510(k) · Cleared

Cleared

Cardiac Tagging Techniques/Magnetom Vision and Magnetom Impact

K973799510(k) TraditionalCleared Jan 2, 199888-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 Jan 2, 1998 as substantially equivalent to K900889 (Siemens Medical Solutions USA, Inc., 1990) after an 88-day review. Its family tree reaches back 1 generation to 1990. 95 later devices descend from it.

Decided: Jan 2, 1998
Review: 88 days
Class: Class II
Product code: LNH
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K900889 (1990). 95 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK900889 Magnetic Resonance Diagnostic Device AccessoriesSiemens Medical Solutions USA, Inc. · 1990
This deviceK973799 Cardiac Tagging Techniques/Magnetom Vision and Magnetom ImpactSiemens Medical Solutions USA, Inc. · 1998
Descendant · cites it directly · 90 of its ownK061368 Diagnosoft HarpDiagnosoft, Inc. · 2006
Descendant · 2 generations on · 89 of its ownK100352 Diagnosoft Harp Model 2.06Diagnosoft, Inc. · 2010
Descendant · 3 generations on · 82 of its ownK120135 2D Cardiac Performance Analysis MR 1.0Tomtec Imaging Systems GmbH · 2012
Descendant · 4 generations on · 78 of its ownK132544 Tomtec-Arena 1.0, Tomtec-Arena 3D Echo, Cardio-ArenaTomtec Imaging Systems GmbH · 2013
Descendant · 5 generations on · 56 of its ownK150122 Tomtec-Arena TTA2Tomtec Imaging Systems GmbH · 2015 · Recalled

Showing 5 of 95 descendants. See all descendants

Descendants cleared per year

1998high 17 (2025) · low 0 (2001)2026

Most influential descendants

Showing 5 of 95 · See all

K061368Diagnosoft HarpDiagnosoft, Inc. · 2006 · cites it directly90descendants
K100352Diagnosoft Harp Model 2.06Diagnosoft, Inc. · 2010 · 2 generations on89descendants
K1201352D Cardiac Performance Analysis MR 1.0Tomtec Imaging Systems GmbH · 2012 · 3 generations on82descendants
K132544Tomtec-Arena 1.0, Tomtec-Arena 3D Echo, Cardio-ArenaTomtec Imaging Systems GmbH · 2013 · 4 generations on78descendants
K150122Tomtec-Arena TTA2Tomtec Imaging Systems GmbH · 2015 · 5 generations on56descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K900889	Magnetic Resonance Diagnostic Device Accessories	Siemens Medical Solutions USA, Inc.	1990	—
0 (this device)	K973799	Cardiac Tagging Techniques/Magnetom Vision and Magnetom Impact	Siemens Medical Solutions USA, Inc.	1998	—
+1	K061368	Diagnosoft Harp	Diagnosoft, Inc.	2006	—
+2	K100352	Diagnosoft Harp Model 2.06	Diagnosoft, Inc.	2010	—
+3	K120135	2D Cardiac Performance Analysis MR 1.0	Tomtec Imaging Systems GmbH	2012	—
+4	K132544	Tomtec-Arena 1.0, Tomtec-Arena 3D Echo, Cardio-Arena	Tomtec Imaging Systems GmbH	2013	—
+5	K150122	Tomtec-Arena TTA2	Tomtec Imaging Systems GmbH	2015	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0
1999	1	0
2000	1	0
2002	1	0
2006	1	0
2010	1	0
2011	1	0
2012	1	0
2013	2	0
2015	1	0
2017	5	0
2018	4	0
2019	4	0
2020	13	0
2021	5	0
2022	10	0
2023	10	0
2024	10	0
2025	17	0
2026	6	0

FIG. 1 — Lineage of K973799, 1990–2026Source: 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? (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	Applicant	Decided	Recalls
*	K900889	Magnetic Resonance Diagnostic Device Accessories Summary page 2 …of 1990, MR Cardiac Tagging Techniques are substantially equivalent to Siemens Magnetom Cardiac Cine Techhiques which were originally described in premarket notification K900889 which/vceived FDA clearance on 03/23/90. Signature 0 /5/97 Date MAGNETOM Vision, Impact 510(k) October 3, 1997 510(k) Summary…	Siemens Medical Solutions USA, Inc.	1990	—

What descends from it? (95)

See all 95

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

Number	Device	Applicant	Decided	Descendants
K061368	Diagnosoft Harp	Diagnosoft, Inc.	2006	90
K983110	Flexart,Flexart/Hyper, Visart, Visart/Hyper	Toshiba America Mri, Inc.	1999	2
K982834	Restgrid Package/Gyroscan NT	Philips Medical Systems North America, Inc.	1998	0

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?

Its one ancestor has no recall.
Of its descendants, K061368 (Diagnosoft, Inc., 2006) has gone furthest, with 90 descendants of its own.

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?

Siemens developed Cardiac Tagging pulse sequences for the Magnetom Vision and Impact Systems to allow for the non-invasive evaluation of cardiac wall motion and blood flow. Absence of tag deformation throughout the cardiac cycle is an indicator of dysfunctional myocardium which accompanies a variety of disease states. In addition, Cardiac Tagging may assist in differentiating between fixed thrombus and slowly flowing blood.

Cardiac Tagging is intended as an add-on to routine MR imaging examinations of the heart and great vessels. Tagging may provide additional diagnostic information, which in the hands of a qualified physician, can be useful in the diagnosis of disease.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K973799 · printed Nov 4, 2026

Cite this page

510(k) Report. “K973799: Cardiac Tagging Techniques/Magnetom Vision and Magnetom Impact.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973799

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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