510(k) · Cleared

Recalled · 2003

Syngo MR 2002B

K020991510(k) TraditionalCleared Jun 13, 200278-day reviewClass II21 CFR 892.1000Recalls 2

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 Jun 13, 2002 as substantially equivalent to K970852 (Siemens Medical Solutions USA, Inc., 1997) and 5 other predicates after a 78-day review. Its family tree reaches back 1 generation to 1997. 6 later devices descend from it. It has been recalled 2 times.

Decided: Jun 13, 2002
Review: 78 days
Class: Class II
Product code: LNH
Recalls: 2
Predicates: 6

Its longest line of descent runs back 1 generation to K970852 (1997). 6 ancestors in all. 6 later devices descend from it, 4 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 deviceK020991 Syngo MR 2002BSiemens Medical Solutions USA, Inc. · 2002
Descendant · cites it directly · 1 of its ownK102748 31P/1H Head Coil 3T; 23NA/1H Head Coil 3T; 13C/1H Head Coil 3TRapid Biomedical GmbH · 2011
Descendant · cites it directly · 1 of its ownK042718 13C/1H Occipital Headcoil for Magnetom AllegraSiemens Medi Cal Solutions, Inc. · 2004
Descendant · 2 generations on · 0 of its ownK213480 31P/1H Head Coil, 23Na/1H Head Coil, 13C/1H Head CoilRapid Biomedical GmbH · 2023
Descendant · cites it directly · 0 of its ownK102348 31P/1H Dual Tuned Surface Coil 3T; 23NA/ 1H Dual Turned Surface Coil…Rapid Biomedical GmbH · 2010
Descendant · 2 generations on · 0 of its ownK080820 Tem 3002G- HN Dual Tune Head CoilMr Instruments, Inc. · 2008

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2004high 1 (2004) · low 0 (2006)2026

Most influential descendants

Showing 5 of 6 · See all

K10274831P/1H Head Coil 3T; 23NA/1H Head Coil 3T; 13C/1H Head Coil 3TRapid Biomedical GmbH · 2011 · cites it directly1descendant
K04271813C/1H Occipital Headcoil for Magnetom AllegraSiemens Medi Cal Solutions, Inc. · 2004 · cites it directly1descendant
K21348031P/1H Head Coil, 23Na/1H Head Coil, 13C/1H Head CoilRapid Biomedical GmbH · 2023 · 2 generations on0descendants
K10234831P/1H Dual Tuned Surface Coil 3T; 23NA/ 1H Dual Turned Surface Coil 3T; 13C /1H Dual…Rapid Biomedical GmbH · 2010 · cites it directly0descendants
K080820Tem 3002G- HN Dual Tune Head CoilMr Instruments, Inc. · 2008 · 2 generations on0descendants

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)	K020991	Syngo MR 2002B	Siemens Medical Solutions USA, Inc.	2002	—
+1	K102748	31P/1H Head Coil 3T; 23NA/1H Head Coil 3T; 13C/1H Head Coil 3T	Rapid Biomedical GmbH	2011	—
+1	K042718	13C/1H Occipital Headcoil for Magnetom Allegra	Siemens Medi Cal Solutions, Inc.	2004	—
+2	K213480	31P/1H Head Coil, 23Na/1H Head Coil, 13C/1H Head Coil	Rapid Biomedical GmbH	2023	—
+1	K102348	31P/1H Dual Tuned Surface Coil 3T; 23NA/ 1H Dual Turned Surface Coil 3T; 13C…	Rapid Biomedical GmbH	2010	—
+2	K080820	Tem 3002G- HN Dual Tune Head Coil	Mr Instruments, Inc.	2008	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0
1999	1	0
2000	2	0
2001	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2005	1	0
2008	1	0
2010	1	0
2011	1	0
2023	1	0

FIG. 1 — Lineage of K020991, 1997–2023Source: 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

Get a 510(k) Report

What was it cleared against? (6)

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
*	K970852	Magnetom Project 024 System (Numaris 3.5 Software) Summary page 2 …tware upgrade will be available for the following MAGNETOM Family systems: The MAGNETOM 1.O Tesla Harmony system was described in premarket notification K970852 which received FDA clearance on June 5, 1997. The MAGNETOM 1.5 Tesla Symphony system was described in premarket notificat…	Siemens Medical Solutions USA, Inc.	1997	8
*	K971684	Magnetom Project 047 System (Numaris 3.5 Software) Summary page 2 …otification K970852 which received FDA clearance on June 5, 1997. The MAGNETOM 1.5 Tesla Symphony system was described in premarket notification K971684 which received FDA clearance on August 4, 1997. The MAGNETOM 1.5 Tesla Sonata system was described in premarket notifica…	Siemens Medical Solutions USA, Inc.	1997	4
*	K993731	Sonata Gradients/Magnetom Symphony System Summary page 2 …tification K971684 which received FDA clearance on August 4, 1997. The MAGNETOM 1.5 Tesla Sonata system was described in premarket notification K993731 that received FDA clearance on December 23,1999. The MAGNETOM 0.2 Tesla Concerto system was described in premarket notifi…	Siemens Medical Solutions USA, Inc.	1999	4
*	K003192	Magnetic Concerto	Siemens Medical Solutions USA, Inc.	2000	—
*	K002179	Magnetom Allegra System	Siemens Medical Solutions USA, Inc.	2000	2
*	K013586	Magnetom Trio System	Siemens Medical Systems, Inc.	2001	4

Also cleared against K970852: 4 other devices →

What descends from it? (6)

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K102748	31P/1H Head Coil 3T; 23NA/1H Head Coil 3T; 13C/1H Head Coil 3T	Rapid Biomedical GmbH	2011	1
K042718	13C/1H Occipital Headcoil for Magnetom Allegra	Siemens Medi Cal Solutions, Inc.	2004	1
K102348	31P/1H Dual Tuned Surface Coil 3T; 23NA/ 1H Dual Turned Surface Coil 3T; 13C /1H Dual…	Rapid Biomedical GmbH	2010	0
K050132	Neuro II-S	Innovative Magnetic Resonance Imaging Systems, Inc.	2005	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Oct 16, 2003	Not classified	Z-0175-03	Other	Equipment SAR monitor does not accept new patient data, incorrect RF levels may be administered to the patient.
Feb 28, 2003	Not classified	Z-1087-03	Other	software problem This error may cause the loss of peripheral image information when there is a difference between the dimensions of the image matrix and the display segment.

No ancestor or descendant has a Class I recall.

What does this lineage say?

5 of the 6 ancestors have a recall of any class.
Of its descendants, K102748 (Rapid Biomedical GmbH, 2011) has gone furthest, with 1 descendant of its own.
4 other devices also cite its predicate K970852.

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 Systems with the syngo MR 2002B are indicated for use as magnetic resonance diagnostic devices (MRDD’s) 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.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K020991 · printed Nov 5, 2026

Cite this page

510(k) Report. “K020991: Syngo MR 2002B.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K020991

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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