510(k) · Cleared
ClearedModel 580GE-64 Quadrature Abdominal Flex Coil
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Advances, Inc. · MOS Coil, Magnetic Resonance, Specialty
Cleared on Nov 20, 1995 after a 75-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 11 later devices descend from it.
- Decided
- Nov 20, 1995
- Review
- 75 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 0
11 later devices descend from it, 2 citing it directly.
- This deviceK954190 Model 580GE-64 Quadrature Abdominal Flex CoilMedical Advances, Inc. · 1995
- Descendant · cites it directly · 7 of its ownK093842 1.5T and 3.0T General Purpose Flex CoilsInvivo Corporation · 2010
- Descendant · 2 generations on · 5 of its ownK111673 1.5T and 3T 8-Channel Medium General Purpose Flex CoilInvivo Corporation · 2011
- Descendant · 2 generations on · 3 of its ownK122897 Sense Head 16 Model 800647, Sense Spine 16 Model 800646; Sense Torso…Invivo Corporation · 2012
- Descendant · 3 generations on · 3 of its ownK120122 Sense MSK S 8CH 1.5TInvivo Corporation · 2012
- Descendant · 3 generations on · 2 of its ownK212864 dS TorsoCardiac 1.5T, dS MSK S 1.5T, dS MSK M 1.5TPhilips Healthcare (Suzhou) Co., Ltd. · 2021
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K0938421.5T and 3.0T General Purpose Flex CoilsInvivo Corporation · 2010 · cites it directly7descendants
- K1116731.5T and 3T 8-Channel Medium General Purpose Flex CoilInvivo Corporation · 2011 · 2 generations on5descendants
- K122897Sense Head 16 Model 800647, Sense Spine 16 Model 800646; Sense Torso 16 Model 800645Invivo Corporation · 2012 · 2 generations on3descendants
- K120122Sense MSK S 8CH 1.5TInvivo Corporation · 2012 · 3 generations on3descendants
- K212864dS TorsoCardiac 1.5T, dS MSK S 1.5T, dS MSK M 1.5TPhilips Healthcare (Suzhou) Co., Ltd. · 2021 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K954190 | Model 580GE-64 Quadrature Abdominal Flex Coil | Medical Advances, Inc. | 1995 | — |
| +1 | K093842 | 1.5T and 3.0T General Purpose Flex Coils | Invivo Corporation | 2010 | — |
| +2 | K111673 | 1.5T and 3T 8-Channel Medium General Purpose Flex Coil | Invivo Corporation | 2011 | — |
| +2 | K122897 | Sense Head 16 Model 800647, Sense Spine 16 Model 800646; Sense Torso 16 Model… | Invivo Corporation | 2012 | — |
| +3 | K120122 | Sense MSK S 8CH 1.5T | Invivo Corporation | 2012 | — |
| +3 | K212864 | dS TorsoCardiac 1.5T, dS MSK S 1.5T, dS MSK M 1.5T | Philips Healthcare (Suzhou) Co., Ltd. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2003 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (11)
See all 112 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, K093842 (Invivo Corporation, 2010) has gone furthest, with 7 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 | — |
https://510kreport.com/device/K954190 · printed Nov 4, 2026
Cite this page
510(k) Report. “K954190: Model 580GE-64 Quadrature Abdominal Flex Coil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K954190
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026