510(k) · Cleared
ClearedSWIP
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems Nederland B.V. · LNH System, Nuclear Magnetic Resonance Imaging
Cleared on Aug 30, 2013 as substantially equivalent to K110151 (Philips Health Care, 2011) and 2 other predicates after a 121-day review. Its family tree reaches back 8 generations to 1997. 9 of the 37 devices in its family, counting itself, have a Class I recall. 5 later devices descend from it.
- Decided
- Aug 30, 2013
- Review
- 121 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K971684 (1997). 31 ancestors in all, the oldest K962061 (1996). 5 later devices descend from it, 2 citing it directly. 9 of the 37 devices in this family, counting this one, have a Class I recall.
- Root · 8 generations backK971684 Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 7 generations backK032428 Magnetom Avanto MR SystemSiemens Medical Solutions USA, Inc. · 2003 · Recalled
- 6 generations backK041112 Magnetom Espree SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 5 generations backK052164 Magnetom Systems with Software Syngo MR 2006ASiemens Medical Solutions USA, Inc. · 2005
- 4 generations backK062454 Magnetom Systems - I-Class and T-Class ReleasesSiemens Medi Cal Solutions, Inc. · 2006
- 3 generations backK072237 Magnetom VerioSiemens Medical Solutions USA, Inc. · 2007 · Recalled (Class I)
- 2 generations backK081028 Signa 3.0T MR750 SystemGe Medical Systems, LLC · 2008 · Recalled
- 1 generation backK083147 Discovery MR450Ge Medical Systems, LLC · 2008 · Recalled
- This deviceK131241 SWIPPhilips Medical Systems Nederland B.V. · 2013
- Descendant · cites it directly · 3 of its ownK173224 Spin-SwiSpintech, Inc. · 2018
- Descendant · 2 generations on · 1 of its ownK210843 STAGESpintech, Inc. · 2021
- Descendant · 3 generations on · 0 of its ownK223079 StageSpintech, Inc. · 2022
- Descendant · 2 generations on · 0 of its ownK203279 Veuron-Brain-mN1Heuron Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK210415 QSM software, QSMetricMedimagemetric, LLC · 2021
Class I recalls in this family
Most influential descendants
Showing 5 of 5 · See all- K173224Spin-SwiSpintech, Inc. · 2018 · cites it directly3descendants
- K210843STAGESpintech, Inc. · 2021 · 2 generations on1descendant
- K223079StageSpintech, Inc. · 2022 · 3 generations on0descendants
- K203279Veuron-Brain-mN1Heuron Co., Ltd. · 2022 · 2 generations on0descendants
- K210415QSM software, QSMetricMedimagemetric, LLC · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K971684 | Magnetom Project 047 System (Numaris 3.5 Software) | Siemens Medical Solutions USA, Inc. | 1997 | 4 |
| −7 | K032428 | Magnetom Avanto MR System | Siemens Medical Solutions USA, Inc. | 2003 | 4 |
| −6 | K041112 | Magnetom Espree System | Siemens Medical Solutions USA, Inc. | 2004 | 4 |
| −5 | K052164 | Magnetom Systems with Software Syngo MR 2006A | Siemens Medical Solutions USA, Inc. | 2005 | — |
| −4 | K062454 | Magnetom Systems - I-Class and T-Class Releases | Siemens Medi Cal Solutions, Inc. | 2006 | — |
| −3 | K072237 | Magnetom Verio | Siemens Medical Solutions USA, Inc. | 2007 | Class I |
| −2 | K081028 | Signa 3.0T MR750 System | Ge Medical Systems, LLC | 2008 | 11 |
| −1 | K083147 | Discovery MR450 | Ge Medical Systems, LLC | 2008 | 10 |
| 0 (this device) | K131241 | SWIP | Philips Medical Systems Nederland B.V. | 2013 | — |
| +1 | K173224 | Spin-Swi | Spintech, Inc. | 2018 | — |
| +2 | K210843 | STAGE | Spintech, Inc. | 2021 | — |
| +3 | K223079 | Stage | Spintech, Inc. | 2022 | — |
| +2 | K203279 | Veuron-Brain-mN1 | Heuron Co., Ltd. | 2022 | — |
| +1 | K210415 | QSM software, QSMetric | Medimagemetric, LLC | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 5 | 1 |
| 2002 | 2 | 1 |
| 2003 | 2 | 1 |
| 2004 | 2 | 2 |
| 2005 | 5 | 2 |
| 2007 | 1 | 1 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 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.
9 devices in this family have a Class I recall. 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 |
|---|---|---|---|
| * | K110151 | Achieva R4 1.5T and Achieva R4 3.0TSummary page 3…tware is used for the feature SWIp. The off-the-shelf software used in the basic MR system for the lngenia and Achieva 151T and 3.OT MR systems machine is cleared by K 110151. SWIp is not designed to be connected to an external network. Hardware platform description SWIp does not require any cha… | 2011 |
| * | K083147 | Discovery MR450Summary page 2…edicate Device k#: KII10151 2. Predicate Device: Discovery MR45O Manufacturer: GE H-ealthcare Predicate Device k#: K083 147 3. Predicate Device: MAGNETOM Trio a Tim System Manufacturer: Siemens Medical Solutions… | 2008 |
| * | K050200 | Magnetom Trio a Tim SystemSummary page 2…K083 147 3. Predicate Device: MAGNETOM Trio a Tim System Manufacturer: Siemens Medical Solutions Predicate Device k#: K050200 21 CFR 807.92(a)(4): Description of the device that is the subject of this premarket notification: Summary of fun… | 2005 |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (9 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K063559Achieva, Intera and Panorama 1.0T, Release 2.5Philips Medical Systems · 2007 · 2 generations back · ◆ in the 2007 ancestors bar of FIG. 11 Class I recall
- K043147Achieva FamilyPhilips Medical Systems North America Co. · 2005 · 2 generations back · ◆ in the 2005 ancestors bar of FIG. 13 Class I recalls
- K072237Magnetom VerioSiemens Medical Solutions USA, Inc. · 2007 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K052078Achieva, Intera and Panorama 1.0 Release 2-SeriesPhilips Medical Systems Nederland B.V. · 2005 · 3 generations back · ◆ in the 2005 ancestors bar of FIG. 11 Class I recall
- K041602Panorama 1.0TPhilips Medical Systems North America, Inc. · 2004 · 3 generations back · ◆ in the 2004 ancestors bar of FIG. 11 Class I recall
- K041476GE Signa Excite 1.5T MR System, GE Signa Excite 3.0T MR SystemGe Medical Systems, LLC · 2004 · 3 generations back · ◆ in the 2004 ancestors bar of FIG. 11 Class I recall
- K030874GE 3.0T Signa Infinity Twinspeed with Excite MR SystemGeneral Electric Co. · 2003 · 4 generations back · ◆ in the 2003 ancestors bar of FIG. 11 Class I recall
- K013636Signa Infinity MR System with Excite TechnologyGE Medical Systems · 2002 · 4 generations back · ◆ in the 2002 ancestors bar of FIG. 11 Class I recall
- K0122001.5T Infinity Twinspeed MR SystemGE Medical Systems · 2001 · 5 generations back · ◆ in the 2001 ancestors bar of FIG. 11 Class I recall
Nearest 5 of 9; all are on the web page.
What does this lineage say?
- The line of descent spans 16 years and passes through 4 companies; a new generation was cleared every 1.1 years on median.
- 24 of the 31 ancestors have a recall of any class; 9 have a Class I recall.
- Of its descendants, K173224 (Spintech, Inc., 2018) has gone furthest, with 3 descendants of its own.
- 7 other devices also cite its predicate K110151.
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. 2013, 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?
SWIp is a software option intended for use on Achieva and Ingenia I15T & 3.OT MR Systems. It's indicated for magnetic resonance imaging of the Brain. SWIp is a technique using phase information to enhance contrast between tissues presenting susceptibility differences, such as dleoxygenated blood or some mineral deposits (e.g. calcium deposits). Due to this contrast enhancement, SWIp images are sensitive for structures containing venous blood such as cerebral venous vasculature. When used in combination with other clinical information, SWIp may help the expert radiologist in the diagnosis of various neurological pathologies.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131241 · printed Nov 5, 2026
Cite this page
510(k) Report. “K131241: SWIP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K131241
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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