510(k) · Cleared
ClearedIB Neuro, Version 1.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Imaging Biometrics, LLC · LNH System, Nuclear Magnetic Resonance Imaging
Cleared on May 15, 2008 as substantially equivalent to K073167 (Ge Medical Systems, LLC, 2008) and 2 other predicates after a 58-day review. Its family tree reaches back 10 generations to 1991. 5 later devices descend from it.
- Decided
- May 15, 2008
- Review
- 58 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 10 generations to K911667 (1991). 38 ancestors in all. 5 later devices descend from it, 3 citing it directly.
- Root · 10 generations backK911667 Hitachi MRP-7000 Magnetic Rosonance DeviceHitachi Medical Systems America, Inc. · 1991 · Recalled
- 6 generations between
- 3 generations backK060956 G-Scan-Model 9800020000, E-Scan Model 9800010000 and E-Scan…Esaote, S.p.A. · 2006
- 2 generations backK061429 Dynamic Mri Software Option for C-Scan, E-Scan XQ and E-Scan OperaEsaote, S.p.A. · 2006
- 1 generation backK073167 Brainstat Software Option for GE Signa MR ScannerGe Medical Systems, LLC · 2008
- This deviceK080762 IB Neuro, Version 1.0Imaging Biometrics, LLC · 2008
- Descendant · cites it directly · 1 of its ownK123302 IB ClinicImaging Biometrics, LLC · 2013
- Descendant · cites it directly · 1 of its ownK120637 Synapse 3D Brain PerfusionFujifilm Medical System U.S.A., Inc. · 2012
- Descendant · 2 generations on · 0 of its ownK211356 GIQuantMotilent, Ltd. · 2021
- Descendant · 2 generations on · 0 of its ownK162287 Synapse 3D Perfusion AnalysisFujifilm Medical Systems U.S.A, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK091444 PerfscapeOlea Medical · 2009
Show all 10 generations
- Root · 10 generations backK911667 Hitachi MRP-7000 Magnetic Rosonance DeviceHitachi Medical Systems America, Inc. · 1991 · Recalled
- 9 generations backK963262 Artoscan MBiosound, Inc. · 1997
- 8 generations backK981358 Artoscan SBiosound Esaote, Inc. · 1998
- 7 generations backK990968 E-SCANBiosound Esaote, Inc. · 1999
- 6 generations backK020164 E-Scan XQBiosound Esaote, Inc. · 2002
- 5 generations backK032121 Modification to E-Scan XQEsaote, S.p.A. · 2003
- 4 generations backK042236 G-SCANEsaote, S.p.A. · 2004
- 3 generations backK060956 G-Scan-Model 9800020000, E-Scan Model 9800010000 and E-Scan…Esaote, S.p.A. · 2006
- 2 generations backK061429 Dynamic Mri Software Option for C-Scan, E-Scan XQ and E-Scan OperaEsaote, S.p.A. · 2006
- 1 generation backK073167 Brainstat Software Option for GE Signa MR ScannerGe Medical Systems, LLC · 2008
- This deviceK080762 IB Neuro, Version 1.0Imaging Biometrics, LLC · 2008
Most influential descendants
Showing 5 of 5 · See all- K123302IB ClinicImaging Biometrics, LLC · 2013 · cites it directly1descendant
- K120637Synapse 3D Brain PerfusionFujifilm Medical System U.S.A., Inc. · 2012 · cites it directly1descendant
- K211356GIQuantMotilent, Ltd. · 2021 · 2 generations on0descendants
- K162287Synapse 3D Perfusion AnalysisFujifilm Medical Systems U.S.A, Inc. · 2017 · 2 generations on0descendants
- K091444PerfscapeOlea Medical · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K911667 | Hitachi MRP-7000 Magnetic Rosonance Device | Hitachi Medical Systems America, Inc. | 1991 | 2 |
| −9 | K963262 | Artoscan M | Biosound, Inc. | 1997 | — |
| −8 | K981358 | Artoscan S | Biosound Esaote, Inc. | 1998 | — |
| −7 | K990968 | E-SCAN | Biosound Esaote, Inc. | 1999 | — |
| −6 | K020164 | E-Scan XQ | Biosound Esaote, Inc. | 2002 | — |
| −5 | K032121 | Modification to E-Scan XQ | Esaote, S.p.A. | 2003 | — |
| −4 | K042236 | G-SCAN | Esaote, S.p.A. | 2004 | — |
| −3 | K060956 | G-Scan-Model 9800020000, E-Scan Model 9800010000 and E-Scan… | Esaote, S.p.A. | 2006 | — |
| −2 | K061429 | Dynamic Mri Software Option for C-Scan, E-Scan XQ and E-Scan Opera | Esaote, S.p.A. | 2006 | — |
| −1 | K073167 | Brainstat Software Option for GE Signa MR Scanner | Ge Medical Systems, LLC | 2008 | — |
| 0 (this device) | K080762 | IB Neuro, Version 1.0 | Imaging Biometrics, LLC | 2008 | — |
| +1 | K123302 | IB Clinic | Imaging Biometrics, LLC | 2013 | — |
| +1 | K120637 | Synapse 3D Brain Perfusion | Fujifilm Medical System U.S.A., Inc. | 2012 | — |
| +2 | K211356 | GIQuant | Motilent, Ltd. | 2021 | — |
| +2 | K162287 | Synapse 3D Perfusion Analysis | Fujifilm Medical Systems U.S.A, Inc. | 2017 | — |
| +1 | K091444 | Perfscape | Olea Medical | 2009 | — |
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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K073167 | Brainstat Software Option for GE Signa MR ScannerSummary page 2…llowing legally marketed devices that are currently cleared by the FDA: 510(k) Trade Name Manufacturer K073167 BrainStat Software Option for GE GE Medical Systems Signa MR Scanners 3200 N.… | 2008 |
| * | K061429 | Dynamic Mri Software Option for C-Scan, E-Scan XQ and E-Scan OperaSummary page 2…Signa MR Scanners 3200 N. Grandview Blvd. W-827 Waukesha, WI 53188 K061429 Dynamic MRI Software Option for ESAOTE S.p.A. C-Scan, E-ScanXQ and E-Scan Via Siffredi… | 2006 |
| * | K984224 | Perfusion Package for Magnetom Vision and Symphony SystemsSummary page 2…TE S.p.A. C-Scan, E-ScanXQ and E-Scan Via Siffredi, 58 Opera 16153 Genova - Italy K984224 Perfusion Package for Magnetom Siemens Medical Systems, Inc. Vision and Symphony MR Systems… | 1999 |
What descends from it? (5)
3 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)
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 6 companies; a new generation was cleared every 1.4 years on median.
- 7 of the 38 ancestors have a recall of any class.
- Of its descendants, K123302 (Imaging Biometrics, LLC, 2013) has gone furthest, with 1 descendant of its own.
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?
IB Neuro TM software allows the post-processing and display of dynamically acquired MR datasets to evaluate image intensity variations over time. lB NeuroTM vi.0 plug-in accepts data from existing MRI systems, performs quality control checks and generates parametric perfusion maps such as Relative Cerebral Blood Volume (rCBV), Cerebral Blood Flow (CBF), Mean Transit Time (MTT) and Time to Peak (TP) and sends the maps to a PACS for subsequent viewing.…
Read the full statement (111 words)
IB Neuro TM software allows the post-processing and display of dynamically acquired MR datasets to evaluate image intensity variations over time. lB NeuroTM vi.0 plug-in accepts data from existing MRI systems, performs quality control checks and generates parametric perfusion maps such as Relative Cerebral Blood Volume (rCBV), Cerebral Blood Flow (CBF), Mean Transit Time (MTT) and Time to Peak (TP) and sends the maps to a PACS for subsequent viewing. These images when interpreted by a trained physician may yield information useful in clinical applications. Our advanced technology is designed to be compliant with healthcare standards such as DICOM and is easily and rapidly integrated into existing medical image visualization applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080762 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080762: IB Neuro, Version 1.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080762
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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