510(k) · Cleared

Cleared

Mrgfus General Purpose and Breast Coil

K061715510(k) TraditionalCleared Jul 28, 200639-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

Insightec Txsonics, Inc. · MOS Coil, Magnetic Resonance, Specialty

Cleared on Jul 28, 2006 as substantially equivalent to K030953 (Ge Medical Systems, Inc., 2003) and 3 other predicates after a 39-day review. Its family tree reaches back 5 generations to 1989. 2 later devices descend from it.

Decided: Jul 28, 2006
Review: 39 days
Class: Class II
Product code: MOS
Recalls: None
Predicates: 5

Its longest line of descent runs back 5 generations to K893619 (1989). 22 ancestors in all. 2 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 5 generations backK893619 Vista MR 2055 HP SystemPhilips Medical Systems (Cleveland), Inc. · 1989
4 generations backK960497 Flexible Phased Array Spine CoilPhilips Medical Systems (Cleveland), Inc. · 1996
3 generations backK983143 Mark 5000 Phased Array Shoulder CoilUsa Instruments, Inc. · 1998
2 generations backK013854 Mark 5000 Quadrature Shoulder CoilUsa Instruments, Inc. · 2002
1 generation backK033753 Pelvic Array CoilUsa Instruments, Inc. · 2003
This deviceK061715 Mrgfus General Purpose and Breast CoilInsightec Txsonics, Inc. · 2006
Descendant · cites it directly · 1 of its ownK083434 TT1 General Purpose CoilTursiop Technologies, LLC · 2008
Descendant · 2 generations on · 0 of its ownK113280 Carotid Coil GE 1.5TTursiop Technologies, LLC · 2011

Most influential descendants

Showing 2 of 2 · See all

K083434TT1 General Purpose CoilTursiop Technologies, LLC · 2008 · cites it directly1descendant
K113280Carotid Coil GE 1.5TTursiop Technologies, LLC · 2011 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−5	K893619	Vista MR 2055 HP System	Philips Medical Systems (Cleveland), Inc.	1989	—
−4	K960497	Flexible Phased Array Spine Coil	Philips Medical Systems (Cleveland), Inc.	1996	—
−3	K983143	Mark 5000 Phased Array Shoulder Coil	Usa Instruments, Inc.	1998	—
−2	K013854	Mark 5000 Quadrature Shoulder Coil	Usa Instruments, Inc.	2002	—
−1	K033753	Pelvic Array Coil	Usa Instruments, Inc.	2003	—
0 (this device)	K061715	Mrgfus General Purpose and Breast Coil	Insightec Txsonics, Inc.	2006	—
+1	K083434	TT1 General Purpose Coil	Tursiop Technologies, LLC	2008	—
+2	K113280	Carotid Coil GE 1.5T	Tursiop Technologies, LLC	2011	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1991	1	0
1992	1	0
1993	1	0
1995	2	0
1997	1	0
1998	4	0
1999	1	0
2000	2	0
2003	1	0
2004	1	0
2005	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	1	0
2011	1	0

FIG. 1 — Lineage of K061715, 1989–2011Source: 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 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
#3 Held for the reportin the report

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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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

Type	Number	Device	Applicant	Decided	Recalls
Kept off the family tree	K982001	Medrad Breast Coil Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
*	K030953	GE 3.0T General Purpose Flex Coil Summary page 2 …Panel: Radiology 5.11 Predicate Devices: * The Medrad Breast Coil (Medrad, Inc.), K982 1 * The GE 3.OT General Purpose Flex Coil (GE Medical Systems), K030953 * Pelvic Array Coil (USA Instruments, Inc.), K033753. * The 3.OT HD Breast Array (USA Instruments, Inc.), K052585 • The…	Ge Medical Systems, Inc.	2003	—
*	K033753	Pelvic Array Coil Summary page 2 …ad Breast Coil (Medrad, Inc.), K982 1 * The GE 3.OT General Purpose Flex Coil (GE Medical Systems), K030953 * Pelvic Array Coil (USA Instruments, Inc.), K033753. * The 3.OT HD Breast Array (USA Instruments, Inc.), K052585 • The GE 5 inch General Purpose Coil (GE Medical Systems), P83…	Usa Instruments, Inc.	2003	—
*	K052585	3T HD Breast Array Summary page 2 …ral Purpose Flex Coil (GE Medical Systems), K030953 * Pelvic Array Coil (USA Instruments, Inc.), K033753. * The 3.OT HD Breast Array (USA Instruments, Inc.), K052585 • The GE 5 inch General Purpose Coil (GE Medical Systems), P830074, supplement number 6, LNH; Magnetic resonance diagnos…	Usa Instruments, Inc.	2005	5
*	P830074	GE Signa Magnetic Resonance Diagnostic Imaging Sys FDA lists this PMA only through its supplements; the earliest we hold is P830074/S001 (Sep 10, 1985). Summary page 2 …Array Coil (USA Instruments, Inc.), K033753. * The 3.OT HD Breast Array (USA Instruments, Inc.), K052585 • The GE 5 inch General Purpose Coil (GE Medical Systems), P830074, supplement number 6, LNH; Magnetic resonance diagnostic devices were reclassified by FDA from Class III to Class II,…	General Electric Co.		—

Also cleared against K030953: 1 other device →

What descends from it? (2)

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

Number	Device	Applicant	Decided	Descendants
K083434	TT1 General Purpose Coil	Tursiop Technologies, LLC	2008	1

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 17 years and passes through 3 companies; a new generation was cleared every 2.6 years on median.
3 of the 21 ancestors have a recall of any class.
Of its descendants, K083434 (Tursiop Technologies, LLC, 2008) has gone furthest, with 1 descendant of its own.
1 other device also cites its predicate K030953.

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	—

What is it indicated for?

The MRgFUS General Purpose and Breast Coil (the MRgFUS Coil) is a receive only RF coil, designed for MR imaging of the breast and auxiliary tissue and of a variety of medium-sized anatomical regions, such as spine, neck, shoulder, thigh, foot ankle and joints.

The MRgFUS Coil is designed for use with the GE Signa TM (1.5T or 3.0T) MRI systems manufactured by GE Medical Systems.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K061715 · printed Nov 6, 2026

Cite this page

510(k) Report. “K061715: Mrgfus General Purpose and Breast Coil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061715

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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