510(k) · Cleared

Cleared

MC 1504G-16R, 1.5T, 16-Channel, MC 3004G-16R, 3.0T, 16-Channel Head Coil

K110591510(k) TraditionalCleared Mar 29, 201127-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 Mar 29, 2011 as substantially equivalent to K013159 (Mri Devices Corp., 2001) and 1 other predicate after a 27-day review. Its family tree reaches back 1 generation to 2001.

Decided: Mar 29, 2011
Review: 27 days
Class: Class II
Product code: MOS
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K013159 (2001). 2 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK013159 HRH-63-8 Head Array CoilMri Devices Corp. · 2001
This deviceK110591 MC 1504G-16R, 1.5T, 16-Channel, MC 3004G-16R, 3.0T, 16-Channel Head…Mr Instruments, Inc. · 2011

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K013159	HRH-63-8 Head Array Coil	Mri Devices Corp.	2001	—
0 (this device)	K110591	MC 1504G-16R, 1.5T, 16-Channel, MC 3004G-16R, 3.0T, 16-Channel Head Coil	Mr Instruments, Inc.	2011	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0

FIG. 1 — Lineage of K110591, 2001–2011Source: 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
*	K013159	HRH-63-8 Head Array Coil Summary page 1 …(21 CFR 892.1000, Product Code MOS) Predicate Device: HRH-63-8, 1.5T, 8-Channel Head Array, MRI Devices (K0131 59) HRH-127-8, 3.OT, 8-Channel Head Array, MRI Devices (K022372) M…	Mri Devices Corp.	2001	—
*	K022372	HRH-127-8 Head Array Coil Summary page 1 …MRI Devices (K0131 59) HRH-127-8, 3.OT, 8-Channel Head Array, MRI Devices (K022372) Manufacturer: MR Instruments, Inc. 5610 Rowland Road, Suite 145…	Mri Devices Corp.	2002	—

Also cleared against K013159: 3 other devices →

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?

None of the 2 ancestors has a recall.
3 other devices also cite its predicate K013159.

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. 2011, 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?

This coil is indicate for use in conjunction with 1.5T and 3.0T GE Healthcare Magnetic Resonance Scanner systems to produce images and/or spectra of the head, that when interpreted by a trained physician yield information that may assist in diagnosis.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K110591 · printed Nov 6, 2026

Cite this page

510(k) Report. “K110591: MC 1504G-16R, 1.5T, 16-Channel, MC 3004G-16R, 3.0T, 16-Channel 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/K110591

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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