510(k) · Cleared
ClearedMagnetom C! MR System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions · LNH System, Nuclear Magnetic Resonance Imaging
Cleared on Dec 9, 2004 as substantially equivalent to K003192 (Siemens Medical Solutions USA, Inc., 2000) and 2 other predicates after a 36-day review. Its family tree reaches back 2 generations to 1997. 37 later devices descend from it.
- Decided
- Dec 9, 2004
- Review
- 36 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K970852 (1997). 3 ancestors in all. 37 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK970852 Magnetom Project 024 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 1 generation backK041111 Magnetom C! MR SystemSiemens Medical Solutions USA, Inc. · 2004
- This deviceK043030 Magnetom C! MR SystemSiemens Medical Solutions · 2004
- Descendant · cites it directly · 34 of its ownK063207 S-Scan Mri SystemEsaote, S.p.A. · 2006
- Descendant · cites it directly · 24 of its ownK080968 S-Scan, G-Scan, Dynamic Mri Software for C-Scan, E-Scanxq & E-Scan…Esaote, S.p.A. · 2008
- Descendant · 2 generations on · 18 of its ownK092469 O-Scan MR SystemEsaote, S.p.A. · 2009
- Descendant · 2 generations on · 15 of its ownK110238 G-SCANEsaote, S.p.A. · 2011
- Descendant · 3 generations on · 14 of its ownK111803 G-SCANEsaote, S.p.A. · 2011
Showing 5 of 37 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 37 · See all- K063207S-Scan Mri SystemEsaote, S.p.A. · 2006 · cites it directly34descendants
- K080968S-Scan, G-Scan, Dynamic Mri Software for C-Scan, E-Scanxq & E-Scan OperaEsaote, S.p.A. · 2008 · cites it directly24descendants
- K092469O-Scan MR SystemEsaote, S.p.A. · 2009 · 2 generations on18descendants
- K110238G-SCANEsaote, S.p.A. · 2011 · 2 generations on15descendants
- K111803G-SCANEsaote, S.p.A. · 2011 · 3 generations on14descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K970852 | Magnetom Project 024 System (Numaris 3.5 Software) | Siemens Medical Solutions USA, Inc. | 1997 | 8 |
| −1 | K041111 | Magnetom C! MR System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| 0 (this device) | K043030 | Magnetom C! MR System | Siemens Medical Solutions | 2004 | — |
| +1 | K063207 | S-Scan Mri System | Esaote, S.p.A. | 2006 | — |
| +1 | K080968 | S-Scan, G-Scan, Dynamic Mri Software for C-Scan, E-Scanxq & E-Scan Opera | Esaote, S.p.A. | 2008 | — |
| +2 | K092469 | O-Scan MR System | Esaote, S.p.A. | 2009 | — |
| +2 | K110238 | G-SCAN | Esaote, S.p.A. | 2011 | — |
| +3 | K111803 | G-SCAN | Esaote, S.p.A. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 4 | 0 |
| 2012 | 6 | 0 |
| 2013 | 2 | 0 |
| 2015 | 4 | 0 |
| 2016 | 3 | 0 |
| 2019 | 4 | 0 |
| 2022 | 1 | 0 |
| 2024 | 2 | 0 |
| 2026 | 3 | 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? (3)
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 |
|---|---|---|---|
| * | K003192 | Magnetic ConcertoSummary page 2…PredicateDevice NameNubrDt Number Date Siemens MAGNETOM 0.2 T Concerto K003192 12/21/2000 Siemens MAGNETOM 1.0 T Harmony K970852 06/05/1997 Siemens… | 2000 |
| * | K970852 | Magnetom Project 024 System (Numaris 3.5 Software)Summary page 2…Number Date Siemens MAGNETOM 0.2 T Concerto K003192 12/21/2000 Siemens MAGNETOM 1.0 T Harmony K970852 06/05/1997 Siemens MAGNETOM 0.35 T C! K041111 07/16/2004 Siemens 510(k)… | 1997 |
| * | K041111 | Magnetom C! MR SystemSummary page 2…C! system is an open, whole body scanner designed to support improved higher resolution imaging and shorter scan times, which is was described in premarket notification K041 111 which received FDA clearance on July 16, 2004. Siemens further market the Body spine XL coil, Wrist Array coil with 4 channels, C… | 2004 |
What descends from it? (37)
See all 374 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 7 years and passes through 2 companies; a new generation was cleared every 7.1 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K063207 (Esaote, S.p.A., 2006) has gone furthest, with 34 descendants of its own.
- 5 other devices also cite its predicate K003192.
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.
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, spectroscopic images and/or spectra, and that display the internal structure and/or function of the head, body, or extremities. These images and/or spectra 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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043030 · printed Nov 4, 2026
Cite this page
510(k) Report. “K043030: Magnetom C! MR System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K043030
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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