510(k) · Cleared
ClearedMR-Touch Option
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 Jul 24, 2009 as substantially equivalent to K052293 (Ge Medical Systems, LLC, 2005) and 1 other predicate after a 247-day review. Its family tree reaches back 12 generations to 1995. 4 of the 104 devices in its family, counting itself, have a Class I recall. 4 later devices descend from it.
- Decided
- Jul 24, 2009
- Review
- 247 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 12 generations to K935595 (1995). 99 ancestors in all, the oldest K891689 (1989). 4 later devices descend from it, 2 citing it directly. 4 of the 104 devices in this family, counting this one, have a Class I recall.
- Root · 12 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 8 generations between
- 3 generations backK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
- 2 generations backK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- 1 generation backK083095 Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008
- This deviceK083421 MR-Touch OptionGe Medical Systems, LLC · 2009
- Descendant · cites it directly · 2 of its ownK140666 MR ElastographyPhilips Medical Systems Nederland B.V. · 2014
- Descendant · cites it directly · 1 of its ownK201389 Resoundant Acoustic Driver SystemResoundant, Inc. · 2020
- Descendant · 2 generations on · 0 of its ownK242006 SureWave Elastography (Q7000225)Quality Electrodynamics, LLC · 2025
- Descendant · 2 generations on · 0 of its ownK220018 MR Elastography; MZEK-001ACanon Medical Systems Corporation · 2022
Show all 12 generations
- Root · 12 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 11 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 10 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 9 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 8 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 7 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 6 generations backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 5 generations backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 4 generations backK063138 Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006
- 3 generations backK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
- 2 generations backK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- 1 generation backK083095 Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008
- This deviceK083421 MR-Touch OptionGe Medical Systems, LLC · 2009
Class I recalls in this family
- K041476 GE Signa Excite 1.5T MR System, GE Signa Excite…2 generations back · 2004
- K030874 GE 3.0T Signa Infinity Twinspeed with Excite MR…3 generations back · 2003
- K013636 Signa Infinity MR System with Excite Technology3 generations back · 2002
- K012200 1.5T Infinity Twinspeed MR System4 generations back · 2001
Most influential descendants
Showing 4 of 4 · See all- K140666MR ElastographyPhilips Medical Systems Nederland B.V. · 2014 · cites it directly2descendants
- K201389Resoundant Acoustic Driver SystemResoundant, Inc. · 2020 · cites it directly1descendant
- K242006SureWave Elastography (Q7000225)Quality Electrodynamics, LLC · 2025 · 2 generations on0descendants
- K220018MR Elastography; MZEK-001ACanon Medical Systems Corporation · 2022 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −11 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −10 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −9 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −8 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −7 | K042770 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| −6 | K050240 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −5 | K052894 | Sonoline G60 S Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −4 | K063138 | Modification to Acuson Antares Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | — |
| −3 | K063803 | Acuson Antares Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | 9 |
| −2 | K072786 | Acuson S2000 Ultrasound System | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −1 | K083095 | Sonixtouch Ultrasound System | Ultrasonix Medical Corporation | 2008 | — |
| 0 (this device) | K083421 | MR-Touch Option | Ge Medical Systems, LLC | 2009 | — |
| +1 | K140666 | MR Elastography | Philips Medical Systems Nederland B.V. | 2014 | — |
| +1 | K201389 | Resoundant Acoustic Driver System | Resoundant, Inc. | 2020 | — |
| +2 | K242006 | SureWave Elastography (Q7000225) | Quality Electrodynamics, LLC | 2025 | — |
| +2 | K220018 | MR Elastography; MZEK-001A | Canon Medical Systems Corporation | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 5 | 0 |
| 1996 | 1 | 0 |
| 1997 | 6 | 0 |
| 1998 | 3 | 0 |
| 1999 | 7 | 0 |
| 2000 | 6 | 0 |
| 2001 | 9 | 1 |
| 2002 | 8 | 1 |
| 2003 | 9 | 1 |
| 2004 | 11 | 1 |
| 2005 | 9 | 0 |
| 2006 | 5 | 0 |
| 2008 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K052293 | GE 1.5T and 3.0T Signa HDX MR SystemSummary page 1…aging System Classification Name: Magnetic Resonance Diagnostic Device, (21 C.F.R. 892.1000, LNHI Predicate Devices: GE 1.5T and 3.OT Signa® H~x MR System (K052293). Ultrasonix SonixTouch Ultrasound Imaging System for Elastography 1K0830951. Device Description: MR-TouchTM isa combined softwa… | 2005 |
| * | K083095 | Sonixtouch Ultrasound SystemSummary page 1…c Device, (21 C.F.R. 892.1000, LNHI Predicate Devices: GE 1.5T and 3.OT Signa® H~x MR System (K052293). Ultrasonix SonixTouch Ultrasound Imaging System for Elastography 1K0830951. Device Description: MR-TouchTM isa combined software and hardware accessory for use wit h a GE Signa® MR System. It is an evol… | 2008 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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.
- K041476GE Signa Excite 1.5T MR System, GE Signa Excite 3.0T MR SystemGe Medical Systems, LLC · 2004 · 2 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 · 3 generations back · ◆ in the 2003 ancestors bar of FIG. 11 Class I recall
- K013636Signa Infinity MR System with Excite TechnologyGE Medical Systems · 2002 · 3 generations back · ◆ in the 2002 ancestors bar of FIG. 11 Class I recall
- K0122001.5T Infinity Twinspeed MR SystemGE Medical Systems · 2001 · 4 generations back · ◆ in the 2001 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 14 years and passes through 5 companies; a new generation was cleared every 11 months on median.
- 29 of the 99 ancestors have a recall of any class; 4 have a Class I recall.
- Of its descendants, K140666 (Philips Medical Systems Nederland B.V., 2014) has gone furthest, with 2 descendants of its own.
- 6 other devices also cite its predicate K052293.
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?
MR-TouchTM is a software and hardware option intended for use with GE Signa® MR systems. It is indicated for magnetic resonance imaging of the human body. MR-TouchTM generates transverse sectional information related to the relative stiffness of soft tissue. It consists of hardware as well as acquisition and reconstruction software. The hardware components induce vibrations into the scan subject. The MR-TouchTM acquisition software is an evolutionary…
Read the full statement (166 words)
MR-TouchTM is a software and hardware option intended for use with GE Signa® MR systems. It is indicated for magnetic resonance imaging of the human body.
MR-TouchTM generates transverse sectional information related to the relative stiffness of soft tissue. It consists of hardware as well as acquisition and reconstruction software. The hardware components induce vibrations into the scan subject. The MR-TouchTM acquisition software is an evolutionary improvement to the gradient echo sequence. The sequence synchronizes the induced vibrations to acquire a series of phase-contrast images over time. The phase-contrast imaging technique measures motion or displacement. The displacement from the induced vibrations is detected using the time-series of phase-contrast images. The displacement information is reconstructed and presented as strain wave and relative stiffness images.
When used with a GE Signa® MR system, MR-TouchTM is capable of producing transverse images of internal body structures such as muscle and liver.
When interpreted by a trained physician, these images may provide information that can be useful in determining a diagnosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083421 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083421: MR-Touch Option.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083421
Report an extraction error
Are you the manufacturer?
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