510(k) · Cleared
ClearedModels Fac-63 and Fac-127 Foot and Ankle Coils
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mri Devices Corporation · MOS Coil, Magnetic Resonance, Specialty
Cleared on Mar 25, 2005 after a 24-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 8 later devices descend from it.
- Decided
- Mar 25, 2005
- Review
- 24 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 4 citing it directly.
- This deviceK050514 Models Fac-63 and Fac-127 Foot and Ankle CoilsMri Devices Corporation · 2005
- Descendant · cites it directly · 2 of its ownK162177 dS FootAnkle I6CH 1.5T CoilInvivo Corporation · 2016
- Descendant · 2 generations on · 1 of its ownK213766 dS FootAnkle 16Ch Coils for 1.5T and 3.0T, dS HiRes HandWrist 16Ch…Invivo Corporation · 2021
- Descendant · cites it directly · 1 of its ownK151653 8ch Foot Ankle CoilShenzhen RF Tech Co., Ltd. · 2015
- Descendant · cites it directly · 1 of its ownK122694 GE 8CH Foot Ankle CoilGe Hangwei Medical Systems Co., Ltd. · 2012
- Descendant · 3 generations on · 0 of its ownK262294 dS FootAnkle 16Ch 1.5T;dS FootAnkle 16Ch 3.0T;dS HiRes Hand/Wrist…Philips Medical Systems Nederland B.V. · 2026
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K162177dS FootAnkle I6CH 1.5T CoilInvivo Corporation · 2016 · cites it directly2descendants
- K213766dS FootAnkle 16Ch Coils for 1.5T and 3.0T, dS HiRes HandWrist 16Ch Coils for 1.5T and…Invivo Corporation · 2021 · 2 generations on1descendant
- K1516538ch Foot Ankle CoilShenzhen RF Tech Co., Ltd. · 2015 · cites it directly1descendant
- K122694GE 8CH Foot Ankle CoilGe Hangwei Medical Systems Co., Ltd. · 2012 · cites it directly1descendant
- K262294dS FootAnkle 16Ch 1.5T;dS FootAnkle 16Ch 3.0T;dS HiRes Hand/Wrist 16Ch 1.5T;dS HiRes…Philips Medical Systems Nederland B.V. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K050514 | Models Fac-63 and Fac-127 Foot and Ankle Coils | Mri Devices Corporation | 2005 | — |
| +1 | K162177 | dS FootAnkle I6CH 1.5T Coil | Invivo Corporation | 2016 | — |
| +2 | K213766 | dS FootAnkle 16Ch Coils for 1.5T and 3.0T, dS HiRes HandWrist 16Ch Coils for… | Invivo Corporation | 2021 | — |
| +1 | K151653 | 8ch Foot Ankle Coil | Shenzhen RF Tech Co., Ltd. | 2015 | — |
| +1 | K122694 | GE 8CH Foot Ankle Coil | Ge Hangwei Medical Systems Co., Ltd. | 2012 | — |
| +3 | K262294 | dS FootAnkle 16Ch 1.5T;dS FootAnkle 16Ch 3.0T;dS HiRes Hand/Wrist 16Ch 1.5T;dS… | Philips Medical Systems Nederland B.V. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2021 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (8)
4 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K162177 (Invivo Corporation, 2016) has gone furthest, with 2 descendants 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.
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?
To be used in conjunction with a Magnetic Resonance Scanner to produce
diagnostic images of the foot and ankle that can be interpreted by a trained
physician.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K050514 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050514: Models Fac-63 and Fac-127 Foot and Ankle Coils.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050514
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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