510(k) · Cleared

Cleared

Maxim 7000 Quadrature Extremity Coil Model Number Qec-Gem-15A

K964820510(k) TraditionalCleared Feb 28, 199788-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

Us Asia Instruments, Inc. · MOS Coil, Magnetic Resonance, Specialty

Cleared on Feb 28, 1997 as substantially equivalent to K944469 (Philips Medical Systems (Cleveland), Inc., 1995) and 2 other predicates after an 88-day review. Its family tree reaches back 2 generations to 1989.

Decided: Feb 28, 1997
Review: 88 days
Class: Class II
Product code: MOS
Recalls: None
Predicates: 3

Its longest line of descent runs back 2 generations to K893619 (1989). 5 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK893619 Vista MR 2055 HP SystemPhilips Medical Systems (Cleveland), Inc. · 1989
1 generation backK960497 Flexible Phased Array Spine CoilPhilips Medical Systems (Cleveland), Inc. · 1996
This deviceK964820 Maxim 7000 Quadrature Extremity Coil Model Number Qec-Gem-15AUs Asia Instruments, Inc. · 1997

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K893619	Vista MR 2055 HP System	Philips Medical Systems (Cleveland), Inc.	1989	—
−1	K960497	Flexible Phased Array Spine Coil	Philips Medical Systems (Cleveland), Inc.	1996	—
0 (this device)	K964820	Maxim 7000 Quadrature Extremity Coil Model Number Qec-Gem-15A	Us Asia Instruments, Inc.	1997	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1995	3	0

FIG. 1 — Lineage of K964820, 1989–1997Source: 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? (3)

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
*	K944469	General Purpose Flex Coil Summary page 2 …ase turn over 9. Safety and Effectiveness Parameter Quadrature Elbow Predicate Coil Intended Use Elbow Imaging Applications \| General Purpose Flex Coil (K944469) marketed by Picker International Indications for Use Identical to routine MRI General Purpose Flex Coil imaging (K944469) market…	Philips Medical Systems (Cleveland), Inc.	1995	—
*	K960497	Flexible Phased Array Spine Coil Summary page 2 …for Use Identical to routine MRI General Purpose Flex Coil imaging (K944469) marketed by Picker International Coil Enclosure Material Vinyl Fabric Flexible Spine Coil . (K960497) marketed by Picker International Coil Design Quadrature design Profile 7000 C-spine Coil (K943440) marketed by US Asia Instrumen…	Philips Medical Systems (Cleveland), Inc.	1996	—
*	K943440	Profile 7000 C-Spine Coil Summary page 2 …ernational Coil Enclosure Material Vinyl Fabric Flexible Spine Coil . (K960497) marketed by Picker International Coil Design Quadrature design Profile 7000 C-spine Coil (K943440) marketed by US Asia Instruments. Inc. Decoupling Switching Diode decoupling \| Profile 7000 C-spine Coil (K943440) marketed by US…	Us Asia Instruments, Inc.	1995	—

Also cleared against K944469: 1 other device →

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 7.0 years on median.
None of the 5 ancestors has a recall.
1 other device also cites its predicate K944469.

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 Quadrature Extremity Coil is a receive-only quadrature RF coil, used for obtaining diagnostic images of the elbow anatomy in Magnetic Resonance Imaging systems. The indications for use are the same as for standard MR Imaging.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K964820 · printed Nov 4, 2026

Cite this page

510(k) Report. “K964820: Maxim 7000 Quadrature Extremity Coil Model Number Qec-Gem-15A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K964820

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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