510(k) · Cleared
ClearedBreast Speeder CX, Grid Holder CX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quality Electrodynamics, LLC · MOS Coil, Magnetic Resonance, Specialty
Cleared on Aug 22, 2014 as substantially equivalent to K060873 (Sentinelle Medical, Inc., 2006) after a 30-day review. Its family tree reaches back 2 generations to 1999.
- Decided
- Aug 22, 2014
- Review
- 30 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K993776 (1999). 4 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K993776 | Obc-300 Breast Array Coil | Mri Devices Corp. | 1999 | — |
| −1 | K060873 | Vanguard Mri Auxiliary Patient Table with 4 and 8 Channel Coil Array for GE… | Sentinelle Medical, Inc. | 2006 | — |
| 0 (this device) | K142002 | Breast Speeder CX, Grid Holder CX | Quality Electrodynamics, LLC | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2004 | 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 |
|---|---|---|---|
| * | K060873 | Vanguard Mri Auxiliary Patient Table with 4 and 8 Channel Coil Array for GE Signa SystemsSummary page 5…1000, Product Code MOS, Class II) 7. Predicate Device Vanguard Breast MRI Auxiliary Table with 8 Channel Coil Array, Sentinelle Medical, Inc., K060873 No reference devices were used in this submission. 8. Device Description The Breast SPEEDER CX is a receive-… | 2006 |
| † | K122638 | Toshiba 3T 32CH Head Speeder Coil, | 2012 |
| † | K140998 | Pediatric 16, A1.5T Tim Coil/Pediatric 16, A3T Tim Coil | 2014 |
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 8.4 years on median.
- 1 of the 4 ancestors has a recall of any class.
- 2 other devices also cite its predicate K060873.
How does its category compare?
All MOS devicesMOS Coil, Magnetic Resonance, Specialty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 Breast SPEEDER CX is intended for use with Toshiba 1.5T MRI systems to produce diagnostic images of the breast anatomy that can be interpreted by a trained physician.
The Grid Holder CX kit is intended for use with the Breast SPEEDER CX to permit access to the breast anatomy for biopsy and lesion localization procedures.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K142002 · printed Nov 3, 2026
Cite this page
510(k) Report. “K142002: Breast Speeder CX, Grid Holder CX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K142002
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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