510(k) · Cleared

Cleared

Tem 3000 Head Coil

K052200510(k) TraditionalCleared Aug 19, 20057-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

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

Cleared on Aug 19, 2005 as substantially equivalent to K040444 (General Electric Co., 2004) after a 7-day review. Its family tree reaches back 3 generations to 1999. 1 of the 5 devices in its family, counting itself, has a Class I recall.

Decided: Aug 19, 2005
Review: 7 days
Class: Class II
Product code: MOS
Recalls: None
Predicates: 1

Its longest line of descent runs back 3 generations to K990550 (1999). 4 ancestors in all. No later device cites it as a predicate yet. 1 of the 5 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 3 generations backK990550 3.0T Signa VH/I Magnetic Resonance SystemGe Medical Systems, Inc. · 1999
2 generations backK022397 Signa 3.0T Magnetic Resonance SystemGE Medical Systems · 2002 · Recalled
1 generation backK040444 GE Signa 3.0T with Excite MR SystemGeneral Electric Co. · 2004 · Recalled (Class I)
This deviceK052200 Tem 3000 Head CoilMr Instruments, Inc. · 2005

Class I recalls in this family

K040444 GE Signa 3.0T with Excite MR Systemdirect predicate · 2004

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K990550	3.0T Signa VH/I Magnetic Resonance System	Ge Medical Systems, Inc.	1999	—
−2	K022397	Signa 3.0T Magnetic Resonance System	GE Medical Systems	2002	1
−1	K040444	GE Signa 3.0T with Excite MR System	General Electric Co.	2004	Class I
0 (this device)	K052200	Tem 3000 Head Coil	Mr Instruments, Inc.	2005	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0

FIG. 1 — Lineage of K052200, 1999–2005Source: 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.

1 device in this family has 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

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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
*	K040444	GE Signa 3.0T with Excite MR System Summary page 1 …Milwaukee, WI (USA) by GE Medical Systems (India) Private LTD, coil. The TEM Assembly for G3 (K040444), is also quadrature transmit/receive above) is similar…	General Electric Co.	2004	Class I

Also cleared against K040444: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (1 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.

K040444GE Signa 3.0T with Excite MR SystemGeneral Electric Co. · 2004 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall

What does this lineage say?

The line of descent spans 6 years and passes through 4 companies; a new generation was cleared every 1.6 years on median.
2 of the 4 ancestors have a recall of any class; 1 has a Class I recall.
1 other device also cites its predicate K040444.

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 MR Instruments TEM 3000G Head Coil is designed to provide Magnetic Resonance Images of the brain, soft tissues and vasculature of the head. The TEM 3000G Head Coil is designed for use with the GE Signa 3.0T Excite MR System manufactured by GE.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K052200 · printed Nov 6, 2026

Cite this page

510(k) Report. “K052200: Tem 3000 Head Coil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052200

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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