510(k) · Cleared

Cleared

Philips Endo-Cavitary Mri Coil

K930193510(k) TraditionalCleared Jun 24, 1994526-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

Philips Medical Systems, Inc. · LNH System, Nuclear Magnetic Resonance Imaging

Cleared on Jun 24, 1994 after a 526-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.

Decided: Jun 24, 1994
Review: 526 days
Class: Class II
Product code: LNH
Recalls: None
Predicates: 0

2 later devices descend from it, 2 citing it directly.

This deviceK930193 Philips Endo-Cavitary Mri CoilPhilips Medical Systems, Inc. · 1994
Descendant · cites it directly · 1 of its ownK981410 Hammersmith Endocavitary CoilsPhilips Medical Systems (Cleveland), Inc. · 1998
Descendant · cites it directly · 0 of its ownK011683 Nurvo 9000 Endocavitary CoilsUsa Instruments, Inc. · 2001

Most influential descendants

Showing 2 of 2 · See all

K981410Hammersmith Endocavitary CoilsPhilips Medical Systems (Cleveland), Inc. · 1998 · cites it directly1descendant
K011683Nurvo 9000 Endocavitary CoilsUsa Instruments, Inc. · 2001 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K930193	Philips Endo-Cavitary Mri Coil	Philips Medical Systems, Inc.	1994	—
+1	K981410	Hammersmith Endocavitary Coils	Philips Medical Systems (Cleveland), Inc.	1998	—
+1	K011683	Nurvo 9000 Endocavitary Coils	Usa Instruments, Inc.	2001	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0
2001	1	0

FIG. 1 — Lineage of K930193, 1994–2001Source: 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

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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? (2)

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

Number	Device	Applicant	Decided	Descendants
K981410	Hammersmith Endocavitary Coils	Philips Medical Systems (Cleveland), Inc.	1998	1
K011683	Nurvo 9000 Endocavitary Coils	Usa Instruments, Inc.	2001	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, K981410 (Philips Medical Systems (Cleveland), Inc., 1998) has gone furthest, with 1 descendant 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/K930193 · printed Nov 4, 2026

Cite this page

510(k) Report. “K930193: Philips Endo-Cavitary Mri Coil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K930193

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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