510(k) · Cleared

Cleared

Dynamic Mri Software Option for C-Scan, E-Scan XQ and E-Scan Opera

K061429510(k) TraditionalCleared Jul 25, 200663-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

Esaote, S.p.A. · LNH System, Nuclear Magnetic Resonance Imaging

Cleared on Jul 25, 2006 as substantially equivalent to K040877 (Esaote, S.p.A., 2004) and 4 other predicates after a 63-day review. Its family tree reaches back 8 generations to 1991. 32 later devices descend from it.

Decided: Jul 25, 2006
Review: 63 days
Class: Class II
Product code: LNH
Recalls: None
Predicates: 5

Its longest line of descent runs back 8 generations to K911667 (1991). 36 ancestors in all. 32 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 8 generations backK911667 Hitachi MRP-7000 Magnetic Rosonance DeviceHitachi Medical Systems America, Inc. · 1991 · Recalled
7 generations backK963262 Artoscan MBiosound, Inc. · 1997
6 generations backK981358 Artoscan SBiosound Esaote, Inc. · 1998
5 generations backK990968 E-SCANBiosound Esaote, Inc. · 1999
4 generations backK020164 E-Scan XQBiosound Esaote, Inc. · 2002
3 generations backK032121 Modification to E-Scan XQEsaote, S.p.A. · 2003
2 generations backK042236 G-SCANEsaote, S.p.A. · 2004
1 generation backK060956 G-Scan-Model 9800020000, E-Scan Model 9800010000 and E-Scan…Esaote, S.p.A. · 2006
This deviceK061429 Dynamic Mri Software Option for C-Scan, E-Scan XQ and E-Scan OperaEsaote, 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
Descendant · 4 generations on · 11 of its ownK122006 G-Scan BrioEsaote, S.p.A. · 2012

Showing 5 of 32 descendants. See all descendants

Descendants cleared per year

2008high 5 (2012) · low 0 (2014)2026

Most influential descendants

Showing 5 of 32 · See all

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
K122006G-Scan BrioEsaote, S.p.A. · 2012 · 4 generations on11descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−8	K911667	Hitachi MRP-7000 Magnetic Rosonance Device	Hitachi Medical Systems America, Inc.	1991	2
−7	K963262	Artoscan M	Biosound, Inc.	1997	—
−6	K981358	Artoscan S	Biosound Esaote, Inc.	1998	—
−5	K990968	E-SCAN	Biosound Esaote, Inc.	1999	—
−4	K020164	E-Scan XQ	Biosound Esaote, Inc.	2002	—
−3	K032121	Modification to E-Scan XQ	Esaote, S.p.A.	2003	—
−2	K042236	G-SCAN	Esaote, S.p.A.	2004	—
−1	K060956	G-Scan-Model 9800020000, E-Scan Model 9800010000 and E-Scan…	Esaote, S.p.A.	2006	—
0 (this device)	K061429	Dynamic Mri Software Option for C-Scan, E-Scan XQ and E-Scan Opera	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	—
+4	K122006	G-Scan Brio	Esaote, S.p.A.	2012	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1991	4	0
1992	2	0
1993	4	0
1994	4	0
1995	3	0
1996	1	0
1997	1	0
1998	1	0
1999	1	0
2000	3	0
2001	3	0
2004	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	3	0
2009	2	0
2010	1	0
2011	4	0
2012	5	0
2013	3	0
2015	3	0
2016	3	0
2017	1	0
2019	1	0
2021	1	0
2022	1	0
2024	1	0
2026	3	0

FIG. 1 — Lineage of K061429, 1991–2026Source: 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

Get a 510(k) Report

What was it cleared against? (5)

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
*	K040877	Artoscan C Summary page 1 …: 9OLNH 807.92(a)(3) Predicate Device(s) Emote C-scan K040877 Esaote E-scan XQ K032121 Esaote E-scan O…	Esaote, S.p.A.	2004	—
*	K032121	Modification to E-Scan XQ Summary page 1 …te C-scan K040877 Esaote E-scan XQ K032121 Esaote E-scan Opera K060956 Siemens Medical Systems Perfusio…	Esaote, S.p.A.	2003	—
*	K060956	G-Scan-Model 9800020000, E-Scan Model 9800010000 and E-Scan… Summary page 1 …ote E-scan XQ K032121 Esaote E-scan Opera K060956 Siemens Medical Systems Perfusion Package for Magnetom Vision K984224 and Symph…	Esaote, S.p.A.	2006	—
*	K984224	Perfusion Package for Magnetom Vision and Symphony Systems Summary page 1 …ote E-scan Opera K060956 Siemens Medical Systems Perfusion Package for Magnetom Vision K984224 and Symphony MR Systems GE Medical Systems Advantage Windows with FuncTool Option…	Siemens Corp.	1999	—
*	K960265	Advantage Windows with Functool Option Summary page 1 …tom Vision K984224 and Symphony MR Systems GE Medical Systems Advantage Windows with FuncTool Option K960265 44 510(k) Summary C-s…	GE Medical Systems	1996	1

Also cleared against K040877: 1 other device →

What descends from it? (32)

See all 32

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

Number	Device	Applicant	Decided	Descendants
K080968	S-Scan, G-Scan, Dynamic Mri Software for C-Scan, E-Scanxq & E-Scan Opera	Esaote, S.p.A.	2008	24
K073167	Brainstat Software Option for GE Signa MR Scanner	Ge Medical Systems, LLC	2008	6
K080762	IB Neuro, Version 1.0	Imaging Biometrics, LLC	2008	5

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 15 years and passes through 4 companies; a new generation was cleared every 1.5 years on median.
7 of the 36 ancestors have a recall of any class.
Of its descendants, K080968 (Esaote, S.p.A., 2008) has gone furthest, with 24 descendants of its own.
1 other device also cites its predicate K040877.

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 Dynamic MRI Software Option for C-scan, E-scan XQ and E-scan Opera MRI Systems allows the acquisition of MR dynamic image datasets and the post processing display of temporal variations in the acquired datasets, showing changes in contrast over time. Its purpose is to provide time intensity curves that support the diagnostic process. These images 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/K061429 · printed Nov 6, 2026

Cite this page

510(k) Report. “K061429: Dynamic Mri Software Option for C-Scan, E-Scan XQ and E-Scan Opera.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061429

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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