510(k) · Cleared

Cleared

Phased Array Shoulder Coil, Quadrature Shoulder Coil

K945778510(k) TraditionalCleared Mar 23, 1995118-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

Medical Advances, Inc. · LNH System, Nuclear Magnetic Resonance Imaging

Cleared on Mar 23, 1995 after a 118-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 15 later devices descend from it.

Decided: Mar 23, 1995
Review: 118 days
Class: Class II
Product code: LNH
Recalls: None
Predicates: 0

15 later devices descend from it, 5 citing it directly.

This deviceK945778 Phased Array Shoulder Coil, Quadrature Shoulder CoilMedical Advances, Inc. · 1995
Descendant · cites it directly · 7 of its ownK983143 Mark 5000 Phased Array Shoulder CoilUsa Instruments, Inc. · 1998
Descendant · 2 generations on · 5 of its ownK013854 Mark 5000 Quadrature Shoulder CoilUsa Instruments, Inc. · 2002
Descendant · 3 generations on · 4 of its ownK033753 Pelvic Array CoilUsa Instruments, Inc. · 2003
Descendant · 4 generations on · 2 of its ownK061715 Mrgfus General Purpose and Breast CoilInsightec Txsonics, Inc. · 2006
Descendant · cites it directly · 2 of its ownK042009 Mark Iii Phased Array Shoulder CoilUsa Instruments, Inc. · 2004

Showing 5 of 15 descendants. See all descendants

Descendants cleared per year

1996high 2 (2007) · low 0 (1997)2026

Most influential descendants

Showing 5 of 15 · See all

K983143Mark 5000 Phased Array Shoulder CoilUsa Instruments, Inc. · 1998 · cites it directly7descendants
K013854Mark 5000 Quadrature Shoulder CoilUsa Instruments, Inc. · 2002 · 2 generations on5descendants
K033753Pelvic Array CoilUsa Instruments, Inc. · 2003 · 3 generations on4descendants
K061715Mrgfus General Purpose and Breast CoilInsightec Txsonics, Inc. · 2006 · 4 generations on2descendants
K042009Mark Iii Phased Array Shoulder CoilUsa Instruments, Inc. · 2004 · cites it directly2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K945778	Phased Array Shoulder Coil, Quadrature Shoulder Coil	Medical Advances, Inc.	1995	—
+1	K983143	Mark 5000 Phased Array Shoulder Coil	Usa Instruments, Inc.	1998	—
+2	K013854	Mark 5000 Quadrature Shoulder Coil	Usa Instruments, Inc.	2002	—
+3	K033753	Pelvic Array Coil	Usa Instruments, Inc.	2003	—
+4	K061715	Mrgfus General Purpose and Breast Coil	Insightec Txsonics, Inc.	2006	—
+1	K042009	Mark Iii Phased Array Shoulder Coil	Usa Instruments, Inc.	2004	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0
1998	1	0
2001	1	0
2002	1	0
2003	1	0
2004	1	0
2006	1	0
2007	2	0
2008	1	0
2009	1	0
2010	1	0
2011	1	0
2014	1	0
2020	1	0

FIG. 1 — Lineage of K945778, 1995–2020Source: 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
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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? (15)

See all 15

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

Number	Device	Applicant	Decided	Descendants
K983143	Mark 5000 Phased Array Shoulder Coil	Usa Instruments, Inc.	1998	7
K042009	Mark Iii Phased Array Shoulder Coil	Usa Instruments, Inc.	2004	2
K963356	Phased Array Shoulder Coil	Philips Medical Systems (Cleveland), Inc.	1996	2
K093667	Shoulder Speeder Coil	Quality Electrodynamics	2010	0
K013541	Shoulder Coil	Usa Instruments, Inc.	2001	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?

Of its descendants, K983143 (Usa Instruments, Inc., 1998) has gone furthest, with 7 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/K945778 · printed Nov 5, 2026

Cite this page

510(k) Report. “K945778: Phased Array Shoulder Coil, Quadrature Shoulder Coil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K945778

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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