510(k) · Cleared
ClearedMagnetom C!
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions USA, Inc. · LNH System, Nuclear Magnetic Resonance Imaging
Cleared on Oct 1, 2008 as substantially equivalent to K071925 (Siemens Medical Solutions USA, Inc., 2007) and 1 other predicate after a 48-day review. Its family tree reaches back 6 generations to 1997. 3 later devices descend from it.
- Decided
- Oct 1, 2008
- Review
- 48 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K971684 (1997). 14 ancestors in all, the oldest K970852 (1997). 3 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK971684 Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 5 generations backK032428 Magnetom Avanto MR SystemSiemens Medical Solutions USA, Inc. · 2003 · Recalled
- 4 generations backK041112 Magnetom Espree SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 3 generations backK052164 Magnetom Systems with Software Syngo MR 2006ASiemens Medical Solutions USA, Inc. · 2005
- 2 generations backK062454 Magnetom Systems - I-Class and T-Class ReleasesSiemens Medi Cal Solutions, Inc. · 2006
- 1 generation backK071925 Magnetom EssenzaSiemens Medical Solutions USA, Inc. · 2007 · Recalled
- This deviceK082331 Magnetom C!Siemens Medical Solutions USA, Inc. · 2008
- Descendant · cites it directly · 2 of its ownK190524 MRopen 0.5 TAsg Superconductors S.P.A. · 2019
- Descendant · 2 generations on · 1 of its ownK193116 MRopen EVOAsg Superconductors S.P.A. · 2019
- Descendant · 3 generations on · 0 of its ownK242258 MROpen Evo (03-2000-00); MROpen Evo (03-4000-00)Asg Superconductors S.P.A. · 2024
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K971684 | Magnetom Project 047 System (Numaris 3.5 Software) | Siemens Medical Solutions USA, Inc. | 1997 | 4 |
| −5 | K032428 | Magnetom Avanto MR System | Siemens Medical Solutions USA, Inc. | 2003 | 4 |
| −4 | K041112 | Magnetom Espree System | Siemens Medical Solutions USA, Inc. | 2004 | 4 |
| −3 | K052164 | Magnetom Systems with Software Syngo MR 2006A | Siemens Medical Solutions USA, Inc. | 2005 | — |
| −2 | K062454 | Magnetom Systems - I-Class and T-Class Releases | Siemens Medi Cal Solutions, Inc. | 2006 | — |
| −1 | K071925 | Magnetom Essenza | Siemens Medical Solutions USA, Inc. | 2007 | 1 |
| 0 (this device) | K082331 | Magnetom C! | Siemens Medical Solutions USA, Inc. | 2008 | — |
| +1 | K190524 | MRopen 0.5 T | Asg Superconductors S.P.A. | 2019 | — |
| +2 | K193116 | MRopen EVO | Asg Superconductors S.P.A. | 2019 | — |
| +3 | K242258 | MROpen Evo (03-2000-00); MROpen Evo (03-4000-00) | Asg Superconductors S.P.A. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 2 | 0 |
| 2024 | 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.
Planning a device in LNH? 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 |
|---|---|---|---|
| * | K071925 | Magnetom EssenzaSummary page 3…will assure that the performance of this device can be considered safe and effective with respect to the currently available MAGNETOM C!( K043030) and MAGNETOM ESSENZA (K071925). DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service… | 2007 |
| * | K043030 | Magnetom C! MR SystemSummary page 2…TOM C! system is an open, whole body scanner designed to support improved higher resolution imaging and shorter scan times, which was described in premarket notification K043030 which received FDA clearance on December, 10, 2004. Siemens intends to modify the RF Infra Structure, RF Signal Unit, Filter Plat… | 2004 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K190524 | MRopen 0.5 T | 2019 | 2 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 2 companies; a new generation was cleared every 1.1 years on median.
- 8 of the 14 ancestors have a recall of any class.
- Of its descendants, K190524 (Asg Superconductors S.P.A., 2019) has gone furthest, with 2 descendants of its own.
- 4 other devices also cite its predicate K071925.
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. 2008, 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?
The MAGNETOM C! is indicated for use as magnetic resonance diagnostic devices (MRDD) that produce transverse, sagittal, coronal and oblique cross sectional images, and that display the internal structure and/or function of the head, body, or extremities. Depending on the region of interest, contrast agents may be used. These images when interpreted by a trained physician yield information that may assist in diagnosis. The MAGNETOM C! may also be used for…
Read the full statement (113 words)
The MAGNETOM C! is indicated for use as magnetic resonance diagnostic devices (MRDD) that produce transverse, sagittal, coronal and oblique cross sectional images, and that display the internal structure and/or function of the head, body, or extremities. Depending on the region of interest, contrast agents may be used. These images when interpreted by a trained physician yield information that may assist in diagnosis.
The MAGNETOM C! may also be used for imaging during interventional procedures when performed with MR compatible devices such as, in room display and MR safe biopsy needles
Disclaimer: Utility of contrast enhanced breast MRI for the detection of breast masses has not been documented and is thus not indicated.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082331 · printed Nov 5, 2026
Cite this page
510(k) Report. “K082331: Magnetom C!.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K082331
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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