510(k) · Cleared

Cleared

1.5T 4CH Large Flex Coil, 1.5 4CH Small Flex Coil

K123681510(k) TraditionalCleared Feb 22, 201384-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

Wipro GE Healthcare Private, Ltd. · MOS Coil, Magnetic Resonance, Specialty

Cleared on Feb 22, 2013 as substantially equivalent to K030953 (Ge Medical Systems, Inc., 2003) after an 84-day review. Its family tree reaches back 2 generations to 1992.

Decided: Feb 22, 2013
Review: 84 days
Class: Class II
Product code: MOS
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K923264 (1992). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK923264 General Purpose Flex CoilGeneral Electric Co. · 1992
1 generation backK030953 GE 3.0T General Purpose Flex CoilGe Medical Systems, Inc. · 2003
This deviceK123681 1.5T 4CH Large Flex Coil, 1.5 4CH Small Flex CoilWipro GE Healthcare Private, Ltd. · 2013

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K923264	General Purpose Flex Coil	General Electric Co.	1992	—
−1	K030953	GE 3.0T General Purpose Flex Coil	Ge Medical Systems, Inc.	2003	—
0 (this device)	K123681	1.5T 4CH Large Flex Coil, 1.5 4CH Small Flex Coil	Wipro GE Healthcare Private, Ltd.	2013	—

FIG. 1 — Lineage of K123681, 1992–2013Source: 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
*	K030953	GE 3.0T General Purpose Flex Coil Summary page 1 …sonance, specialty Classification Names: 2I1CFR 892. 1000, Magnetic resonance diagnostic device Product Code: MOS Predicate Device(s): K030953, GE 3.OT General Purpose Flex Coil Device Description: The I.5T 4CH Flex Coils are receive-only coils designed…	Ge Medical Systems, Inc.	2003	—

Also cleared against K030953: 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 21 years and passes through 3 companies; a new generation was cleared every 10.5 years on median.
None of the 2 ancestors has a recall.
1 other device also cites its predicate K030953.

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. 2013, 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 Flex Coils are designed to produce diagnostic images of human anatomnies and are used as general purpose coils. The Flex Coils are receive-only coils designed to be used with 1.5T MRI systems manufactured by GE Healthcare to provide images of various parts of human body including shoulder, elbow, wrist, knee, hip and ankle. Large flex coil can be used for scanning large anatomy and small flex coil can be used for scanning smaller anatomy. The flexible coil is wrapped around the anatomy of interest, such as an elbow or knee or can be used for planar imaging.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K123681 · printed Nov 6, 2026

Cite this page

510(k) Report. “K123681: 1.5T 4CH Large Flex Coil, 1.5 4CH Small 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/K123681

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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