510(k) · Cleared
ClearedSyMRI
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Syntheticmr AB · LNH System, Nuclear Magnetic Resonance Imaging
Cleared on Aug 29, 2017 as substantially equivalent to K161397 (Ge Medical Systems, LLC, 2016) after a 312-day review. Its family tree reaches back 14 generations to 1997. 5 of the 32 devices in its family, counting itself, have a Class I recall.
- Decided
- Aug 29, 2017
- Review
- 312 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 14 generations to K971684 (1997). 31 ancestors in all, the oldest K962061 (1996). No later device cites it as a predicate yet. 5 of the 32 devices in this family, counting this one, have a Class I recall.
- Root · 14 generations backK971684 Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 10 generations between
- 3 generations backK132376 Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750W 3.0T…Ge Healthcare (Ge Medical Systems, LLC) · 2013 · Recalled
- 2 generations backK142085 Discovery MR750 3.0T ,Discovery MR450 1.5T, Discovery MR750…Ge Medical Systems, LLC · 2014 · Recalled
- 1 generation backK161397 MAGiCGe Medical Systems, LLC · 2016
- This deviceK162943 SyMRISyntheticmr AB · 2017
Show all 14 generations
- Root · 14 generations backK971684 Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 13 generations backK032428 Magnetom Avanto MR SystemSiemens Medical Solutions USA, Inc. · 2003 · Recalled
- 12 generations backK041112 Magnetom Espree SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 11 generations backK052164 Magnetom Systems with Software Syngo MR 2006ASiemens Medical Solutions USA, Inc. · 2005
- 10 generations backK062454 Magnetom Systems - I-Class and T-Class ReleasesSiemens Medi Cal Solutions, Inc. · 2006
- 9 generations backK072237 Magnetom VerioSiemens Medical Solutions USA, Inc. · 2007 · Recalled (Class I)
- 8 generations backK081028 Signa 3.0T MR750 SystemGe Medical Systems, LLC · 2008 · Recalled
- 7 generations backK083147 Discovery MR450Ge Medical Systems, LLC · 2008 · Recalled
- 6 generations backK091536 Optima MR450WGe Medical Systems, LLC · 2009 · Recalled
- 5 generations backK113490 Optima MR450WGe Medical Systems, LLC · 2012 · Recalled
- 4 generations backK123522 Optima MR450WGe Healthcare (Ge Medical Systems, LLC) · 2013 · Recalled
- 3 generations backK132376 Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750W 3.0T…Ge Healthcare (Ge Medical Systems, LLC) · 2013 · Recalled
- 2 generations backK142085 Discovery MR750 3.0T ,Discovery MR450 1.5T, Discovery MR750…Ge Medical Systems, LLC · 2014 · Recalled
- 1 generation backK161397 MAGiCGe Medical Systems, LLC · 2016
- This deviceK162943 SyMRISyntheticmr AB · 2017
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K971684 | Magnetom Project 047 System (Numaris 3.5 Software) | Siemens Medical Solutions USA, Inc. | 1997 | 4 |
| −13 | K032428 | Magnetom Avanto MR System | Siemens Medical Solutions USA, Inc. | 2003 | 4 |
| −12 | K041112 | Magnetom Espree System | Siemens Medical Solutions USA, Inc. | 2004 | 4 |
| −11 | K052164 | Magnetom Systems with Software Syngo MR 2006A | Siemens Medical Solutions USA, Inc. | 2005 | — |
| −10 | K062454 | Magnetom Systems - I-Class and T-Class Releases | Siemens Medi Cal Solutions, Inc. | 2006 | — |
| −9 | K072237 | Magnetom Verio | Siemens Medical Solutions USA, Inc. | 2007 | Class I |
| −8 | K081028 | Signa 3.0T MR750 System | Ge Medical Systems, LLC | 2008 | 11 |
| −7 | K083147 | Discovery MR450 | Ge Medical Systems, LLC | 2008 | 10 |
| −6 | K091536 | Optima MR450W | Ge Medical Systems, LLC | 2009 | 8 |
| −5 | K113490 | Optima MR450W | Ge Medical Systems, LLC | 2012 | 3 |
| −4 | K123522 | Optima MR450W | Ge Healthcare (Ge Medical Systems, LLC) | 2013 | 1 |
| −3 | K132376 | Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750W 3.0T, Optima… | Ge Healthcare (Ge Medical Systems, LLC) | 2013 | 15 |
| −2 | K142085 | Discovery MR750 3.0T ,Discovery MR450 1.5T, Discovery MR750 3.0T,Optima MR450W… | Ge Medical Systems, LLC | 2014 | 27 |
| −1 | K161397 | MAGiC | Ge Medical Systems, LLC | 2016 | — |
| 0 (this device) | K162943 | SyMRI | Syntheticmr AB | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2001 | 4 | 1 |
| 2002 | 2 | 1 |
| 2003 | 1 | 1 |
| 2004 | 1 | 1 |
| 2005 | 3 | 0 |
| 2011 | 1 | 0 |
| 2013 | 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.
5 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? (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 |
|---|---|---|---|
| * | K161397 | MAGiCSummary page 4…me: SyMRI® 10 Common Name: Nuclear Magnetic Resonance Imaging System Classification: 21CFR 892.1000 Product Code: LNH Regulatory Class: II Predicate Device: MAGiC K161397 (LNH) Indications for Use SyMRI is a post-processing software medical device intended for use in visualization of the brain. Sy… | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (5 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.
- K072237Magnetom VerioSiemens Medical Solutions USA, Inc. · 2007 · 7 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K041476GE Signa Excite 1.5T MR System, GE Signa Excite 3.0T MR SystemGe Medical Systems, LLC · 2004 · 8 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 · 9 generations back · ◆ in the 2003 ancestors bar of FIG. 11 Class I recall
- K013636Signa Infinity MR System with Excite TechnologyGE Medical Systems · 2002 · 9 generations back · ◆ in the 2002 ancestors bar of FIG. 11 Class I recall
- K0122001.5T Infinity Twinspeed MR SystemGE Medical Systems · 2001 · 10 generations back · ◆ in the 2001 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 20 years and passes through 5 companies; a new generation was cleared every 12 months on median.
- 23 of the 31 ancestors have a recall of any class; 5 have 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. 2017, 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?
SyMRI is a post-processing software medical device intended for use in visualization of the brain. SyMRI analyzes input data from MR imaging systems. SyMRI utilizes data from a multi-delay, multi-echo acquisition (MDME) to generate parametric maps of R1, R2 relaxation rates, and proton density (PD). SyMRI can generate multiple image contrasts from the parametric maps. SyMRI enables post-acquisition image contrast adjustment. SyMRI is indicated for head imaging. When interpreted by a trained physician, SyMRI images can provide information useful in determining diagnosis. SyMRI should always be used in combination with at least one other, conventional MR acquisition (e.g. T2-FLAIR).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162943 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162943: SyMRI.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162943
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