510(k) · Cleared

Cleared

Torso Array Coil, Model 558GE-64

K041185510(k) TraditionalCleared May 14, 20048-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

Igc-Medical Advances, Inc. · MOS Coil, Magnetic Resonance, Specialty

Cleared on May 14, 2004 after an 8-day review. The FDA summary names its predicate without a number. 10 later devices descend from it.

Decided: May 14, 2004
Review: 8 days
Class: Class II
Product code: MOS
Recalls: None
Predicates: 0

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

This deviceK041185 Torso Array Coil, Model 558GE-64Igc-Medical Advances, Inc. · 2004
Descendant · cites it directly · 8 of its ownK063513 Echelon MR-RCC-150 Cardiac CoilHitachi Medical Systems America, Inc. · 2006
Descendant · 2 generations on · 6 of its ownK081340 Pediatric Body and Cardiac Coil, Model 01000140201Shanghai Chenguang Medical Technologies Co, Ltd. · 2008
Descendant · 3 generations on · 5 of its ownK101949 Pediatric Body-Cardiac Coil, Model: 5000012601Shanghai Chenguang Medical Technologies Co, Ltd. · 2010
Descendant · 4 generations on · 4 of its ownK213397 InkSpace Imaging Pediatric Body ArrayInkspace Imaging, Inc. · 2021
Descendant · 5 generations on · 3 of its ownK223487 InkSpace Imaging Body ArrayInkspace Imaging, Inc. · 2022

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2006high 2 (2024) · low 0 (2009)2026

Most influential descendants

Showing 5 of 10 · See all

K063513Echelon MR-RCC-150 Cardiac CoilHitachi Medical Systems America, Inc. · 2006 · cites it directly8descendants
K081340Pediatric Body and Cardiac Coil, Model 01000140201Shanghai Chenguang Medical Technologies Co, Ltd. · 2008 · 2 generations on6descendants
K101949Pediatric Body-Cardiac Coil, Model: 5000012601Shanghai Chenguang Medical Technologies Co, Ltd. · 2010 · 3 generations on5descendants
K213397InkSpace Imaging Pediatric Body ArrayInkspace Imaging, Inc. · 2021 · 4 generations on4descendants
K223487InkSpace Imaging Body ArrayInkspace Imaging, Inc. · 2022 · 5 generations on3descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K041185	Torso Array Coil, Model 558GE-64	Igc-Medical Advances, Inc.	2004	—
+1	K063513	Echelon MR-RCC-150 Cardiac Coil	Hitachi Medical Systems America, Inc.	2006	—
+2	K081340	Pediatric Body and Cardiac Coil, Model 01000140201	Shanghai Chenguang Medical Technologies Co, Ltd.	2008	—
+3	K101949	Pediatric Body-Cardiac Coil, Model: 5000012601	Shanghai Chenguang Medical Technologies Co, Ltd.	2010	—
+4	K213397	InkSpace Imaging Pediatric Body Array	Inkspace Imaging, Inc.	2021	—
+5	K223487	InkSpace Imaging Body Array	Inkspace Imaging, Inc.	2022	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0
2007	1	0
2008	1	0
2010	1	0
2011	1	0
2021	1	0
2022	1	0
2024	2	0
2025	1	0

FIG. 1 — Lineage of K041185, 2004–2025Source: 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
*	—	Hitachi AIRIS-Elite 0.3T system Named without a submission number			—

What descends from it? (10)

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

Number	Device	Applicant	Decided	Descendants
K063513	Echelon MR-RCC-150 Cardiac Coil	Hitachi Medical Systems America, Inc.	2006	8
K073181	Neocoil 1.5T 16 Channel Cardiac-Abdominal-Pelvic Array Coil	Neocoil, LLC	2007	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, K063513 (Hitachi Medical Systems America, Inc., 2006) has gone furthest, with 8 descendants of its own.

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?

Magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA) of the musculoskeletal structures, soft tissue and vascular structures of the torso, pelvis, and abdomen.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K041185 · printed Nov 5, 2026

Cite this page

510(k) Report. “K041185: Torso Array Coil, Model 558GE-64.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041185

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