510(k) · Cleared
ClearedToshiba 3T 32CH Head Speeder 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 Sep 25, 2012 as substantially equivalent to K083160 (Quality Electrodynamics, 2008) after a 27-day review. Its family tree reaches back 4 generations to 1997.
- Decided
- Sep 25, 2012
- Review
- 27 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K964531 (1997). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK964531 Profile 70000 Quadrature Volume Neck CoilUs Asia Instruments, Inc. · 1997
- 3 generations backK022582 Excalibur 9000 Totalsense Quad Head Array CoilUsa Instruments, Inc. · 2002
- 2 generations backK041487 QD Head Speeder with Speeder NV AttachmentUsa Instruments, Inc. · 2004
- 1 generation backK083160 1.5T Atlas Speeder Head-Neck CoilQuality Electrodynamics · 2008 · Recalled
- This deviceK122638 Toshiba 3T 32CH Head Speeder Coil,Quality Electrodynamics · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K964531 | Profile 70000 Quadrature Volume Neck Coil | Us Asia Instruments, Inc. | 1997 | — |
| −3 | K022582 | Excalibur 9000 Totalsense Quad Head Array Coil | Usa Instruments, Inc. | 2002 | — |
| −2 | 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 |
| 0 (this device) | K122638 | Toshiba 3T 32CH Head Speeder Coil, | Quality Electrodynamics | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 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 |
|---|---|---|---|
| * | K083160 | 1.5T Atlas Speeder Head-Neck CoilSummary page 2…94 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS 10. Comparison with Predicate Devices ____A- e c' - ~ K083 160 1.5T Atlas SPEED5ER Head-Neck Quality Electrodynamics Coil The Toshiba 3T 32CH Head SPEEDER Coil in t… | 2008 |
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 15 years and passes through 3 companies; a new generation was cleared every 4.4 years on median.
- 1 of the 5 ancestors has a recall of any class.
- 2 other devices also cite its predicate K083160.
How does its category compare?
All MOS devicesMOS Coil, Magnetic Resonance, Specialty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
The Toshiba 3T 32CH Head SPEEDER Coil is intended for use with the Toshiba Vantage Titan 3T MRI system to produce diagnostic images of the head that can be interpreted by a trained physician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122638 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122638: Toshiba 3T 32CH Head Speeder Coil,.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122638
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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