510(k) · Cleared

Cleared

Magnetom Vision (Project 016)

K945517510(k) TraditionalCleared Oct 7, 1995332-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 Oct 7, 1995 after a 332-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 44 later devices descend from it.

Decided: Oct 7, 1995
Review: 332 days
Class: Class II
Product code: LNH
Recalls: None
Predicates: 0

44 later devices descend from it, 1 citing it directly.

This deviceK945517 Magnetom Vision (Project 016)Siemens Medical Solutions USA, Inc. · 1995
Descendant · cites it directly · 43 of its ownK060956 G-Scan-Model 9800020000, E-Scan Model 9800010000 and E-Scan…Esaote, S.p.A. · 2006
Descendant · 2 generations on · 34 of its ownK063207 S-Scan Mri SystemEsaote, S.p.A. · 2006
Descendant · 2 generations on · 32 of its ownK061429 Dynamic Mri Software Option for C-Scan, E-Scan XQ and E-Scan OperaEsaote, S.p.A. · 2006
Descendant · 3 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 · 4 generations on · 18 of its ownK092469 O-Scan MR SystemEsaote, S.p.A. · 2009

Showing 5 of 44 descendants. See all descendants

Descendants cleared per year

2006high 7 (2012) · low 0 (2007)2026

Most influential descendants

Showing 5 of 44 · See all

K060956G-Scan-Model 9800020000, E-Scan Model 9800010000 and E-Scan…Esaote, S.p.A. · 2006 · cites it directly43descendants
K063207S-Scan Mri SystemEsaote, S.p.A. · 2006 · 2 generations on34descendants
K061429Dynamic Mri Software Option for C-Scan, E-Scan XQ and E-Scan OperaEsaote, S.p.A. · 2006 · 2 generations on32descendants
K080968S-Scan, G-Scan, Dynamic Mri Software for C-Scan, E-Scanxq & E-Scan OperaEsaote, S.p.A. · 2008 · 3 generations on24descendants
K092469O-Scan MR SystemEsaote, S.p.A. · 2009 · 4 generations on18descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K945517	Magnetom Vision (Project 016)	Siemens Medical Solutions USA, Inc.	1995	—
+1	K060956	G-Scan-Model 9800020000, E-Scan Model 9800010000 and E-Scan…	Esaote, S.p.A.	2006	—
+2	K063207	S-Scan Mri System	Esaote, S.p.A.	2006	—
+2	K061429	Dynamic Mri Software Option for C-Scan, E-Scan XQ and E-Scan Opera	Esaote, S.p.A.	2006	—
+3	K080968	S-Scan, G-Scan, Dynamic Mri Software for C-Scan, E-Scanxq & E-Scan Opera	Esaote, S.p.A.	2008	—
+4	K092469	O-Scan MR System	Esaote, S.p.A.	2009	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	3	0
2008	4	0
2009	2	0
2010	2	0
2011	4	0
2012	7	0
2013	3	0
2015	4	0
2016	3	0
2017	1	0
2019	4	0
2021	1	0
2022	1	0
2024	2	0
2026	3	0

FIG. 1 — Lineage of K945517, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (44)

See all 44

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

Number	Device	Applicant	Decided	Descendants
K060956	G-Scan-Model 9800020000, E-Scan Model 9800010000 and E-Scan…	Esaote, S.p.A.	2006	43

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?

Of its descendants, K060956 (Esaote, S.p.A., 2006) has gone furthest, with 43 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	—

https://510kreport.com/device/K945517 · printed Nov 6, 2026

Cite this page

510(k) Report. “K945517: Magnetom Vision (Project 016).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K945517

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026