510(k) · Cleared

Cleared

Magnetom C! MR System

K041111510(k) TraditionalCleared Jul 16, 200479-day reviewClass II21 CFR 892.1000

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Siemens Medical Solutions USA, Inc. · LNH System, Nuclear Magnetic Resonance Imaging

Cleared on Jul 16, 2004 as substantially equivalent to K003192 (Siemens Medical Solutions USA, Inc., 2000) and 1 other predicate after a 79-day review. Its family tree reaches back 1 generation to 1997. 38 later devices descend from it.

Decided: Jul 16, 2004
Review: 79 days
Class: Class II
Product code: LNH
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K970852 (1997). 2 ancestors in all. 38 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK970852 Magnetom Project 024 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
This deviceK041111 Magnetom C! MR SystemSiemens Medical Solutions USA, Inc. · 2004
Descendant · cites it directly · 37 of its ownK043030 Magnetom C! MR SystemSiemens Medical Solutions · 2004
Descendant · 2 generations on · 34 of its ownK063207 S-Scan Mri SystemEsaote, S.p.A. · 2006
Descendant · 2 generations on · 24 of its ownK080968 S-Scan, G-Scan, Dynamic Mri Software for C-Scan, E-Scanxq & E-Scan…Esaote, S.p.A. · 2008
Descendant · 3 generations on · 18 of its ownK092469 O-Scan MR SystemEsaote, S.p.A. · 2009
Descendant · 3 generations on · 15 of its ownK110238 G-SCANEsaote, S.p.A. · 2011

Showing 5 of 38 descendants. See all descendants

Descendants cleared per year

2004high 6 (2012) · low 0 (2007)2026

Most influential descendants

Showing 5 of 38 · See all

K043030Magnetom C! MR SystemSiemens Medical Solutions · 2004 · cites it directly37descendants
K063207S-Scan Mri SystemEsaote, S.p.A. · 2006 · 2 generations on34descendants
K080968S-Scan, G-Scan, Dynamic Mri Software for C-Scan, E-Scanxq & E-Scan OperaEsaote, S.p.A. · 2008 · 2 generations on24descendants
K092469O-Scan MR SystemEsaote, S.p.A. · 2009 · 3 generations on18descendants
K110238G-SCANEsaote, S.p.A. · 2011 · 3 generations on15descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K970852	Magnetom Project 024 System (Numaris 3.5 Software)	Siemens Medical Solutions USA, Inc.	1997	8
0 (this device)	K041111	Magnetom C! MR System	Siemens Medical Solutions USA, Inc.	2004	—
+1	K043030	Magnetom C! MR System	Siemens Medical Solutions	2004	—
+2	K063207	S-Scan Mri System	Esaote, S.p.A.	2006	—
+2	K080968	S-Scan, G-Scan, Dynamic Mri Software for C-Scan, E-Scanxq & E-Scan Opera	Esaote, S.p.A.	2008	—
+3	K092469	O-Scan MR System	Esaote, S.p.A.	2009	—
+3	K110238	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
2004	1	0
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

FIG. 1 — Lineage of K041111, 1997–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K003192	Magnetic Concerto Summary page 2 …NameNubrDt Date Number Siemens MAGNETOM 0.2 T Concerto K003192 12/21/2000 Siemens MAGNETOM 1.0 T Harmony K970852 06/05/1997 General Safety…	Siemens Medical Solutions USA, Inc.	2000	—
*	K970852	Magnetom Project 024 System (Numaris 3.5 Software) Summary page 2 …Number Siemens MAGNETOM 0.2 T Concerto K003192 12/21/2000 Siemens MAGNETOM 1.0 T Harmony K970852 06/05/1997 General Safety and Effectiveness Concerns: Operation of the MAGNETOM C! System is substantially equiv…	Siemens Medical Solutions USA, Inc.	1997	8

Also cleared against K003192: 5 other devices →

What descends from it? (38)

See all 38

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K043030	Magnetom C! MR System	Siemens Medical Solutions	2004	37

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?

1 of the 2 ancestors has a recall of any class.
Of its descendants, K043030 (Siemens Medical Solutions, 2004) has gone furthest, with 37 descendants of its own.
5 other devices also cite its predicate K003192.

How does its category compare?

All LNH devices

LNH System, Nuclear Magnetic Resonance Imaging: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LNH

26in 2025

2007high 32 (2020) · low 12 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LNH

122in 2025

2007high 140 (2015) · low 35 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LNH

8in 2025

2007high 71 (2018) · low 0 (2017)2026

Class I (8 since 2007) Class II/III not classified

Adverse event reports per year · LNH

1,263in 2025

2007high 1,263 (2025) · low 84 (2021)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/K041111 · printed Nov 6, 2026

Cite this page

510(k) Report. “K041111: Magnetom C! MR System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041111

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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