510(k) · Cleared

Cleared

Mark 9000 Phased Array Shoulder Coil

K010946510(k) TraditionalCleared May 30, 200162-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

Usa Instruments, Inc. · MOS Coil, Magnetic Resonance, Specialty

Cleared on May 30, 2001 after a 62-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.

Decided: May 30, 2001
Review: 62 days
Class: Class II
Product code: MOS
Recalls: None
Predicates: 0

4 later devices descend from it, 2 citing it directly.

This deviceK010946 Mark 9000 Phased Array Shoulder CoilUsa Instruments, Inc. · 2001
Descendant · cites it directly · 2 of its ownK042009 Mark Iii Phased Array Shoulder CoilUsa Instruments, Inc. · 2004
Descendant · 2 generations on · 1 of its ownK071611 Neocoil 3.0T 8-Channel Shoulder Array CoilNeocoil · 2007
Descendant · 3 generations on · 0 of its ownK201101 1.5T 16ch Shoulder Coil, 3.0T 16ch Shoulder CoilNeocoil, LLC · 2020
Descendant · cites it directly · 0 of its ownK020268 Isaac 1.5 T MR SystemChi, Inc. · 2002

Most influential descendants

Showing 4 of 4 · See all

K042009Mark Iii Phased Array Shoulder CoilUsa Instruments, Inc. · 2004 · cites it directly2descendants
K071611Neocoil 3.0T 8-Channel Shoulder Array CoilNeocoil · 2007 · 2 generations on1descendant
K2011011.5T 16ch Shoulder Coil, 3.0T 16ch Shoulder CoilNeocoil, LLC · 2020 · 3 generations on0descendants
K020268Isaac 1.5 T MR SystemChi, Inc. · 2002 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K010946	Mark 9000 Phased Array Shoulder Coil	Usa Instruments, Inc.	2001	—
+1	K042009	Mark Iii Phased Array Shoulder Coil	Usa Instruments, Inc.	2004	—
+2	K071611	Neocoil 3.0T 8-Channel Shoulder Array Coil	Neocoil	2007	—
+3	K201101	1.5T 16ch Shoulder Coil, 3.0T 16ch Shoulder Coil	Neocoil, LLC	2020	—
+1	K020268	Isaac 1.5 T MR System	Chi, Inc.	2002	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2004	1	0
2007	1	0
2020	1	0

FIG. 1 — Lineage of K010946, 2001–2020Source: 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 MOS? 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 MOS device

#1 K253738 3.0T Air 32CH Hnascore 15.2 · 16 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? (4)

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

Number	Device	Applicant	Decided	Descendants
K042009	Mark Iii Phased Array Shoulder Coil	Usa Instruments, Inc.	2004	2
K020268	Isaac 1.5 T MR System	Chi, Inc.	2002	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, K042009 (Usa Instruments, Inc., 2004) has gone furthest, with 2 descendants of its own.

How does its category compare?

All MOS devices

MOS Coil, Magnetic Resonance, Specialty: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MOS

3in 2025

2007high 25 (2011) · low 3 (2019)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MOS

59in 2025

2007high 178 (2019) · low 19 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MOS

13in 2024

2007high 13 (2024) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MOS

2in 2025

2007high 13 (2010) · low 2 (2008)2025

MAUDE reports naming product code MOS, 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	16	19	0	4
2008	19	33	2	2
2009	10	43	0	5
2010	16	78	1	13
2011	25	57	0	7
2012	15	49	1	12
2013	7	87	0	10
2014	12	60	0	4
2015	6	58	2	5
2016	11	42	0	7
2017	9	63	0	9
2018	10	30	0	7
2019	3	178	8	8
2020	5	51	1	2
2021	4	41	0	3
2022	11	79	0	5
2023	10	59	0	4
2024	10	39	13	8
2025	3	59	0	2
2026	10	45	0	—

https://510kreport.com/device/K010946 · printed Nov 6, 2026

Cite this page

510(k) Report. “K010946: Mark 9000 Phased Array Shoulder Coil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010946

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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