510(k) · Cleared
Recalled · 20081.5T Atlas Speeder Head-Neck Coil
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quality Electrodynamics · MOS Coil, Magnetic Resonance, Specialty
Cleared on Nov 7, 2008 as substantially equivalent to K041487 (Usa Instruments, Inc., 2004) after an 11-day review. Its family tree reaches back 3 generations to 1997. 4 later devices descend from it. It has been recalled once.
- Decided
- Nov 7, 2008
- Review
- 11 days
- Class
- Class II
- Product code
- MOS
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K964531 (1997). 4 ancestors in all. 4 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK964531 Profile 70000 Quadrature Volume Neck CoilUs Asia Instruments, Inc. · 1997
- 2 generations backK022582 Excalibur 9000 Totalsense Quad Head Array CoilUsa Instruments, Inc. · 2002
- 1 generation backK041487 QD Head Speeder with Speeder NV AttachmentUsa Instruments, Inc. · 2004
- This deviceK083160 1.5T Atlas Speeder Head-Neck CoilQuality Electrodynamics · 2008
- Descendant · cites it directly · 1 of its ownK142802 Atlas SPEEDER Head/NeckQuality Electrodynamics, LLC · 2014
- Descendant · 2 generations on · 0 of its ownK151829 Atlas SPEEDER Header/NeckQuality Electrodynamics, LLC · 2015
- Descendant · cites it directly · 0 of its ownK122638 Toshiba 3T 32CH Head Speeder Coil,Quality Electrodynamics · 2012
- Descendant · cites it directly · 0 of its ownK093667 Shoulder Speeder CoilQuality Electrodynamics · 2010
Most influential descendants
Showing 4 of 4 · See all- K142802Atlas SPEEDER Head/NeckQuality Electrodynamics, LLC · 2014 · cites it directly1descendant
- K151829Atlas SPEEDER Header/NeckQuality Electrodynamics, LLC · 2015 · 2 generations on0descendants
- K122638Toshiba 3T 32CH Head Speeder Coil,Quality Electrodynamics · 2012 · cites it directly0descendants
- K093667Shoulder Speeder CoilQuality Electrodynamics · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K964531 | Profile 70000 Quadrature Volume Neck Coil | Us Asia Instruments, Inc. | 1997 | — |
| −2 | K022582 | Excalibur 9000 Totalsense Quad Head Array Coil | Usa Instruments, Inc. | 2002 | — |
| −1 | K041487 | QD Head Speeder with Speeder NV Attachment | Usa Instruments, Inc. | 2004 | — |
| 0 (this device) | K083160 | 1.5T Atlas Speeder Head-Neck Coil | Quality Electrodynamics | 2008 | — |
| +1 | K142802 | Atlas SPEEDER Head/Neck | Quality Electrodynamics, LLC | 2014 | — |
| +2 | K151829 | Atlas SPEEDER Header/Neck | Quality Electrodynamics, LLC | 2015 | — |
| +1 | K122638 | Toshiba 3T 32CH Head Speeder Coil, | Quality Electrodynamics | 2012 | — |
| +1 | 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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K041487 | QD Head Speeder with Speeder NV AttachmentSummary page 1…n name Coil, magnetic resonance, specialty 6. Classification 21 CFR 892.1000 7. Equivalent Device 1.5T QD Head Speeder Coil manufactured by USA Instruments Inc. (K041487). 8. Device Description The Atlas SPEEDER Head-Neck coil is a phased array, multi-channel, receive-only coil. The coil consis… | 2004 |
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 29, 2008 | Not classified | Z-1938-2009 | Device Design | The firm received a complaint indicating that the mirror is high risk and could drop on a patient. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 4.4 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K142802 (Quality Electrodynamics, LLC, 2014) has gone furthest, with 1 descendant of its own.
How does its category compare?
All MOS devicesMOS Coil, Magnetic Resonance, Specialty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
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?
For use with a Toshiba Excelart Vantage Atlas or Vantage Titan MR scanner to produce diagnostic images of the brain, cervical spine, and soft tissue and vasculature of the head, neck and upper chest that can be interpreted by a trained physician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083160 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083160: 1.5T Atlas Speeder Head-Neck Coil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083160
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