510(k) · Cleared

Cleared

3.0T Torso Phased Array Coil

K030495510(k) TraditionalCleared Mar 5, 200314-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 Medical Systems, Inc. · MOS Coil, Magnetic Resonance, Specialty

Cleared on Mar 5, 2003 as substantially equivalent to K971667 (GE Medical Systems, 1997) and 1 other predicate after a 14-day review. Its family tree reaches back 1 generation to 1997. 4 later devices descend from it.

Decided: Mar 5, 2003
Review: 14 days
Class: Class II
Product code: MOS
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K971667 (1997). 2 ancestors in all. 4 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK971667 Cardiac Phased Array CoilGE Medical Systems · 1997
This deviceK030495 3.0T Torso Phased Array CoilGe Medical Systems, Inc. · 2003
Descendant · cites it directly · 3 of its ownK031209 GE 1.5T 8 Channel Torso CoilGe Medical Systems, Inc. · 2003
Descendant · 2 generations on · 1 of its ownK052584 1.5T 12 Channel Body ArrayUsa Instruments, Inc. · 2005
Descendant · 3 generations on · 0 of its ownK101492 8 Channel Cardiac Phased Array CoilGe Healthcare Coils (Usa Instruments, Inc.) · 2010
Descendant · cites it directly · 0 of its ownK073236 Neocoil 3.0T 32-Channel Torso Array Coil for GENeocoil · 2007

Most influential descendants

Showing 4 of 4 · See all

K031209GE 1.5T 8 Channel Torso CoilGe Medical Systems, Inc. · 2003 · cites it directly3descendants
K0525841.5T 12 Channel Body ArrayUsa Instruments, Inc. · 2005 · 2 generations on1descendant
K1014928 Channel Cardiac Phased Array CoilGe Healthcare Coils (Usa Instruments, Inc.) · 2010 · 3 generations on0descendants
K073236Neocoil 3.0T 32-Channel Torso Array Coil for GENeocoil · 2007 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K971667	Cardiac Phased Array Coil	GE Medical Systems	1997	—
0 (this device)	K030495	3.0T Torso Phased Array Coil	Ge Medical Systems, Inc.	2003	—
+1	K031209	GE 1.5T 8 Channel Torso Coil	Ge Medical Systems, Inc.	2003	—
+2	K052584	1.5T 12 Channel Body Array	Usa Instruments, Inc.	2005	—
+3	K101492	8 Channel Cardiac Phased Array Coil	Ge Healthcare Coils (Usa Instruments, Inc.)	2010	—
+1	K073236	Neocoil 3.0T 32-Channel Torso Array Coil for GE	Neocoil	2007	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2000	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2005	1	0
2007	1	0
2010	1	0

FIG. 1 — Lineage of K030495, 1997–2010Source: 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? (2)

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
*	K971667	Cardiac Phased Array Coil Summary page 1 …FR 892.1000,90-MOS Marketed Device: The 3.OT Torso Phased Array Coil is substantially equivalent to the currently marketed GE Medical Systems 1.5T Cardiac Phased Array (K971667) and USA Instruments Torso and Pelvis Phased Array Coil (K001209). Device Description: The 3.OT Torso Phased Array Coil is a fou…	GE Medical Systems	1997	—
*	K001209	Insight Plus 9000 Phased Array Torso and Pelvis Coil Summary page 1 …Coil is substantially equivalent to the currently marketed GE Medical Systems 1.5T Cardiac Phased Array (K971667) and USA Instruments Torso and Pelvis Phased Array Coil (K001209). Device Description: The 3.OT Torso Phased Array Coil is a four-channel phased array receive only MR coil used in conjunction w…	Usa Instruments, Inc.	2000	—

Also cleared against K971667: 1 other device →

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
K031209	GE 1.5T 8 Channel Torso Coil	Ge Medical Systems, Inc.	2003	3
K073236	Neocoil 3.0T 32-Channel Torso Array Coil for GE	Neocoil	2007	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?

None of the 2 ancestors has a recall.
Of its descendants, K031209 (Ge Medical Systems, Inc., 2003) has gone furthest, with 3 descendants of its own.
1 other device also cites its predicate K971667.

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 coil is indicated for use, on the order of a physician in conjunction with a 3.OT MR scanner, as an accessory to produce images of the abdominal and pelvic regions in 2D and 3D.

The primary applications associated with evaluation of the anatomy are as follows:

Thorax

Abdomen

Male and Female Pelvis

Prostate

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K030495 · printed Nov 3, 2026

Cite this page

510(k) Report. “K030495: 3.0T Torso Phased Array Coil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K030495

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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