510(k) · Cleared
ClearedMR Permeability
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems Nederland B.V. · LLZ System, Image Processing, Radiological
Cleared on May 29, 2013 as substantially equivalent to K090546 (Nordicimaginglab AS, 2009) after a 113-day review. Its family tree reaches back 8 generations to 1990. 1 later device descends from it.
- Decided
- May 29, 2013
- Review
- 113 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K896095 (1990). 9 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 8 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 7 generations backK962699 Radworks Medical Imaging SoftwareApplicare Medical Imaging, B.V. · 1996
- 6 generations backK982862 Radworks Medical Imaging Software with Quality Control ModuleApplicare Medical Imaging, B.V. · 1998
- 5 generations backK012211 Efilm WorkstationEfilm Medical, Inc. · 2001 · Recalled
- 4 generations backK020995 Efilm Workstation with ModulesEfilm Medical, Inc. · 2002 · Recalled
- 3 generations backK063539 Nordic Image Control and Evaluation (Nice) Software, Version 2.1Nordicicemedical AS · 2007
- 2 generations backK082441 Nordicice SoftwareNordicimaginglab AS · 2008 · Recalled
- 1 generation backK090546 Modification to Nordicice SoftwareNordicimaginglab AS · 2009
- This deviceK130278 MR PermeabilityPhilips Medical Systems Nederland B.V. · 2013
- Descendant · cites it directly · 0 of its ownK143368 GenIQGe Medical Systems, LLC · 2015
Most influential descendants
Showing 1 of 1 · See all- K143368GenIQGe Medical Systems, LLC · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K896095 | Images-on-Call Teleradiology System | Devices & Services Co. | 1990 | — |
| −7 | K962699 | Radworks Medical Imaging Software | Applicare Medical Imaging, B.V. | 1996 | — |
| −6 | K982862 | Radworks Medical Imaging Software with Quality Control Module | Applicare Medical Imaging, B.V. | 1998 | — |
| −5 | K012211 | Efilm Workstation | Efilm Medical, Inc. | 2001 | 1 |
| −4 | K020995 | Efilm Workstation with Modules | Efilm Medical, Inc. | 2002 | 2 |
| −3 | K063539 | Nordic Image Control and Evaluation (Nice) Software, Version 2.1 | Nordicicemedical AS | 2007 | — |
| −2 | K082441 | Nordicice Software | Nordicimaginglab AS | 2008 | 2 |
| −1 | K090546 | Modification to Nordicice Software | Nordicimaginglab AS | 2009 | — |
| 0 (this device) | K130278 | MR Permeability | Philips Medical Systems Nederland B.V. | 2013 | — |
| +1 | K143368 | GenIQ | Ge Medical Systems, LLC | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K090546 | Modification to Nordicice SoftwareSummary page 2…quivalence is claimed: Predicate Device: nordic ICE Software Manufacturer: NordicNeuroLab Predicate Device k#: K090546 21 CEIR 807.92(a)(4): Description of the device that is the subject of this premarket notification: 1. Summar… | 2009 |
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 |
|---|---|---|---|
| K143368 | GenIQ | 2015 | 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 23 years and passes through 6 companies; a new generation was cleared every 2.8 years on median.
- 3 of the 9 ancestors have a recall of any class.
- Of its descendants, K143368 (Ge Medical Systems, LLC, 2015) has gone furthest, with 0 descendants of its own.
- 8 other devices also cite its predicate K090546.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?
MR Permeability facilitates the radiologist in visualizing and post-processing dynamic contrast-enhanced datasets. It is an optional package within IntelliSpace Portal. MR Permeability can be used by the radiologist to assess the micro-vascular properties by computing vascular permeability (Ktrans), tracer efflux rate (Kep), extravascular volume fraction (ye), plasma fraction (Vp), and Area under the curve (AUC) from Ti images of brain and prostate. The…
Read the full statement (136 words)
MR Permeability facilitates the radiologist in visualizing and post-processing dynamic contrast-enhanced datasets. It is an optional package within IntelliSpace Portal.
MR Permeability can be used by the radiologist to assess the micro-vascular properties by computing vascular permeability (Ktrans), tracer efflux rate (Kep), extravascular volume fraction (ye), plasma fraction (Vp), and Area under the curve (AUC) from Ti images of brain and prostate. The applied pharmacokinetic modeling is based on the Tofts model:
The results are presented back to the user in the form of a parametric map, a table of results and in a graph.
MR Permeability facilitates the visualization of areas with increased permeability.
MR Permeability facilitates the visualization of variations in permeability.
MR Permeability is a software tool for visualizing and post processing dynamic contrast-enhanced 3D datasets, acquired to visualize areas with abnormal vascularity.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130278 · printed Nov 4, 2026
Cite this page
510(k) Report. “K130278: MR Permeability.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K130278
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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