510(k) · Cleared

Cleared

1.5T Gem Flex Coil

K113474510(k) AbbreviatedCleared Mar 16, 2012115-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, LLC · MOS Coil, Magnetic Resonance, Specialty

Cleared on Mar 16, 2012 as substantially equivalent to K101632 (Neocoil, LLC, 2010) after a 115-day review. Its family tree reaches back 1 generation to 2010. 6 later devices descend from it.

Decided: Mar 16, 2012
Review: 115 days
Class: Class II
Product code: MOS
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K101632 (2010). 6 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK101632 MetaflexcoilNeocoil, LLC · 2010
This deviceK113474 1.5T Gem Flex CoilNeocoil, LLC · 2012
Descendant · cites it directly · 4 of its ownK121362 1.5T 16CH Flex Speeder LargeNeocoil, LLC · 2012
Descendant · cites it directly · 0 of its ownK252179 GEM Flex Coil 16-L Array, 1.5T Receive Only; GEM Flex Coil 16-M…Shenzhen RF Tech Co., Ltd. · 2026
Descendant · 2 generations on · 0 of its ownK244054 16ch Flex SPEEDER Medium 1.5T (Q7000246); 16ch Flex SPEEDER Large…Quality Electrodynamics · 2025
Descendant · 2 generations on · 0 of its ownK141832 3T 16CH Flex Speeder, Medium , 3T 16CH Flex Speeder, LargeNeocoil, LLC · 2014 · Recalled
Descendant · 2 generations on · 0 of its ownK133422 1.5T 16-Channel Flex Coil, Small 1.5T 16-Channel Flex Coil, LargeNeocoil, LLC · 2013

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2012high 2 (2013) · low 0 (2015)2026

Most influential descendants

Showing 5 of 6 · See all

K1213621.5T 16CH Flex Speeder LargeNeocoil, LLC · 2012 · cites it directly4descendants
K252179GEM Flex Coil 16-L Array, 1.5T Receive Only; GEM Flex Coil 16-M Array, 1.5T Receive…Shenzhen RF Tech Co., Ltd. · 2026 · cites it directly0descendants
K24405416ch Flex SPEEDER Medium 1.5T (Q7000246); 16ch Flex SPEEDER Large 1.5T (Q7000247)Quality Electrodynamics · 2025 · 2 generations on0descendants
K1418323T 16CH Flex Speeder, Medium , 3T 16CH Flex Speeder, LargeNeocoil, LLC · 2014 · 2 generations on0descendants
K1334221.5T 16-Channel Flex Coil, Small 1.5T 16-Channel Flex Coil, LargeNeocoil, LLC · 2013 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K101632	Metaflexcoil	Neocoil, LLC	2010	—
0 (this device)	K113474	1.5T Gem Flex Coil	Neocoil, LLC	2012	—
+1	K121362	1.5T 16CH Flex Speeder Large	Neocoil, LLC	2012	—
+1	K252179	GEM Flex Coil 16-L Array, 1.5T Receive Only; GEM Flex Coil 16-M Array, 1.5T…	Shenzhen RF Tech Co., Ltd.	2026	—
+2	K244054	16ch Flex SPEEDER Medium 1.5T (Q7000246); 16ch Flex SPEEDER Large 1.5T…	Quality Electrodynamics	2025	—
+2	K141832	3T 16CH Flex Speeder, Medium , 3T 16CH Flex Speeder, Large	Neocoil, LLC	2014	1
+2	K133422	1.5T 16-Channel Flex Coil, Small 1.5T 16-Channel Flex Coil, Large	Neocoil, LLC	2013	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2012	1	0
2013	2	0
2014	1	0
2025	1	0
2026	1	0

FIG. 1 — Lineage of K113474, 2010–2026Source: 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.

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? (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
*	K101632	Metaflexcoil Summary page 1 …ding to the proton precession in a 1.5 tesla magnetic field, which is governed by the Larmor equation. 5.7. Predicate Device 1S5T MetaFlexCoil (K101632) 5.8. Comparison to Predicate The NecCoil 1.5T GEM Flex Coil is identical in physical, performance, design and materia…	Neocoil, LLC	2010	—

Also cleared against K101632: 1 other device →

What descends from it? (6)

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

Number	Device	Applicant	Decided	Descendants
K121362	1.5T 16CH Flex Speeder Large	Neocoil, LLC	2012	4
K252179	GEM Flex Coil 16-L Array, 1.5T Receive Only; GEM Flex Coil 16-M Array, 1.5T Receive…	Shenzhen RF Tech Co., Ltd.	2026	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?

Its one ancestor has no recall.
Of its descendants, K121362 (Neocoil, LLC, 2012) has gone furthest, with 4 descendants of its own.
1 other device also cites its predicate K101632.

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. 2012, 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?

To be used in conjunction with a GE 1.5 HD or DV Series Magnetic Resonance Scanner to produce diagnostic images of the upper and lower extremities, chest, abdomen, pelvis, head, neck, and spine in pediatric and adult populations that can be interpreted by a trained physician.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K113474 · printed Nov 6, 2026

Cite this page

510(k) Report. “K113474: 1.5T Gem Flex Coil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113474

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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