510(k) · Cleared

Cleared

GE 8CH Foot Ankle Coil

K122694510(k) TraditionalCleared Oct 25, 201251-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 Hangwei Medical Systems Co., Ltd. · MOS Coil, Magnetic Resonance, Specialty

Cleared on Oct 25, 2012 as substantially equivalent to K050514 (Mri Devices Corporation, 2005) after a 51-day review. Its family tree reaches back 1 generation to 2005. 1 later device descends from it.

Decided: Oct 25, 2012
Review: 51 days
Class: Class II
Product code: MOS
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K050514 (2005). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK050514 Models Fac-63 and Fac-127 Foot and Ankle CoilsMri Devices Corporation · 2005
This deviceK122694 GE 8CH Foot Ankle CoilGe Hangwei Medical Systems Co., Ltd. · 2012
Descendant · cites it directly · 0 of its ownK160935 8ch Foot Ankle CoilShenzhen RF Tech Co., Ltd. · 2016

Most influential descendants

Showing 1 of 1 · See all

K1609358ch Foot Ankle CoilShenzhen RF Tech Co., Ltd. · 2016 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K050514	Models Fac-63 and Fac-127 Foot and Ankle Coils	Mri Devices Corporation	2005	—
0 (this device)	K122694	GE 8CH Foot Ankle Coil	Ge Hangwei Medical Systems Co., Ltd.	2012	—
+1	K160935	8ch Foot Ankle Coil	Shenzhen RF Tech Co., Ltd.	2016	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2016	1	0

FIG. 1 — Lineage of K122694, 2005–2016Source: 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? (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
*	K050514	Models Fac-63 and Fac-127 Foot and Ankle Coils Summary page 1 …esonance, specialty Classification Names: 21CFR 892. 1000, Magnetic resonance diagnostic device Product Code: 9OMOS Predicate Device(s): K0505 14, Foot Ankle coil (MRI Devices Corporation, which known as Invivo Corporation) Device Description:…	Mri Devices Corporation	2005	—

Also cleared against K050514: 3 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K160935	8ch Foot Ankle Coil	Shenzhen RF Tech Co., Ltd.	2016	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, K160935 (Shenzhen RF Tech Co., Ltd., 2016) has gone furthest, with 0 descendants of its own.
3 other devices also cite its predicate K050514.

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?

The GE BCH Foot Ankle Coil is a receive-only RF surface coil designed for use with 1.5T MRI systems manufactured by GE Healthcare. The 8ch Foot Ankle Coil for GE 1.5T MRI systems is indicated for use for foot and ankle imaging. The nucleus excited is hydrogen.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K122694 · printed Nov 6, 2026

Cite this page

510(k) Report. “K122694: GE 8CH Foot Ankle Coil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122694

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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