510(k) · Cleared

Cleared

1.5T and 3.0T General Purpose Flex Coils

K093842510(k) TraditionalCleared Mar 5, 201080-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

Invivo Corporation · MOS Coil, Magnetic Resonance, Specialty

Cleared on Mar 5, 2010 as substantially equivalent to K954190 (Medical Advances, Inc., 1995) after an 80-day review. Its family tree reaches back 1 generation to 1995. 7 later devices descend from it.

Decided: Mar 5, 2010
Review: 80 days
Class: Class II
Product code: MOS
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K954190 (1995). 7 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK954190 Model 580GE-64 Quadrature Abdominal Flex CoilMedical Advances, Inc. · 1995
This deviceK093842 1.5T and 3.0T General Purpose Flex CoilsInvivo Corporation · 2010
Descendant · cites it directly · 5 of its ownK111673 1.5T and 3T 8-Channel Medium General Purpose Flex CoilInvivo Corporation · 2011
Descendant · cites it directly · 3 of its ownK122897 Sense Head 16 Model 800647, Sense Spine 16 Model 800646; Sense Torso…Invivo Corporation · 2012
Descendant · 2 generations on · 3 of its ownK120122 Sense MSK S 8CH 1.5TInvivo Corporation · 2012
Descendant · 2 generations on · 2 of its ownK212864 dS TorsoCardiac 1.5T, dS MSK S 1.5T, dS MSK M 1.5TPhilips Healthcare (Suzhou) Co., Ltd. · 2021
Descendant · 3 generations on · 1 of its ownK232021 Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5TPhilips Healthcare (Suzhou) Co., Ltd. · 2023

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2011high 2 (2012) · low 0 (2013)2026

Most influential descendants

Showing 5 of 7 · See all

K1116731.5T and 3T 8-Channel Medium General Purpose Flex CoilInvivo Corporation · 2011 · cites it directly5descendants
K122897Sense Head 16 Model 800647, Sense Spine 16 Model 800646; Sense Torso 16 Model 800645Invivo Corporation · 2012 · cites it directly3descendants
K120122Sense MSK S 8CH 1.5TInvivo Corporation · 2012 · 2 generations on3descendants
K212864dS TorsoCardiac 1.5T, dS MSK S 1.5T, dS MSK M 1.5TPhilips Healthcare (Suzhou) Co., Ltd. · 2021 · 2 generations on2descendants
K232021Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5TPhilips Healthcare (Suzhou) Co., Ltd. · 2023 · 3 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K954190	Model 580GE-64 Quadrature Abdominal Flex Coil	Medical Advances, Inc.	1995	—
0 (this device)	K093842	1.5T and 3.0T General Purpose Flex Coils	Invivo Corporation	2010	—
+1	K111673	1.5T and 3T 8-Channel Medium General Purpose Flex Coil	Invivo Corporation	2011	—
+1	K122897	Sense Head 16 Model 800647, Sense Spine 16 Model 800646; Sense Torso 16 Model…	Invivo Corporation	2012	—
+2	K120122	Sense MSK S 8CH 1.5T	Invivo Corporation	2012	—
+2	K212864	dS TorsoCardiac 1.5T, dS MSK S 1.5T, dS MSK M 1.5T	Philips Healthcare (Suzhou) Co., Ltd.	2021	—
+3	K232021	Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T	Philips Healthcare (Suzhou) Co., Ltd.	2023	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	1	0
2012	2	0
2014	1	0
2021	1	0
2023	1	0
2026	1	0

FIG. 1 — Lineage of K093842, 1995–2026Source: 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
*	K954190	Model 580GE-64 Quadrature Abdominal Flex Coil Summary page 1 …been altered from the predicate device. Substantial Equivalence Information: When compared to the predicate device, l.OT/1.5T/0.5T GE Quad/Phase Array Abdominal Coil - K954190, cleared 11/20/95, substantial equivalence is based on similarities in design features, overall indications for use, and technolo…	Medical Advances, Inc.	1995	—

Also cleared against K954190: 1 other device →

What descends from it? (7)

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

Number	Device	Applicant	Decided	Descendants
K111673	1.5T and 3T 8-Channel Medium General Purpose Flex Coil	Invivo Corporation	2011	5
K122897	Sense Head 16 Model 800647, Sense Spine 16 Model 800646; Sense Torso 16 Model 800645	Invivo Corporation	2012	3

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, K111673 (Invivo Corporation, 2011) has gone furthest, with 5 descendants of its own.
1 other device also cites its predicate K954190.

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. 2010, 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 coil is indicated for use on the order of a physician, in conjunction with Philips 1.5T and 3.0T MR scanners as an accessory to produce images of the hip, knee, ankle, chest, and pelvic regions, as an aid to diagnosis.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K093842 · printed Nov 6, 2026

Cite this page

510(k) Report. “K093842: 1.5T and 3.0T General Purpose Flex Coils.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093842

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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