510(k) · Cleared

Cleared

3.0T GEM RT Open Array

K143389510(k) TraditionalCleared Mar 6, 2015100-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

Ge Healthcare Coils (Usa Instruments, Inc.) · MOS Coil, Magnetic Resonance, Specialty

Cleared on Mar 6, 2015 as substantially equivalent to K123327 (Ge Healthcare Coils (Usa Instruments, Inc.), 2013) after a 100-day review. Its family tree reaches back 11 generations to 1997. 5 of the 28 devices in its family, counting itself, have a Class I recall. 1 later device descends from it.

Decided: Mar 6, 2015
Review: 100 days
Class: Class II
Product code: MOS
Recalls: None
Predicates: 1

Its longest line of descent runs back 11 generations to K971684 (1997). 26 ancestors in all, the oldest K962061 (1996). 1 later device descends from it, 1 citing it directly. 5 of the 28 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 11 generations backK971684 Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
7 generations between
3 generations backK091536 Optima MR450WGe Medical Systems, LLC · 2009 · Recalled
2 generations backK103335 Gem Option for 1.5 Mri SystemsGE Healthcare · 2011 · Recalled
1 generation backK123327 1.5T Gem RT Open ArrayGe Healthcare Coils (Usa Instruments, Inc.) · 2013
This deviceK143389 3.0T GEM RT Open ArrayGe Healthcare Coils (Usa Instruments, Inc.) · 2015
Descendant · cites it directly · 0 of its ownK213687 32Ch AIR Open Coil Suite: 1.5T AIR Open Head Neck Posterior 9ch /…Neocoil, LLC · 2022

Show all 11 generations

Root · 11 generations backK971684 Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
10 generations backK032428 Magnetom Avanto MR SystemSiemens Medical Solutions USA, Inc. · 2003 · Recalled
9 generations backK041112 Magnetom Espree SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
8 generations backK052164 Magnetom Systems with Software Syngo MR 2006ASiemens Medical Solutions USA, Inc. · 2005
7 generations backK062454 Magnetom Systems - I-Class and T-Class ReleasesSiemens Medi Cal Solutions, Inc. · 2006
6 generations backK072237 Magnetom VerioSiemens Medical Solutions USA, Inc. · 2007 · Recalled (Class I)
5 generations backK081028 Signa 3.0T MR750 SystemGe Medical Systems, LLC · 2008 · Recalled
4 generations backK083147 Discovery MR450Ge Medical Systems, LLC · 2008 · Recalled
3 generations backK091536 Optima MR450WGe Medical Systems, LLC · 2009 · Recalled
2 generations backK103335 Gem Option for 1.5 Mri SystemsGE Healthcare · 2011 · Recalled
1 generation backK123327 1.5T Gem RT Open ArrayGe Healthcare Coils (Usa Instruments, Inc.) · 2013
This deviceK143389 3.0T GEM RT Open ArrayGe Healthcare Coils (Usa Instruments, Inc.) · 2015

Class I recalls in this family

K072237 Magnetom Verio6 generations back · 2007
K041476 GE Signa Excite 1.5T MR System, GE Signa Excite…6 generations back · 2004
K030874 GE 3.0T Signa Infinity Twinspeed with Excite MR…7 generations back · 2003
K013636 Signa Infinity MR System with Excite Technology7 generations back · 2002

Most influential descendants

Showing 1 of 1 · See all

K21368732Ch AIR Open Coil Suite: 1.5T AIR Open Head Neck Posterior 9ch / 3.0T AIR Open Head…Neocoil, LLC · 2022 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−11	K971684	Magnetom Project 047 System (Numaris 3.5 Software)	Siemens Medical Solutions USA, Inc.	1997	4
−10	K032428	Magnetom Avanto MR System	Siemens Medical Solutions USA, Inc.	2003	4
−9	K041112	Magnetom Espree System	Siemens Medical Solutions USA, Inc.	2004	4
−8	K052164	Magnetom Systems with Software Syngo MR 2006A	Siemens Medical Solutions USA, Inc.	2005	—
−7	K062454	Magnetom Systems - I-Class and T-Class Releases	Siemens Medi Cal Solutions, Inc.	2006	—
−6	K072237	Magnetom Verio	Siemens Medical Solutions USA, Inc.	2007	Class I
−5	K081028	Signa 3.0T MR750 System	Ge Medical Systems, LLC	2008	11
−4	K083147	Discovery MR450	Ge Medical Systems, LLC	2008	10
−3	K091536	Optima MR450W	Ge Medical Systems, LLC	2009	8
−2	K103335	Gem Option for 1.5 Mri Systems	GE Healthcare	2011	3
−1	K123327	1.5T Gem RT Open Array	Ge Healthcare Coils (Usa Instruments, Inc.)	2013	—
0 (this device)	K143389	3.0T GEM RT Open Array	Ge Healthcare Coils (Usa Instruments, Inc.)	2015	—
+1	K213687	32Ch AIR Open Coil Suite: 1.5T AIR Open Head Neck Posterior 9ch / 3.0T AIR…	Neocoil, LLC	2022	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0
1998	1	0
1999	2	0
2001	4	1
2002	2	1
2003	1	1
2004	1	1
2005	3	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2022	1	0

FIG. 1 — Lineage of K143389, 1997–2022Source: 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.

5 devices in this family have a Class I recall. 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

Get a 510(k) Report

What was it cleared against? (1)

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
*	K123327	1.5T Gem RT Open Array Summary page 4 …agnetic Resonance, Specialty Classification Names: 21CFR 892.1000 – Magnetic resonance diagnostic device Product Code: MOS Predicate Device(s): K123327, 1.5T GEM RT Open Array Device Description: The 3.0T GEM RT Open Array is a receive-only coil…	Ge Healthcare Coils (Usa Instruments, Inc.)	2013	—

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K213687	32Ch AIR Open Coil Suite: 1.5T AIR Open Head Neck Posterior 9ch / 3.0T AIR Open Head…	Neocoil, LLC	2022	0

Has anything in its family been recalled? (5 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K072237Magnetom VerioSiemens Medical Solutions USA, Inc. · 2007 · 6 generations back · ◆ on the line of descent in FIG. 11 Class I recall
K041476GE Signa Excite 1.5T MR System, GE Signa Excite 3.0T MR SystemGe Medical Systems, LLC · 2004 · 6 generations back · ◆ in the 2004 ancestors bar of FIG. 11 Class I recall
K030874GE 3.0T Signa Infinity Twinspeed with Excite MR SystemGeneral Electric Co. · 2003 · 7 generations back · ◆ in the 2003 ancestors bar of FIG. 11 Class I recall
K013636Signa Infinity MR System with Excite TechnologyGE Medical Systems · 2002 · 7 generations back · ◆ in the 2002 ancestors bar of FIG. 11 Class I recall
K0122001.5T Infinity Twinspeed MR SystemGE Medical Systems · 2001 · 8 generations back · ◆ in the 2001 ancestors bar of FIG. 11 Class I recall

What does this lineage say?

The line of descent spans 18 years and passes through 5 companies; a new generation was cleared every 1.1 years on median.
18 of the 26 ancestors have a recall of any class; 5 have a Class I recall.
Of its descendants, K213687 (Neocoil, LLC, 2022) has gone furthest, with 0 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. 2015, this device’s year, is highlighted.

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 3.0T GEM RT Open Array Coil, part of the Oncology Suite, is a receive-only RF coil designed for use with 3.0T MRI systems manufactured by GE. The indications for use include the head, neck, and brachial plexus anatomies and vasculature imaging. The nucleus excited is hydrogen.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K143389 · printed Nov 4, 2026

Cite this page

510(k) Report. “K143389: 3.0T GEM RT Open Array.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K143389

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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