510(k) · Cleared

Recalled · Class III · 2020

1.5T 16-Channel Hand-Wrist Coil

K103149510(k) TraditionalCleared Jan 3, 201170-day reviewClass II21 CFR 892.1000Recalls 1

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 Jan 3, 2011 as substantially equivalent to K050622 (Mri Devices Corporation, 2005) after a 70-day review. Its family tree reaches back 1 generation to 2005. 4 later devices descend from it. It has been recalled once.

Decided: Jan 3, 2011
Review: 70 days
Class: Class II
Product code: MOS
Recalls: 1
Predicates: 1

Its longest line of descent runs back 1 generation to K050622 (2005). 4 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK050622 HRW-63-8 Wrist Array Coil; HRW-127-8 Wrist Array CoilMri Devices Corporation · 2005
This deviceK103149 1.5T 16-Channel Hand-Wrist CoilInvivo Corporation · 2011
Descendant · cites it directly · 1 of its ownK213766 dS FootAnkle 16Ch Coils for 1.5T and 3.0T, dS HiRes HandWrist 16Ch…Invivo Corporation · 2021
Descendant · cites it directly · 1 of its ownK162623 16ch T/R Hand Wrist CoilQuality Electrodynamics, LLC · 2016
Descendant · 2 generations on · 0 of its ownK262294 dS FootAnkle 16Ch 1.5T;dS FootAnkle 16Ch 3.0T;dS HiRes Hand/Wrist…Philips Medical Systems Nederland B.V. · 2026
Descendant · 2 generations on · 0 of its ownK173469 16ch T/R Hand Wrist CoilQuality Electrodynamics, LLC · 2018

Most influential descendants

Showing 4 of 4 · See all

K213766dS FootAnkle 16Ch Coils for 1.5T and 3.0T, dS HiRes HandWrist 16Ch Coils for 1.5T and…Invivo Corporation · 2021 · cites it directly1descendant
K16262316ch T/R Hand Wrist CoilQuality Electrodynamics, LLC · 2016 · cites it directly1descendant
K262294dS FootAnkle 16Ch 1.5T;dS FootAnkle 16Ch 3.0T;dS HiRes Hand/Wrist 16Ch 1.5T;dS HiRes…Philips Medical Systems Nederland B.V. · 2026 · 2 generations on0descendants
K17346916ch T/R Hand Wrist CoilQuality Electrodynamics, LLC · 2018 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K050622	HRW-63-8 Wrist Array Coil; HRW-127-8 Wrist Array Coil	Mri Devices Corporation	2005	—
0 (this device)	K103149	1.5T 16-Channel Hand-Wrist Coil	Invivo Corporation	2011	—
+1	K213766	dS FootAnkle 16Ch Coils for 1.5T and 3.0T, dS HiRes HandWrist 16Ch Coils for…	Invivo Corporation	2021	—
+1	K162623	16ch T/R Hand Wrist Coil	Quality Electrodynamics, LLC	2016	—
+2	K262294	dS FootAnkle 16Ch 1.5T;dS FootAnkle 16Ch 3.0T;dS HiRes Hand/Wrist 16Ch 1.5T;dS…	Philips Medical Systems Nederland B.V.	2026	—
+2	K173469	16ch T/R Hand Wrist Coil	Quality Electrodynamics, LLC	2018	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2016	1	0
2018	1	0
2021	1	0
2026	1	0

FIG. 1 — Lineage of K103149, 2005–2026Source: 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

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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
*	K050622	HRW-63-8 Wrist Array Coil; HRW-127-8 Wrist Array Coil Summary page 1 …submission has not been altered from the predicate device. Substantial Equivalence Information: When compared to the predicate device, 1.5T 8-Channel Hand-Wrist Coil - K050622, cleared 04/08/05, substantial equivalence is based on similarities in design features, overall indications for use, and technolo…	Mri Devices Corporation	2005	—

Also cleared against K050622: 3 other devices →

What descends from it? (4)

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

Number	Device	Applicant	Decided	Descendants
K213766	dS FootAnkle 16Ch Coils for 1.5T and 3.0T, dS HiRes HandWrist 16Ch Coils for 1.5T and…	Invivo Corporation	2021	1
K162623	16ch T/R Hand Wrist Coil	Quality Electrodynamics, LLC	2016	1

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Sep 14, 2020	Class III	Z-0126-2021	Labeling Change Control	The labels have been mistakenly printed with an IPX1 rating symbol. IPX ratings relate to protections that products have from water ingress.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K213766 (Invivo Corporation, 2021) has gone furthest, with 1 descendant of its own.
3 other devices also cite its predicate K050622.

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. 2011, 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 GE 1.5T MR scanners as an accessory to produce images of the wrist and hand regions, as an aid to diagnosis.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K103149 · printed Nov 3, 2026

Cite this page

510(k) Report. “K103149: 1.5T 16-Channel Hand-Wrist Coil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K103149

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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