510(k) · Cleared

Cleared

Alpha 7000 Quadrature Wrist Coil

K972205510(k) TraditionalCleared Sep 5, 199785-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

Usa Instruments, Inc. · MOS Coil, Magnetic Resonance, Specialty

Cleared on Sep 5, 1997 as substantially equivalent to K931008 (Mri Devices Corp., 1993) and 2 other predicates after an 85-day review. Its family tree reaches back 1 generation to 1993. 28 later devices descend from it.

Decided: Sep 5, 1997
Review: 85 days
Class: Class II
Product code: MOS
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K931008 (1993). 3 ancestors in all. 28 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 1 generation backK931008 Model #QWH-63, Quadrature Wrist and Hand CoilMri Devices Corp. · 1993
This deviceK972205 Alpha 7000 Quadrature Wrist CoilUsa Instruments, Inc. · 1997
Descendant · cites it directly · 22 of its ownK023982 Leo Iii TX/RX Quadrature Knee Coil; Alpha Iii TX/RX Quadrature Wrist…Usa Instruments, Inc. · 2003
Descendant · 2 generations on · 21 of its ownK082636 TXRX 15CH Knee Coil (1.5T and 3T), TXRX CP Extremity Coil 3TQuality Electrodynamics · 2008 · Recalled
Descendant · 3 generations on · 12 of its ownK100141 14-Channel Extremity Coil for Magnetom EssenzaSiemens Medical Solutions USA, Inc. · 2010
Descendant · 4 generations on · 11 of its ownK130262 Magnetom Essenza with Syngo MR D14Siemens Medical Solutions USA, Inc. · 2013
Descendant · 5 generations on · 9 of its ownK152283 MAGNETOM AmiraSiemens Medical Solutions USA, Inc. · 2015

Showing 5 of 28 descendants. See all descendants

Descendants cleared per year

2002high 6 (2016) · low 0 (2004)2026

Most influential descendants

Showing 5 of 28 · See all

K023982Leo Iii TX/RX Quadrature Knee Coil; Alpha Iii TX/RX Quadrature Wrist CoilUsa Instruments, Inc. · 2003 · cites it directly22descendants
K082636TXRX 15CH Knee Coil (1.5T and 3T), TXRX CP Extremity Coil 3TQuality Electrodynamics · 2008 · 2 generations on21descendants
K10014114-Channel Extremity Coil for Magnetom EssenzaSiemens Medical Solutions USA, Inc. · 2010 · 3 generations on12descendants
K130262Magnetom Essenza with Syngo MR D14Siemens Medical Solutions USA, Inc. · 2013 · 4 generations on11descendants
K152283MAGNETOM AmiraSiemens Medical Solutions USA, Inc. · 2015 · 5 generations on9descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K931008	Model #QWH-63, Quadrature Wrist and Hand Coil	Mri Devices Corp.	1993	—
0 (this device)	K972205	Alpha 7000 Quadrature Wrist Coil	Usa Instruments, Inc.	1997	—
+1	K023982	Leo Iii TX/RX Quadrature Knee Coil; Alpha Iii TX/RX Quadrature Wrist Coil	Usa Instruments, Inc.	2003	—
+2	K082636	TXRX 15CH Knee Coil (1.5T and 3T), TXRX CP Extremity Coil 3T	Quality Electrodynamics	2008	8
+3	K100141	14-Channel Extremity Coil for Magnetom Essenza	Siemens Medical Solutions USA, Inc.	2010	—
+4	K130262	Magnetom Essenza with Syngo MR D14	Siemens Medical Solutions USA, Inc.	2013	—
+5	K152283	MAGNETOM Amira	Siemens Medical Solutions USA, Inc.	2015	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1995	1	0
1997	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2003	2	0
2007	1	0
2008	2	0
2010	1	0
2012	1	0
2013	1	0
2015	3	0
2016	6	0
2017	2	0
2018	1	0
2019	1	0
2021	1	0
2022	1	0
2023	2	0
2025	1	0
2026	1	0

FIG. 1 — Lineage of K972205, 1993–2026Source: 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

Get a 510(k) Report

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
*	K931008	Model #QWH-63, Quadrature Wrist and Hand Coil Summary page 2 …Features of Alpha7000 Same as Predicate Device Quadrature Wrist Coil Intended Use Wrist and Hand Imaging Quadrature Wrist and Hand Coil Applications MRI Devices Corp. (K931008) Indications for Use , Identical to routine MRI imaging Quadrature Wrist and Hand Coil MRI Devices Corp. (K931008) Profile 70…	Mri Devices Corp.	1993	—
*	K964531	Profile 70000 Quadrature Volume Neck Coil Summary page 2 …for Use , Identical to routine MRI imaging Quadrature Wrist and Hand Coil MRI Devices Corp. (K931008) Profile 7000 Quadrature Volume Neck Coil USA Instruments, Inc. (K964531) Coil Body Material Flame retardant Polyurethane Lower Extremity Coil, Head Coil, and Vascular Head and Neck Coil, OUTLOOK MRI…	Us Asia Instruments, Inc.	1997	—
*	K945827	Outlook Summary page 2 …531) Coil Body Material Flame retardant Polyurethane Lower Extremity Coil, Head Coil, and Vascular Head and Neck Coil, OUTLOOK MRI System Picker International, Inc. (K945827) Coil Design Quadrature design Profile 7000 Quadrature Volume Neck Coil USA Instruments, Inc. (K964531) Decoupling RF Chokes with…	Philips Medical Systems (Cleveland), Inc.	1995	—

Also cleared against K931008: 1 other device →

What descends from it? (28)

See all 28

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

Number	Device	Applicant	Decided	Descendants
K023982	Leo Iii TX/RX Quadrature Knee Coil; Alpha Iii TX/RX Quadrature Wrist Coil	Usa Instruments, Inc.	2003	22
K031143	Alpha 5000 Wrist Coil	Usa Instruments, Inc.	2003	3
K072935	Speeder 1.5T Wrist Array Coil	Quality Electrodynamics	2007	2
K020268	Isaac 1.5 T MR System	Chi, Inc.	2002	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?

None of the 3 ancestors has a recall.
Of its descendants, K023982 (Usa Instruments, Inc., 2003) has gone furthest, with 22 descendants of its own.
1 other device also cites its predicate K931008.

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 Alpha 7000 Quadrature Wrist Coil is designed to provide Magnetic Resonance Images of the wrist and hand anatomy. The Alpha 7000 Quadrature Wrist Coil is designed for use with the GE Signa (1.5 Tesla) MRI Scanner. Anatomic Regions: Wrist and hand anatomy Nuclei Excited: Hydrogen The indications for use are the same as for standard imaging: The GE Signa system is indicated for use as an NMR device that produces images that: (1) correspond to the…

Read the full statement (132 words)

Anatomic Regions: Wrist and hand anatomy

Nuclei Excited: Hydrogen

The indications for use are the same as for standard imaging:

The GE Signa system is indicated for use as an NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR signal, (2) depend upon NMR parameters (proton density, 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.

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/K972205 · printed Nov 4, 2026

Cite this page

510(k) Report. “K972205: Alpha 7000 Quadrature Wrist Coil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K972205

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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