510(k) · Cleared
ClearedHyperBand
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Medical Systems, LLC · LNH System, Nuclear Magnetic Resonance Imaging
Cleared on Nov 18, 2016 as substantially equivalent to K012970 (GE Medical Systems, 2001) after an 81-day review. Its family tree reaches back 3 generations to 1996. 1 of the 9 devices in its family, counting itself, has a Class I recall.
- Decided
- Nov 18, 2016
- Review
- 81 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K962061 (1996). 8 ancestors in all. No later device cites it as a predicate yet. 1 of the 9 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK962061 Magnetic Resonance Diagnostic SystemGE Medical Systems · 1996 · Recalled
- 2 generations backK012200 1.5T Infinity Twinspeed MR SystemGE Medical Systems · 2001 · Recalled (Class I)
- 1 generation backK012970 GE Signa Asset Imaging OptionGE Medical Systems · 2001
- This deviceK162403 HyperBandGe Medical Systems, LLC · 2016
Class I recalls in this family
- K012200 1.5T Infinity Twinspeed MR System2 generations back · 2001
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K962061 | Magnetic Resonance Diagnostic System | GE Medical Systems | 1996 | 2 |
| −2 | K012200 | 1.5T Infinity Twinspeed MR System | GE Medical Systems | 2001 | Class I |
| −1 | K012970 | GE Signa Asset Imaging Option | GE Medical Systems | 2001 | — |
| 0 (this device) | K162403 | HyperBand | Ge Medical Systems, LLC | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2001 | 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.
1 device in this family has 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? (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 |
|---|---|---|---|
| * | K012970 | GE Signa Asset Imaging OptionSummary page 5…Magnetic Resonance Diagnostic Device (21 CFR 892.1000) Product Code: LNH Predicate Devices: Predicate Device: ASSET (K012970) Device Description: HyperBand is a clinical software application which is offered as an optio… | 2001 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 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.
- K0122001.5T Infinity Twinspeed MR SystemGE Medical Systems · 2001 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 20 years and passes through 2 companies; a new generation was cleared every 4.7 years on median.
- 3 of the 8 ancestors have a recall of any class; 1 has a Class I recall.
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?
HyperBand is a software option intended for use on GE MR 1.5T and 3T Systems. HyperBand consists of an acquisition and reconstruction technique allowing simultaneous excitation of multiple slices at multiple locations to accelerate imaging acquisition times or increase slice coverage without increasing scan time. HyperBand is indicated for echo-planar imaging (EPI) of the head and breast. HyperBand is indicated for imaging all patients not otherwise contraindicated for MRI examination.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162403 · printed Nov 5, 2026
Cite this page
510(k) Report. “K162403: HyperBand.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K162403
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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