510(k) · Cleared

Cleared

Neocoil 3.0T 32-Channel Torso Array Coil for GE

K073236510(k) TraditionalCleared Nov 30, 200714-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

Neocoil · MOS Coil, Magnetic Resonance, Specialty

Cleared on Nov 30, 2007 as substantially equivalent to K030495 (Ge Medical Systems, Inc., 2003) and 1 other predicate after a 14-day review. Its family tree reaches back 3 generations to 1997.

Decided: Nov 30, 2007
Review: 14 days
Class: Class II
Product code: MOS
Recalls: None
Predicates: 2

Its longest line of descent runs back 3 generations to K971667 (1997). 6 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK971667 Cardiac Phased Array CoilGE Medical Systems · 1997
2 generations backK022669 8 Channel Cardiac Phased Array CoilGE Medical Systems · 2002
1 generation backK031209 GE 1.5T 8 Channel Torso CoilGe Medical Systems, Inc. · 2003
This deviceK073236 Neocoil 3.0T 32-Channel Torso Array Coil for GENeocoil · 2007

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K971667	Cardiac Phased Array Coil	GE Medical Systems	1997	—
−2	K022669	8 Channel Cardiac Phased Array Coil	GE Medical Systems	2002	—
−1	K031209	GE 1.5T 8 Channel Torso Coil	Ge Medical Systems, Inc.	2003	—
0 (this device)	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
2001	1	0
2003	1	0

FIG. 1 — Lineage of K073236, 1997–2007Source: 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

Get a 510(k) Report

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
*	K030495	3.0T Torso Phased Array Coil Summary page 2 …Page 26 of 112 elements compared to 12. It also operates at 3.OT like the GE 3.OT Torso Phased Array Coil (K030495) instead of 1.5T. Summary of Studies: Testing was performed to demonstrate to that the design of the NeoCoil 3.OT…	Ge Medical Systems, Inc.	2003	—
*	K031209	GE 1.5T 8 Channel Torso Coil Summary page 1 …Coil (KO031209) Comparison to Predicate: The NeoCoji 3.OT 32-Channel Torso Array Coil is most similar to the GE I1.5T 8 Channel Torso Coil (K031209) with the main differences being the number of elements and the field strength. The NeoCoil Torso Coil…	Ge Medical Systems, Inc.	2003	—

Also cleared against K030495: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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 10 years and passes through 3 companies; a new generation was cleared every 4.5 years on median.
None of the 6 ancestors has a recall.
1 other device also cites its predicate K030495.

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. 2007, 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 NeoCoil 3.OT 32-Channel Torso Array Coil is intended to be used in the abdomen, pelvis, and chest regions for 2D and 3D magnetic resonance imaging and parallel body imaging for use on 3.OT GE HD series Magnetic Resonance scanners.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K073236 · printed Nov 6, 2026

Cite this page

510(k) Report. “K073236: Neocoil 3.0T 32-Channel Torso Array Coil for GE.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073236

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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