510(k) · Cleared
ClearedAtlas Speeder Head/Cervical Coil, Model Mjah-137A
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Toshiba America Medical Systems, In.C · MOS Coil, Magnetic Resonance, Specialty
Cleared on Oct 17, 2008 as substantially equivalent to K063361 (Toshiba America Medical Systems, In.C, 2006) and 1 other predicate after an 8-day review. Its family tree reaches back 5 generations to 2000. 1 later device descends from it.
- Decided
- Oct 17, 2008
- Review
- 8 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K002531 (2000). 12 ancestors in all, the oldest K931008 (1993). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK002531 Excelart with Pianissimo, Model MRT-1501/P3Toshiba America Mri, Inc. · 2000 · Recalled
- 4 generations backK023511 Excelart with Pianissimo XG/AG Spin Edition, Model MRT-1501/P3, P2Toshiba America Medical Systems, In.C · 2002 · Recalled
- 3 generations backK032490 Toshiba Excelart Vantage XGV/Agv Mri Diagnostic System, Models…Toshiba America Medical Systems, In.C · 2003 · Recalled
- 2 generations backK060003 Excelart Vantage ZGVToshibamedical Systems Corporation · 2006 · Recalled
- 1 generation backK063361 Excelart Vantage Atlas, Model MRT-1503Toshiba America Medical Systems, In.C · 2006 · Recalled
- This deviceK083014 Atlas Speeder Head/Cervical Coil, Model Mjah-137AToshiba America Medical Systems, In.C · 2008
- Descendant · cites it directly · 0 of its ownK121910 Octave Speeder HeadToshiba Medical Systems Corporation, Japan · 2012
Most influential descendants
Showing 1 of 1 · See all- K121910Octave Speeder HeadToshiba Medical Systems Corporation, Japan · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K002531 | Excelart with Pianissimo, Model MRT-1501/P3 | Toshiba America Mri, Inc. | 2000 | 4 |
| −4 | K023511 | Excelart with Pianissimo XG/AG Spin Edition, Model MRT-1501/P3, P2 | Toshiba America Medical Systems, In.C | 2002 | 2 |
| −3 | K032490 | Toshiba Excelart Vantage XGV/Agv Mri Diagnostic System, Models MRT-1503/P3 and… | Toshiba America Medical Systems, In.C | 2003 | 3 |
| −2 | K060003 | Excelart Vantage ZGV | Toshibamedical Systems Corporation | 2006 | 1 |
| −1 | K063361 | Excelart Vantage Atlas, Model MRT-1503 | Toshiba America Medical Systems, In.C | 2006 | 1 |
| 0 (this device) | K083014 | Atlas Speeder Head/Cervical Coil, Model Mjah-137A | Toshiba America Medical Systems, In.C | 2008 | — |
| +1 | K121910 | Octave Speeder Head | Toshiba Medical Systems Corporation, Japan | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 2 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K063361 | Excelart Vantage Atlas, Model MRT-1503Summary page 2…formation Toshiba Medical Systems Corporation believes that this Atlas SPEEDER Head/Cervical is substantially equivalent to the current Atlas SPEEDER Head (K063361] and SPEEDER 1.5T Wrist coil [K072935]. 11. Software There is no additional software required for this coil.… | 2006 |
| * | K072935 | Speeder 1.5T Wrist Array CoilSummary page 2…oration believes that this Atlas SPEEDER Head/Cervical is substantially equivalent to the current Atlas SPEEDER Head (K063361] and SPEEDER 1.5T Wrist coil [K072935]. 11. Software There is no additional software required for this coil.… | 2007 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K121910 | Octave Speeder Head | 2012 | 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?
- The line of descent spans 8 years and passes through 3 companies; a new generation was cleared every 1.9 years on median.
- 5 of the 12 ancestors have a recall of any class.
- Of its descendants, K121910 (Toshiba Medical Systems Corporation, Japan, 2012) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K063361.
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?
The MJAH-137A Atlas SPEEDER Head/Cervical Coil in intended for the use of diagnostic imaging of the human body, fluid visualization, 2D and 3D imaging, MR angiography and MR Fluoroscopy.
This coil is intended to be used on the Atlas Vantage, model numbers MRT-1503/S3,S5 and the Atlas Titan, model number MRT-1504.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083014 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083014: Atlas Speeder Head/Cervical Coil, Model Mjah-137A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083014
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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