510(k) · Cleared
ClearedMultiBand SENSE
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 Dec 30, 2016 as substantially equivalent to K143606 (Philips Medical Systems Nethrlands BV, 2015) and 1 other predicate after a 70-day review. Its family tree reaches back 6 generations to 2003. 4 of the 22 devices in its family, counting itself, have a Class I recall. 12 later devices descend from it.
- Decided
- Dec 30, 2016
- Review
- 70 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K031815 (2003). 9 ancestors in all, the oldest K001796 (2000). 12 later devices descend from it, 1 citing it directly. 4 of the 22 devices in this family, counting this one, have a Class I recall.
- Root · 6 generations backK031815 Intera-Sensation FamilyPhilips Medical Systems · 2003 · Recalled
- 5 generations backK041602 Panorama 1.0TPhilips Medical Systems North America, Inc. · 2004 · Recalled (Class I)
- 4 generations backK052078 Achieva, Intera and Panorama 1.0 Release 2-SeriesPhilips Medical Systems Nederland B.V. · 2005 · Recalled (Class I)
- 3 generations backK063559 Achieva, Intera and Panorama 1.0T, Release 2.5Philips Medical Systems · 2007 · Recalled (Class I)
- 2 generations backK110151 Achieva R4 1.5T and Achieva R4 3.0TPhilips Health Care · 2011 · Recalled
- 1 generation backK143606 MultiBand SENSEPhilips Medical Systems Nethrlands BV · 2015
- This deviceK162940 MultiBand SENSEPhilips Medical Systems Nederland B.V. · 2016
- Descendant · cites it directly · 11 of its ownK193215 Achieva, Intera, Ingenia, Ingneia CX, Ingenia Elition, and Ingenia…Philips Medical Systems Nederland B.V. · 2020 · Recalled
- Descendant · 2 generations on · 6 of its ownK212673 MR 5300Philips Medical Systems Nederland B.V. · 2021 · Recalled
- Descendant · 2 generations on · 5 of its ownK213583 Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition…Philips Medical Systems Nederland B.V. · 2022 · Recalled
- Descendant · 2 generations on · 5 of its ownK213516 Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition and MR 7700 with…Philips Medical Systems Nederland B.V. · 2022 · Recalled
- Descendant · 3 generations on · 4 of its ownK223442 MR 5300 and MR 7700 R11 MR SystemsPhilips Medical Systems Nederlands B.V. · 2022 · Recalled
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 12 · See all- K193215Achieva, Intera, Ingenia, Ingneia CX, Ingenia Elition, and Ingenia Ambition MR SystemsPhilips Medical Systems Nederland B.V. · 2020 · cites it directly11descendants
- K212673MR 5300Philips Medical Systems Nederland B.V. · 2021 · 2 generations on6descendants
- K213583Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR SystemsPhilips Medical Systems Nederland B.V. · 2022 · 2 generations on5descendants
- K213516Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition and MR 7700 with Distributed Multi NudcleiPhilips Medical Systems Nederland B.V. · 2022 · 2 generations on5descendants
- K223442MR 5300 and MR 7700 R11 MR SystemsPhilips Medical Systems Nederlands B.V. · 2022 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K031815 | Intera-Sensation Family | Philips Medical Systems | 2003 | 3 |
| −5 | K041602 | Panorama 1.0T | Philips Medical Systems North America, Inc. | 2004 | Class I |
| −4 | K052078 | Achieva, Intera and Panorama 1.0 Release 2-Series | Philips Medical Systems Nederland B.V. | 2005 | Class I |
| −3 | K063559 | Achieva, Intera and Panorama 1.0T, Release 2.5 | Philips Medical Systems | 2007 | Class I |
| −2 | K110151 | Achieva R4 1.5T and Achieva R4 3.0T | Philips Health Care | 2011 | 20 |
| −1 | K143606 | MultiBand SENSE | Philips Medical Systems Nethrlands BV | 2015 | — |
| 0 (this device) | K162940 | MultiBand SENSE | Philips Medical Systems Nederland B.V. | 2016 | — |
| +1 | K193215 | Achieva, Intera, Ingenia, Ingneia CX, Ingenia Elition, and Ingenia Ambition MR… | Philips Medical Systems Nederland B.V. | 2020 | 152 |
| +2 | K212673 | MR 5300 | Philips Medical Systems Nederland B.V. | 2021 | 17 |
| +2 | K213583 | Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems | Philips Medical Systems Nederland B.V. | 2022 | 39 |
| +2 | K213516 | Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition and MR 7700 with Distributed… | Philips Medical Systems Nederland B.V. | 2022 | 45 |
| +3 | K223442 | MR 5300 and MR 7700 R11 MR Systems | Philips Medical Systems Nederlands B.V. | 2022 | 5 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2005 | 1 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 4 | 0 |
| 2023 | 3 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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.
4 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? (2)
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 |
|---|---|---|---|
| * | K143606 | MultiBand SENSESummary page 4…er: Philips Medical Systems Nederland B.V. 510(k) Clearance: K143606, May 08, 2015 Classification Regulation: 21CFR 892.1000 Classificatio… | 2015 |
| * | K110151 | Achieva R4 1.5T and Achieva R4 3.0TSummary page 4…er: Philips Medical Systems Nederland B.V. 510(k) Clearance: K110151, March 22, 2011 Classification Regulation: 21CFR 892.1000 Classificat… | 2011 |
What descends from it? (12)
See all 121 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K193215 | Achieva, Intera, Ingenia, Ingneia CX, Ingenia Elition, and Ingenia Ambition MR Systems | 2020 | 11 |
Has anything in its family been recalled? (4 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 · ◆ on the line of descent in 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
- K052078Achieva, Intera and Panorama 1.0 Release 2-SeriesPhilips Medical Systems Nederland B.V. · 2005 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K041602Panorama 1.0TPhilips Medical Systems North America, Inc. · 2004 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 13 years and passes through 5 companies; a new generation was cleared every 1.6 years on median.
- 8 of the 9 ancestors have a recall of any class; 4 have a Class I recall.
- Of its descendants, K193215 (Philips Medical Systems Nederland B.V., 2020) has gone furthest, with 11 descendants 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. 2016, 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?
MultiBand SENSE is a software option intended for use on Ingenia 3.0T and Ingenia 3.0T CX MR Systems. It’s indicated for use in magnetic resonance imaging of the brain for BOLD fMRI and for diffusion weighted imaging. MultiBand SENSE consists of an acquisition and reconstruction technique allowing simultaneous excitation of multiple volumes to accelerate imaging acquisition times, or increasing coverage or number of diffusion directions without increasing scan time.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162940 · printed Nov 5, 2026
Cite this page
510(k) Report. “K162940: MultiBand SENSE.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K162940
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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