510(k) · Cleared
ClearedQD Head Speeder with Speeder NV Attachment
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 Jun 17, 2004 as substantially equivalent to K001870 (Usa Instruments, Inc., 2000) and 1 other predicate after a 13-day review. Its family tree reaches back 2 generations to 1997. 5 later devices descend from it.
- Decided
- Jun 17, 2004
- Review
- 13 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K964531 (1997). 3 ancestors in all. 5 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK964531 Profile 70000 Quadrature Volume Neck CoilUs Asia Instruments, Inc. · 1997
- 1 generation backK022582 Excalibur 9000 Totalsense Quad Head Array CoilUsa Instruments, Inc. · 2002
- This deviceK041487 QD Head Speeder with Speeder NV AttachmentUsa Instruments, Inc. · 2004
- Descendant · cites it directly · 4 of its ownK083160 1.5T Atlas Speeder Head-Neck CoilQuality Electrodynamics · 2008 · Recalled
- Descendant · 2 generations on · 1 of its ownK142802 Atlas SPEEDER Head/NeckQuality Electrodynamics, LLC · 2014
- Descendant · 3 generations on · 0 of its ownK151829 Atlas SPEEDER Header/NeckQuality Electrodynamics, LLC · 2015
- Descendant · 2 generations on · 0 of its ownK122638 Toshiba 3T 32CH Head Speeder Coil,Quality Electrodynamics · 2012
- Descendant · 2 generations on · 0 of its ownK093667 Shoulder Speeder CoilQuality Electrodynamics · 2010
Most influential descendants
Showing 5 of 5 · See all- K0831601.5T Atlas Speeder Head-Neck CoilQuality Electrodynamics · 2008 · cites it directly4descendants
- K142802Atlas SPEEDER Head/NeckQuality Electrodynamics, LLC · 2014 · 2 generations on1descendant
- K151829Atlas SPEEDER Header/NeckQuality Electrodynamics, LLC · 2015 · 3 generations on0descendants
- K122638Toshiba 3T 32CH Head Speeder Coil,Quality Electrodynamics · 2012 · 2 generations on0descendants
- K093667Shoulder Speeder CoilQuality Electrodynamics · 2010 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K964531 | Profile 70000 Quadrature Volume Neck Coil | Us Asia Instruments, Inc. | 1997 | — |
| −1 | K022582 | Excalibur 9000 Totalsense Quad Head Array Coil | Usa Instruments, Inc. | 2002 | — |
| 0 (this device) | K041487 | QD Head Speeder with Speeder NV Attachment | Usa Instruments, Inc. | 2004 | — |
| +1 | K083160 | 1.5T Atlas Speeder Head-Neck Coil | Quality Electrodynamics | 2008 | 1 |
| +2 | K142802 | Atlas SPEEDER Head/Neck | Quality Electrodynamics, LLC | 2014 | — |
| +3 | K151829 | Atlas SPEEDER Header/Neck | Quality Electrodynamics, LLC | 2015 | — |
| +2 | K122638 | Toshiba 3T 32CH Head Speeder Coil, | Quality Electrodynamics | 2012 | — |
| +2 | K093667 | Shoulder Speeder Coil | Quality Electrodynamics | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 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? (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 | Decided |
|---|---|---|---|
| * | K001870 | Millennium 9000 Phased Array Neurovascular CoilSummary page 2…sed Array MRI imaging. Neurovascular Coil manufactured by USA Instruments, Inc. (K001870) -Similar to the Excalibur 9000 TotalSENSE Tm Quad… | 2000 |
| * | K022582 | Excalibur 9000 Totalsense Quad Head Array CoilSummary page 2…alSENSETM Quad Array Head Coil manufactured by USA Instruments, Inc. (K022582) Indications for Use: Identical to routine -Similar to the Millennium 9000 Phased Array MRI imaging.… | 2002 |
| † | K024187 | Spirit Iii Totalsense Cardiac Coil | 2003 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K083160 | 1.5T Atlas Speeder Head-Neck Coil | 2008 | 4 |
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 7 years and passes through 2 companies; a new generation was cleared every 5.7 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K083160 (Quality Electrodynamics, 2008) has gone furthest, with 4 descendants of its own.
- 6 other devices also cite its predicate K001870.
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 QD Head Speeder with NV Speeder Attachment is designed to provide Magnetic Resonance Images of the brain, cervical spine, and soft tissue and vasculature of the head, neck, and upper chest. The OD Head Speeder with NV Speeder Attachment is designed for use with the ExcelArt 1.5 MRI system manufactured by Toshiba Medical Systems, Inc. Anatomic Regions: brain, cervical spine, and soft tissue and vasculature of the head, neck, and upper chest Nuclei…
Read the full statement (162 words)
The QD Head Speeder with NV Speeder Attachment is designed to provide Magnetic Resonance Images of the brain, cervical spine, and soft tissue and vasculature of the head, neck, and upper chest. The OD Head Speeder with NV Speeder Attachment is designed for use with the ExcelArt 1.5 MRI system manufactured by Toshiba Medical Systems, Inc.
Anatomic Regions: brain, cervical spine, and soft tissue and vasculature of the head, neck, and upper chest
Nuclei Excited: Hydrogen
The indications for use are the same as for standard imaging:
The 1.5T 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/K041487 · printed Nov 5, 2026
Cite this page
510(k) Report. “K041487: QD Head Speeder with Speeder NV Attachment.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041487
Report an extraction error
Are you the manufacturer?
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