510(k) · Cleared

Cleared

48CH Head Coil

K163205510(k) TraditionalCleared Jan 12, 201758-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 Jan 12, 2017 as substantially equivalent to K143345 (Ge Healthcare Japan Corporation, 2015) after a 58-day review. Its family tree reaches back 14 generations to 1997. 5 of the 35 devices in its family, counting itself, have a Class I recall. 3 later devices descend from it.

Decided: Jan 12, 2017
Review: 58 days
Class: Class II
Product code: MOS
Recalls: None
Predicates: 1

Its longest line of descent runs back 14 generations to K971684 (1997). 31 ancestors in all, the oldest K962061 (1996). 3 later devices descend from it, 2 citing it directly. 5 of the 35 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 14 generations backK971684 Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
10 generations between
3 generations backK132376 Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750W 3.0T…Ge Healthcare (Ge Medical Systems, LLC) · 2013 · Recalled
2 generations backK142085 Discovery MR750 3.0T ,Discovery MR450 1.5T, Discovery MR750…Ge Medical Systems, LLC · 2014 · Recalled
1 generation backK143345 SIGNA PioneerGe Healthcare Japan Corporation · 2015 · Recalled
This deviceK163205 48CH Head CoilGe Healthcare Coils (Usa Instruments, Inc.) · 2017
Descendant · cites it directly · 1 of its ownK180666 48CH Head CoilGe Healthcare Coils (Usa Instruments, Inc.) · 2018
Descendant · 2 generations on · 0 of its ownK253738 3.0T Air 32CH HnaGe Healthcare Coils (Usa Instruments, Inc.) · 2026
Descendant · cites it directly · 0 of its ownK183186 Head Coil – 12, Head Coil – 32, Carotid Coil – 8, Temporomandibular…Shanghai United Imaging Healthcare Co., Ltd. · 2019

Show all 14 generations

Root · 14 generations backK971684 Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
13 generations backK032428 Magnetom Avanto MR SystemSiemens Medical Solutions USA, Inc. · 2003 · Recalled
12 generations backK041112 Magnetom Espree SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
11 generations backK052164 Magnetom Systems with Software Syngo MR 2006ASiemens Medical Solutions USA, Inc. · 2005
10 generations backK062454 Magnetom Systems - I-Class and T-Class ReleasesSiemens Medi Cal Solutions, Inc. · 2006
9 generations backK072237 Magnetom VerioSiemens Medical Solutions USA, Inc. · 2007 · Recalled (Class I)
8 generations backK081028 Signa 3.0T MR750 SystemGe Medical Systems, LLC · 2008 · Recalled
7 generations backK083147 Discovery MR450Ge Medical Systems, LLC · 2008 · Recalled
6 generations backK091536 Optima MR450WGe Medical Systems, LLC · 2009 · Recalled
5 generations backK113490 Optima MR450WGe Medical Systems, LLC · 2012 · Recalled
4 generations backK123522 Optima MR450WGe Healthcare (Ge Medical Systems, LLC) · 2013 · Recalled
3 generations backK132376 Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750W 3.0T…Ge Healthcare (Ge Medical Systems, LLC) · 2013 · Recalled
2 generations backK142085 Discovery MR750 3.0T ,Discovery MR450 1.5T, Discovery MR750…Ge Medical Systems, LLC · 2014 · Recalled
1 generation backK143345 SIGNA PioneerGe Healthcare Japan Corporation · 2015 · Recalled
This deviceK163205 48CH Head CoilGe Healthcare Coils (Usa Instruments, Inc.) · 2017

Class I recalls in this family

K072237 Magnetom Verio7 generations back · 2007
K041476 GE Signa Excite 1.5T MR System, GE Signa Excite…8 generations back · 2004
K030874 GE 3.0T Signa Infinity Twinspeed with Excite MR…9 generations back · 2003
K013636 Signa Infinity MR System with Excite Technology9 generations back · 2002

Most influential descendants

Showing 3 of 3 · See all

K18066648CH Head CoilGe Healthcare Coils (Usa Instruments, Inc.) · 2018 · cites it directly1descendant
K2537383.0T Air 32CH HnaGe Healthcare Coils (Usa Instruments, Inc.) · 2026 · 2 generations on0descendants
K183186Head Coil – 12, Head Coil – 32, Carotid Coil – 8, Temporomandibular Joint Coil – 4…Shanghai United Imaging Healthcare Co., Ltd. · 2019 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−14	K971684	Magnetom Project 047 System (Numaris 3.5 Software)	Siemens Medical Solutions USA, Inc.	1997	4
−13	K032428	Magnetom Avanto MR System	Siemens Medical Solutions USA, Inc.	2003	4
−12	K041112	Magnetom Espree System	Siemens Medical Solutions USA, Inc.	2004	4
−11	K052164	Magnetom Systems with Software Syngo MR 2006A	Siemens Medical Solutions USA, Inc.	2005	—
−10	K062454	Magnetom Systems - I-Class and T-Class Releases	Siemens Medi Cal Solutions, Inc.	2006	—
−9	K072237	Magnetom Verio	Siemens Medical Solutions USA, Inc.	2007	Class I
−8	K081028	Signa 3.0T MR750 System	Ge Medical Systems, LLC	2008	11
−7	K083147	Discovery MR450	Ge Medical Systems, LLC	2008	10
−6	K091536	Optima MR450W	Ge Medical Systems, LLC	2009	8
−5	K113490	Optima MR450W	Ge Medical Systems, LLC	2012	3
−4	K123522	Optima MR450W	Ge Healthcare (Ge Medical Systems, LLC)	2013	1
−3	K132376	Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750W 3.0T, Optima…	Ge Healthcare (Ge Medical Systems, LLC)	2013	15
−2	K142085	Discovery MR750 3.0T ,Discovery MR450 1.5T, Discovery MR750 3.0T,Optima MR450W…	Ge Medical Systems, LLC	2014	27
−1	K143345	SIGNA Pioneer	Ge Healthcare Japan Corporation	2015	6
0 (this device)	K163205	48CH Head Coil	Ge Healthcare Coils (Usa Instruments, Inc.)	2017	—
+1	K180666	48CH Head Coil	Ge Healthcare Coils (Usa Instruments, Inc.)	2018	—
+2	K253738	3.0T Air 32CH Hna	Ge Healthcare Coils (Usa Instruments, Inc.)	2026	—
+1	K183186	Head Coil – 12, Head Coil – 32, Carotid Coil – 8, Temporomandibular Joint Coil…	Shanghai United Imaging Healthcare Co., Ltd.	2019	—

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
2011	1	0
2013	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2018	1	0
2019	1	0
2026	1	0

FIG. 1 — Lineage of K163205, 1997–2026Source: 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
*	K143345	SIGNA Pioneer Summary page 4 …ic Resonance Diagnostic Device per 21 CFR 892.1000 Product Code: MOS Predicate Device(s): TDI Head Neck Unit (K143345) Device Description: The 48CH Head Coil is a phased-array receive-only coil designed to prov…	Ge Healthcare Japan Corporation	2015	6

Also cleared against K143345: 2 other devices →

What descends from it? (3)

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

Number	Device	Applicant	Decided	Descendants
K180666	48CH Head Coil	Ge Healthcare Coils (Usa Instruments, Inc.)	2018	1
K183186	Head Coil – 12, Head Coil – 32, Carotid Coil – 8, Temporomandibular Joint Coil – 4…	Shanghai United Imaging Healthcare Co., Ltd.	2019	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 · 7 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 · 8 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 · 9 generations back · ◆ in the 2003 ancestors bar of FIG. 11 Class I recall
K013636Signa Infinity MR System with Excite TechnologyGE Medical Systems · 2002 · 9 generations back · ◆ in the 2002 ancestors bar of FIG. 11 Class I recall
K0122001.5T Infinity Twinspeed MR SystemGE Medical Systems · 2001 · 10 generations back · ◆ in the 2001 ancestors bar of FIG. 11 Class I recall

What does this lineage say?

The line of descent spans 20 years and passes through 6 companies; a new generation was cleared every 11 months on median.
24 of the 31 ancestors have a recall of any class; 5 have a Class I recall.
Of its descendants, K180666 (Ge Healthcare Coils (Usa Instruments, Inc.), 2018) has gone furthest, with 1 descendant of its own.
2 other devices also cite its predicate K143345.

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. 2017, 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 48CH Head Coil is a receive-only RF coil designed for use with select 3.0T MRI systems manufactured by GE Healthcare. The coil is indicated for use for head imaging. The nucleus excited is hydrogen.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K163205 · printed Nov 4, 2026

Cite this page

510(k) Report. “K163205: 48CH Head Coil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K163205

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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