE Signa MR ScannerGe Medical Systems, LLC · 2008
- Descendant · cites it directly · 5 of its ownK080762 IB Neuro, Version 1.0Imaging Biometrics, LLC · 2008
- Descendant · 2 generations on · 1 of its ownK123302 IB ClinicImaging Biometrics, LLC · 2013
- Descendant · 2 generations on · 1 of its ownK120637 Synapse 3D Brain PerfusionFujifilm Medical System U.S.A., Inc. · 2012
- Descendant · 3 generations on · 0 of its ownK211356 GIQuantMotilent, Ltd. · 2021
- Descendant · 3 generations on · 0 of its ownK162287 Synapse 3D Perfusion AnalysisFujifilm Medical Systems U.S.A, Inc. · 2017
Show all 9 generations
- Root · 9 generations backK911667 Hitachi MRP-7000 Magnetic Rosonance DeviceHitachi Medical Systems America, Inc. · 1991 · Recalled
- 8 generations backK963262 Artoscan MBiosound, Inc. · 1997
- 7 generations backK981358 Artoscan SBiosound Esaote, Inc. · 1998
- 6 generations backK990968 E-SCANBiosound Esaote, Inc. · 1999
- 5 generations backK020164 E-Scan XQBiosound Esaote, Inc. · 2002
- 4 generations backK032121 Modification to E-Scan XQEsaote, S.p.A. · 2003
- 3 generations backK042236 G-SCANEsaote, S.p.A. · 2004
- 2 generations backK060956 G-Scan-Model 9800020000, E-Scan Model 9800010000 and E-Scan…Esaote, S.p.A. · 2006
- 1 generation backK061429 Dynamic Mri Software Option for C-Scan, E-Scan XQ and E-Scan OperaEsaote, S.p.A. · 2006
- This deviceK073167 Brainstat Software Option for GE Signa MR ScannerGe Medical Systems, LLC · 2008
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K080762IB Neuro, Version 1.0Imaging Biometrics, LLC · 2008 · cites it directly5descendants
- K123302IB ClinicImaging Biometrics, LLC · 2013 · 2 generations on1descendant
- K120637Synapse 3D Brain PerfusionFujifilm Medical System U.S.A., Inc. · 2012 · 2 generations on1descendant
- K211356GIQuantMotilent, Ltd. · 2021 · 3 generations on0descendants
- K162287Synapse 3D Perfusion AnalysisFujifilm Medical Systems U.S.A, Inc. · 2017 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K911667 | Hitachi MRP-7000 Magnetic Rosonance Device | Hitachi Medical Systems America, Inc. | 1991 | 2 |
| −8 | K963262 | Artoscan M | Biosound, Inc. | 1997 | — |
| −7 | K981358 | Artoscan S | Biosound Esaote, Inc. | 1998 | — |
| −6 | K990968 | E-SCAN | Biosound Esaote, Inc. | 1999 | — |
| −5 | K020164 | E-Scan XQ | Biosound Esaote, Inc. | 2002 | — |
| −4 | K032121 | Modification to E-Scan XQ | Esaote, S.p.A. | 2003 | — |
| −3 | K042236 | G-SCAN | Esaote, S.p.A. | 2004 | — |
| −2 | K060956 | G-Scan-Model 9800020000, E-Scan Model 9800010000 and E-Scan… | Esaote, S.p.A. | 2006 | — |
| −1 | K061429 | Dynamic Mri Software Option for C-Scan, E-Scan XQ and E-Scan Opera | Esaote, S.p.A. | 2006 | — |
| 0 (this device) | 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 | — |
| +2 | K123302 | IB Clinic | Imaging Biometrics, LLC | 2013 | — |
| +2 | K120637 | Synapse 3D Brain Perfusion | Fujifilm Medical System U.S.A., Inc. | 2012 | — |
| +3 | K211356 | GIQuant | Motilent, Ltd. | 2021 | — |
| +3 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2017 | 1 | 0 |
| 2021 | 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 LNH? 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 LNH device
- #1 K213693 MAGNETOM Vida with syngo MR XA50Ascore 23.0 · 18 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 |
|---|---|---|---|
| * | K061429 | Dynamic Mri Software Option for C-Scan, E-Scan XQ and E-Scan OperaSummary page 1…(21 CFR 892.1000, Product Code LNH) Predicate Device(s): Esaote S.p.A. Dynamic MRI Software Option for C-scan, E-scan XQ and E-scan Opera - K061429 Device Description: The BrainStat Software Option is a software application to be used on GE Signa MR scanners. it is an… | 2006 |
| † | K052293 | GE 1.5T and 3.0T Signa HDX MR System | 2005 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K080762 | IB Neuro, Version 1.0 | 2008 | 5 |
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 17 years and passes through 5 companies; a new generation was cleared every 1.4 years on median.
- 7 of the 37 ancestors have a recall of any class.
- Of its descendants, K080762 (Imaging Biometrics, LLC, 2008) has gone furthest, with 5 descendants of its own.
- 2 other devices also cite its predicate K061429.
How does its category compare?
All LNH devicesLNH System, Nuclear Magnetic Resonance Imaging: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · LNH
26in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LNH
122in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LNH
8in 2025
Class I (8 since 2007) Class II/III not classified
Adverse event reports per year · LNH
1,263in 2025
MAUDE reports naming product code LNH, 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 | 12 | 35 | 25 | 114 |
| 2008 | 19 | 53 | 12 | 167 |
| 2009 | 17 | 70 | 7 | 194 |
| 2010 | 12 | 94 | 17 | 165 |
| 2011 | 16 | 81 | 11 | 182 |
| 2012 | 22 | 89 | 5 | 170 |
| 2013 | 19 | 108 | 2 | 107 |
| 2014 | 17 | 108 | 13 | 119 |
| 2015 | 19 | 140 | 12 (2) | 113 |
| 2016 | 20 | 108 | 1 | 135 |
| 2017 | 18 | 98 | 0 | 121 |
| 2018 | 29 | 128 | 71 | 158 |
| 2019 | 26 | 62 | 5 | 158 |
| 2020 | 32 | 121 | 4 | 98 |
| 2021 | 27 | 87 | 41 | 84 |
| 2022 | 30 | 74 | 13 | 138 |
| 2023 | 30 | 124 | 10 (1) | 159 |
| 2024 | 26 | 104 | 4 | 281 |
| 2025 | 26 | 122 | 8 (5) | 1,263 |
| 2026 | 24 | 126 | 43 | — |
What is it indicated for?
BrainStat is an automated post-processing software option that is designed to process a time-series of MR images acquired in the brain. BrainStat is indicated for use on dynamic magnetic resonance imaging data sets to depict parametric images that are calculated from the image intensity variations over time. These parametric images include the integrated-area of the signal intensity change, the time from the beginning of the change of intensity to the end of the intensity change, and the ratio of the integrated area to the time.
BrainStat provides information that when interpreted by a trained physician, can be useful in determining a diagnosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073167 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073167: Brainstat Software Option for GE Signa MR Scanner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073167
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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