510(k) · Cleared

Cleared

Sense Body Coil

K031095510(k) TraditionalCleared Jun 20, 200374-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 (Cleveland), Inc. · MOS Coil, Magnetic Resonance, Specialty

Cleared on Jun 20, 2003 as substantially equivalent to K984588 (Philips Medical Systems (Cleveland), Inc., 1999) after a 74-day review. Its family tree reaches back 3 generations to 1995.

Decided: Jun 20, 2003
Review: 74 days
Class: Class II
Product code: MOS
Recalls: None
Predicates: 1

Its longest line of descent runs back 3 generations to K954190 (1995). No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK954190 Model 580GE-64 Quadrature Abdominal Flex CoilMedical Advances, Inc. · 1995
2 generations backK962117 Quadrature and Phased Array Flexible Body CoilsPhilips Medical Systems (Cleveland), Inc. · 1996
1 generation backK984588 Phased Array Flexible Cardiac CoilPhilips Medical Systems (Cleveland), Inc. · 1999
This deviceK031095 Sense Body CoilPhilips Medical Systems (Cleveland), Inc. · 2003

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K954190	Model 580GE-64 Quadrature Abdominal Flex Coil	Medical Advances, Inc.	1995	—
−2	K962117	Quadrature and Phased Array Flexible Body Coils	Philips Medical Systems (Cleveland), Inc.	1996	—
−1	K984588	Phased Array Flexible Cardiac Coil	Philips Medical Systems (Cleveland), Inc.	1999	—
0 (this device)	K031095	Sense Body Coil	Philips Medical Systems (Cleveland), Inc.	2003	—

FIG. 1 — Lineage of K031095, 1995–2003Source: 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
*	K984588	Phased Array Flexible Cardiac Coil Summary page 2 …standard body coil. 4. Safety and Effectiveness The Philips SENSE Body Coil is substantially equivalent to the Philips Phased Array Flexible Cardiac Coil (K984588) in safety and effectiveness. The following chart has been compiled to demonstrate this equivalence. Paramet…	Philips Medical Systems (Cleveland), Inc.	1999	—

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 8 years and passes through 2 companies; a new generation was cleared every 2.5 years on median.
None of the 3 ancestors has a recall.

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 SENSE Body Coil does not change the intended use of the Philips 1.5T Infinion system. The 1.5T Infinion system is intended for use as a NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon NMR parameters (proton density, flow velocity, spin-lattice relaxation time T1, spin-spin relaxation time T2) and (3) display the soft tissue structure of the head and whole body. When interpreted by a…

Read the full statement (119 words)

The SENSE Body Coil does not change the intended use of the Philips 1.5T Infinion system.

The 1.5T Infinion system is intended for use as a NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon NMR parameters (proton density, flow velocity, spin-lattice relaxation time T1, spin-spin relaxation time T2) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.

The SENSE Body Coil is indicated for use in the following anatomic regions and with the designated nuclei:

Anatomic Regions: Abdominal, pelvic and thoracic regions

Nuclei Excited: Hydrogen.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K031095 · printed Nov 5, 2026

Cite this page

510(k) Report. “K031095: Sense Body Coil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K031095

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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