510(k) · Cleared
ClearedPerfscape
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olea Medical · LNH System, Nuclear Magnetic Resonance Imaging
Cleared on Jul 20, 2009 as substantially equivalent to K080762 (Imaging Biometrics, LLC, 2008) after a 66-day review. Its family tree reaches back 11 generations to 1991.
- Decided
- Jul 20, 2009
- Review
- 66 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K911667 (1991). 39 ancestors in all. No later device cites it as a predicate yet.
- 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 deviceK091444 PerfscapeOlea Medical · 2009
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 deviceK091444 PerfscapeOlea Medical · 2009
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) | 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 |
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 |
|---|---|---|---|
| * | K080762 | IB Neuro, Version 1.0Summary page 2…A cleared predicate device with regard to indications for use, performance and technological characteristics: 510(k) Number: K080762 Trade Name: LB NeuroTM 1.0 Manufacturer: Imaging Biometrics, LLC Classi… | 2008 |
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 18 years and passes through 7 companies; a new generation was cleared every 1.3 years on median.
- 7 of the 39 ancestors have a recall of any class.
- 2 other devices also cite its predicate K080762.
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. 2009, 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?
PERFSCAPE allows the post-processing and display of dynamically acquired Magnetic Resonance datasets to evaluate image intensity variations over time. PERFSCAPE retrieves and accepts data from existing MRI systems. Based on these data, PERFSCAPE performs quality control checks, displays Diffusion Weighted Images and generates parametric perfusion maps such as Relative Cerebral Blood Volume (rCBV), Relative Cerebral Blood Flow (rCBF), Relative Mean…
Read the full statement (118 words)
PERFSCAPE allows the post-processing and display of dynamically acquired Magnetic Resonance datasets to evaluate image intensity variations over time. PERFSCAPE retrieves and accepts data from existing MRI systems. Based on these data, PERFSCAPE performs quality control checks, displays Diffusion Weighted Images and generates parametric perfusion maps such as Relative Cerebral Blood Volume (rCBV), Relative Cerebral Blood Flow (rCBF), Relative Mean Transit Time (rMTT), Time to Peak (TTP) and Impulse Response Time to Peak (TMAX). These images when interpreted by a trained physician may yield information useful in clinical applications.
PERFSCAPE is compliant with the DICOM standard allowing the system to visualize medical images. The system is a multi-platform software running on any Windows, Mac and Linux operating systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091444 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091444: Perfscape.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091444
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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