510(k) · Cleared

Cleared

Signa SP Crown Coils (Numbers 1 Through 3)

K964969510(k) TraditionalCleared Jun 26, 1997196-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 · MOS Coil, Magnetic Resonance, Specialty

Cleared on Jun 26, 1997 as substantially equivalent to K942604 (GE Medical Systems, 1995) after a 196-day review. Its family tree reaches back 1 generation to 1995.

Decided: Jun 26, 1997
Review: 196 days
Class: Class II
Product code: MOS
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K942604 (1995). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK942604 Signa Advantage SP Magnetic Resonance SystemGE Medical Systems · 1995 · Recalled
This deviceK964969 Signa SP Crown Coils (Numbers 1 Through 3)GE Medical Systems · 1997

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K942604	Signa Advantage SP Magnetic Resonance System	GE Medical Systems	1995	1
0 (this device)	K964969	Signa SP Crown Coils (Numbers 1 Through 3)	GE Medical Systems	1997	—

FIG. 1 — Lineage of K964969, 1995–1997Source: 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
*	K942604	Signa Advantage SP Magnetic Resonance System Summary page 1 …re substantially equivalent with respect to materials and operation to the presently marketed transmit/receive flexible surface coil contained in the Signa SP MR System (K942604) and are similar in utility and general coil type (solenoid) to the 0.2T Extremity Coil (K954353). /C DEPARTMENT…	GE Medical Systems	1995	1
†	K954353	Magnetic Resonance Diagnostic Accessory	General Electric Co.	1996	—

Also cleared against K942604: 2 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?

Its one ancestor has a recall.
2 other devices also cite its predicate K942604.

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.

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 Signa SP Crown Coil family provides imaging capability for the Signa SP MR System by facilitating magnetic resonance imaging of the head and extremities and providing a mechanism for dynamic (i.e., flexion of joints) magnetic resonance imaging of the extremities.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K964969 · printed Nov 6, 2026

Cite this page

510(k) Report. “K964969: Signa SP Crown Coils (Numbers 1 Through 3).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K964969

Report an extraction error

Are you the manufacturer?

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