510(k) · Cleared
Cleared4CH Flex Speeder
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Toshiba Medical Systems Coporation, Japan · MOS Coil, Magnetic Resonance, Specialty
Cleared on Sep 15, 2011 as substantially equivalent to K111251 (Toshiba Medical Systems Coporation, Japan, 2011) after a 29-day review. Its family tree reaches back 6 generations to 2000.
- Decided
- Sep 15, 2011
- Review
- 29 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K002531 (2000). No later device cites it as a predicate yet.
- Root · 6 generations backK002531 Excelart with Pianissimo, Model MRT-1501/P3Toshiba America Mri, Inc. · 2000 · Recalled
- 5 generations backK023511 Excelart with Pianissimo XG/AG Spin Edition, Model MRT-1501/P3, P2Toshiba America Medical Systems, In.C · 2002 · Recalled
- 4 generations backK032490 Toshiba Excelart Vantage XGV/Agv Mri Diagnostic System, Models…Toshiba America Medical Systems, In.C · 2003 · Recalled
- 3 generations backK060003 Excelart Vantage ZGVToshibamedical Systems Corporation · 2006 · Recalled
- 2 generations backK063361 Excelart Vantage Atlas, Model MRT-1503Toshiba America Medical Systems, In.C · 2006 · Recalled
- 1 generation backK111251 4CH Flex SpeederToshiba Medical Systems Coporation, Japan · 2011
- This deviceK112366 4CH Flex SpeederToshiba Medical Systems Coporation, Japan · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K002531 | Excelart with Pianissimo, Model MRT-1501/P3 | Toshiba America Mri, Inc. | 2000 | 4 |
| −5 | K023511 | Excelart with Pianissimo XG/AG Spin Edition, Model MRT-1501/P3, P2 | Toshiba America Medical Systems, In.C | 2002 | 2 |
| −4 | K032490 | Toshiba Excelart Vantage XGV/Agv Mri Diagnostic System, Models MRT-1503/P3 and… | Toshiba America Medical Systems, In.C | 2003 | 3 |
| −3 | K060003 | Excelart Vantage ZGV | Toshibamedical Systems Corporation | 2006 | 1 |
| −2 | K063361 | Excelart Vantage Atlas, Model MRT-1503 | Toshiba America Medical Systems, In.C | 2006 | 1 |
| −1 | K111251 | 4CH Flex Speeder | Toshiba Medical Systems Coporation, Japan | 2011 | — |
| 0 (this device) | K112366 | 4CH Flex Speeder | Toshiba Medical Systems Coporation, Japan | 2011 | — |
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 |
|---|---|---|---|
| * | K111251 | 4CH Flex SpeederSummary page 2…orporation believes that this 4ch Flex SPEEDER (Model Number MJAJ-192A is substantially equivalent to the current 4ch Flex SPEEDER (Model number MJAJ-197A, K111251). 11. Software There is no software required for this coil. A-2 ===… | 2011 |
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 11 years and passes through 4 companies; a new generation was cleared every 2.0 years on median.
- 5 of the 6 ancestors have a recall of any class.
How does its category compare?
All MOS devicesMOS Coil, Magnetic Resonance, Specialty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
Imaging of the extremities (Foot and Hand), joints (knee, shoulder, ankle, wrist and elbow), and body (chest, abdomen and pelvis).
MJAJ-192A is intended to be used on the Toshiba Vantage Titan 3T MR System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112366 · printed Nov 3, 2026
Cite this page
510(k) Report. “K112366: 4CH Flex Speeder.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K112366
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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