510(k) · Cleared

Cleared

Signa Breast Coil and Array Accessory

K923025510(k) TraditionalCleared Nov 27, 1992157-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 Medical Systems · LNH System, Nuclear Magnetic Resonance Imaging

Cleared on Nov 27, 1992 after a 157-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 9 later devices descend from it.

Decided: Nov 27, 1992
Review: 157 days
Class: Class II
Product code: LNH
Recalls: None
Predicates: 0

9 later devices descend from it, 3 citing it directly.

This deviceK923025 Signa Breast Coil and Array AccessoryGE Medical Systems · 1992
Descendant · cites it directly · 6 of its ownK960901 Medrad Phased Array 1.5T Shoulder Imaging Surface CoilMedrad, Inc. · 1996
Descendant · 2 generations on · 3 of its ownK984257 Medrad Phased Array Neurovascular CoilMedrad, Inc. · 1999
Descendant · 3 generations on · 2 of its ownK023596 Medrad 8-Receiver Phased Array Neurovascular CoilMedrad, Inc. · 2002
Descendant · 4 generations on · 0 of its ownK093689 1.5 Tesla 16- Channel Receive-Only Phased- Array Head Coil for SiemansMr Medical Solutions, LLC · 2010
Descendant · 4 generations on · 0 of its ownK052827 Modification to Medrad 8-Receiver Phased Array Neurovascular Coil…Medrad, Inc. · 2005

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

1996high 2 (1998) · low 0 (2000)2026

Most influential descendants

Showing 5 of 9 · See all

K960901Medrad Phased Array 1.5T Shoulder Imaging Surface CoilMedrad, Inc. · 1996 · cites it directly6descendants
K984257Medrad Phased Array Neurovascular CoilMedrad, Inc. · 1999 · 2 generations on3descendants
K023596Medrad 8-Receiver Phased Array Neurovascular CoilMedrad, Inc. · 2002 · 3 generations on2descendants
K0936891.5 Tesla 16- Channel Receive-Only Phased- Array Head Coil for SiemansMr Medical Solutions, LLC · 2010 · 4 generations on0descendants
K052827Modification to Medrad 8-Receiver Phased Array Neurovascular Coil for SiemensMedrad, Inc. · 2005 · 4 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K923025	Signa Breast Coil and Array Accessory	GE Medical Systems	1992	—
+1	K960901	Medrad Phased Array 1.5T Shoulder Imaging Surface Coil	Medrad, Inc.	1996	—
+2	K984257	Medrad Phased Array Neurovascular Coil	Medrad, Inc.	1999	—
+3	K023596	Medrad 8-Receiver Phased Array Neurovascular Coil	Medrad, Inc.	2002	—
+4	K093689	1.5 Tesla 16- Channel Receive-Only Phased- Array Head Coil for Siemans	Mr Medical Solutions, LLC	2010	—
+4	K052827	Modification to Medrad 8-Receiver Phased Array Neurovascular Coil for Siemens	Medrad, Inc.	2005	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0
1997	1	0
1998	2	0
1999	2	0
2002	1	0
2005	1	0
2010	1	0

FIG. 1 — Lineage of K923025, 1992–2010Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LNH? 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 LNH device

#1 K213693 MAGNETOM Vida with syngo MR XA50Ascore 23.0 · 18 generations · no Class I recall
#2 Held for the reportin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (9)

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

Number	Device	Applicant	Decided	Descendants
K960901	Medrad Phased Array 1.5T Shoulder Imaging Surface Coil	Medrad, Inc.	1996	6
K982921	Medrad 0.5T, 1.0T & 1.5T Breast Coil, Models M21BRC, M42BRA, M64BRA	Medrad, Inc.	1998	0
K982919	Medrad Quad T/L Coil (1.5T, 1.0T & 0.5T) Models M64TLC, M42TLC, M21TLC	Medrad, Inc.	1998	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?

Of its descendants, K960901 (Medrad, Inc., 1996) has gone furthest, with 6 descendants of its own.

How does its category compare?

All LNH devices

LNH System, Nuclear Magnetic Resonance Imaging: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LNH

26in 2025

2007high 32 (2020) · low 12 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LNH

122in 2025

2007high 140 (2015) · low 35 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LNH

8in 2025

2007high 71 (2018) · low 0 (2017)2026

Class I (8 since 2007) Class II/III not classified

Adverse event reports per year · LNH

1,263in 2025

2007high 1,263 (2025) · low 84 (2021)2025

MAUDE reports naming product code LNH, 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	12	35	25	114
2008	19	53	12	167
2009	17	70	7	194
2010	12	94	17	165
2011	16	81	11	182
2012	22	89	5	170
2013	19	108	2	107
2014	17	108	13	119
2015	19	140	12 (2)	113
2016	20	108	1	135
2017	18	98	0	121
2018	29	128	71	158
2019	26	62	5	158
2020	32	121	4	98
2021	27	87	41	84
2022	30	74	13	138
2023	30	124	10 (1)	159
2024	26	104	4	281
2025	26	122	8 (5)	1,263
2026	24	126	43	—

https://510kreport.com/device/K923025 · printed Nov 5, 2026

Cite this page

510(k) Report. “K923025: Signa Breast Coil and Array Accessory.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K923025

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026