510(k) · Cleared
ClearedAlpha 5000 Wrist Coil
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Usa Instruments, Inc. · MOS Coil, Magnetic Resonance, Specialty
Cleared on May 29, 2003 as substantially equivalent to K972205 (Usa Instruments, Inc., 1997) after a 49-day review. Its family tree reaches back 2 generations to 1993. 3 later devices descend from it.
- Decided
- May 29, 2003
- Review
- 49 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K931008 (1993). 4 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK931008 Model #QWH-63, Quadrature Wrist and Hand CoilMri Devices Corp. · 1993
- 1 generation backK972205 Alpha 7000 Quadrature Wrist CoilUsa Instruments, Inc. · 1997
- This deviceK031143 Alpha 5000 Wrist CoilUsa Instruments, Inc. · 2003
- Descendant · cites it directly · 2 of its ownK072935 Speeder 1.5T Wrist Array CoilQuality Electrodynamics · 2007
- Descendant · 2 generations on · 1 of its ownK083014 Atlas Speeder Head/Cervical Coil, Model Mjah-137AToshiba America Medical Systems, In.C · 2008
- Descendant · 3 generations on · 0 of its ownK121910 Octave Speeder HeadToshiba Medical Systems Corporation, Japan · 2012
Most influential descendants
Showing 3 of 3 · See all- K072935Speeder 1.5T Wrist Array CoilQuality Electrodynamics · 2007 · cites it directly2descendants
- K083014Atlas Speeder Head/Cervical Coil, Model Mjah-137AToshiba America Medical Systems, In.C · 2008 · 2 generations on1descendant
- K121910Octave Speeder HeadToshiba Medical Systems Corporation, Japan · 2012 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K931008 | Model #QWH-63, Quadrature Wrist and Hand Coil | Mri Devices Corp. | 1993 | — |
| −1 | K972205 | Alpha 7000 Quadrature Wrist Coil | Usa Instruments, Inc. | 1997 | — |
| 0 (this device) | K031143 | Alpha 5000 Wrist Coil | Usa Instruments, Inc. | 2003 | — |
| +1 | K072935 | Speeder 1.5T Wrist Array Coil | Quality Electrodynamics | 2007 | — |
| +2 | K083014 | Atlas Speeder Head/Cervical Coil, Model Mjah-137A | Toshiba America Medical Systems, In.C | 2008 | — |
| +3 | K121910 | Octave Speeder Head | Toshiba Medical Systems Corporation, Japan | 2012 | — |
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 |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2012 | 1 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K972205 | Alpha 7000 Quadrature Wrist CoilSummary page 2…roducts intended Use: Imaging of the wrist and -Similar to the Alpha 7000 Wrist Coil manufactured hand. by USA Instruments, Inc. (K972205) Indications for Use: Identical to routine -Similar to the Alpha 7000 Wrist Coil manufactured MRI imaging.… | 1997 |
| † | K001210 | HI-Res 9000 Phased Array Carotid Coil | 2000 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K072935 | Speeder 1.5T Wrist Array Coil | 2007 | 2 |
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 10 years and passes through 2 companies; a new generation was cleared every 5.7 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K072935 (Quality Electrodynamics, 2007) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K972205.
How does its category compare?
All MOS devicesMOS Coil, Magnetic Resonance, Specialty: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MOS
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MOS
59in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MOS
13in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MOS
2in 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 5000 Wrist Coil is designed to provide Magnetic Resonance Images of the hand and wrist. The Alpha 5000 Wrist Coil is designed for use with the Toshiba OPART 0.35T MR scanner manufactured by Toshiba Medical Systesm, Inc. Anatomic Regions: Wrist and hand Nuclei Excited: Hydrogen The indications for use are the same as for standard imaging: The 0.35T MRI system is indicated for use as an NMR device that produces images that: (1) correspond to the…
Read the full statement (133 words)
The Alpha 5000 Wrist Coil is designed to provide Magnetic Resonance Images of the hand and wrist. The Alpha 5000 Wrist Coil is designed for use with the Toshiba OPART 0.35T MR scanner manufactured by Toshiba Medical Systesm, Inc.
Anatomic Regions: Wrist and hand
Nuclei Excited: Hydrogen
The indications for use are the same as for standard imaging:
The 0.35T MRI 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 as stated in the FDA summary.
https://510kreport.com/device/K031143 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031143: Alpha 5000 Wrist Coil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031143
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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