510(k) · Cleared

Cleared

1.5 T/R Quad Extremity Coil, 1.5T 8CH T/R Knee Coil

K222257510(k) TraditionalCleared Aug 23, 202227-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 (Business Trade Name: Philips) · MOS Coil, Magnetic Resonance, Specialty

Cleared on Aug 23, 2022 as substantially equivalent to K934396 (Medical Advances, Inc., 1993) and 1 other predicate after a 27-day review. Its family tree reaches back 1 generation to 1993.

Decided: Aug 23, 2022
Review: 27 days
Class: Class II
Product code: MOS
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K934396 (1993). 2 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK934396 Quadrature Lower Extremity CoilMedical Advances, Inc. · 1993
This deviceK222257 1.5 T/R Quad Extremity Coil, 1.5T 8CH T/R Knee CoilInvivo Corporation (Business Trade Name: Philips) · 2022

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K934396	Quadrature Lower Extremity Coil	Medical Advances, Inc.	1993	—
0 (this device)	K222257	1.5 T/R Quad Extremity Coil, 1.5T 8CH T/R Knee Coil	Invivo Corporation (Business Trade Name: Philips)	2022	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0

FIG. 1 — Lineage of K222257, 1993–2022Source: 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? (2)

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
*	K934396	Quadrature Lower Extremity Coil Summary page 4 …Panel – Radiology Device Class – Class II Product Code – MOS Predicate Device: Quadrature Lower Extremity Coil, K934396, cleared November 24, 1993 Predicate Device Classification Name – Coil, Magnetic Resonance, Specialty Classification:…	Medical Advances, Inc.	1993	—
*	K032633	HRK-63-8 Knee Array Coil Summary page 4 …ication Panel – Radiology Device Class – Class II Product Code – MOS Predicate Device: HRK‐63‐8 Knee Array Coil, K032633, cleared September 25, 2003 Predicate Device Classification Name – Coil, Magnetic Resonance, Specialty Classification:…	Mri Devices Corp.	2003	—

Also cleared against K934396: 2 other devices →

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?

None of the 2 ancestors has a recall.
2 other devices also cite its predicate K934396.

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. 2022, 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 1.5T T/R Quad Extremity Coil is intended to be used in conjunction with a SIGNA Prime Magnetic Resonance Scanner to produce diagnostic images of the lower extremities that can be interpreted by a trained physician.

The 1.5T 8CH T/R Knee Coil is intended to be used in conjunction with a SIGNA Prime Magnetic Resonance Scanner to produce diagnostic images of the knee that can be interpreted by a trained physician.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K222257 · printed Nov 5, 2026

Cite this page

510(k) Report. “K222257: 1.5 T/R Quad Extremity Coil, 1.5T 8CH T/R Knee Coil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K222257

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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