510(k) · Cleared
ClearedModel 545G-64 Pahased Array Musculoskeletal Flex Coil Package Model 543GE-64: Phased Array Upper Extrenity Flex Coil Any
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 Oct 6, 1998 after a 32-day review. The FDA summary names no predicate by number. 4 later devices descend from it.
- Decided
- Oct 6, 1998
- Review
- 32 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK983109 Model 545G-64 Pahased Array Musculoskeletal Flex Coil Package Model…Medical Advances, Inc. · 1998
- Descendant · cites it directly · 3 of its ownK091902 1.5T 8-Channel Small Extremity Coil, Model 800494, 3.0T 8-Channel…Invivo · 2009
- Descendant · 2 generations on · 2 of its ownK162863 dS Small Extremity 16CH 1.5T CoilInvivo Therapeutics Corporation · 2016
- Descendant · 3 generations on · 1 of its ownK213766 dS FootAnkle 16Ch Coils for 1.5T and 3.0T, dS HiRes HandWrist 16Ch…Invivo Corporation · 2021
- Descendant · 4 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
Most influential descendants
Showing 4 of 4 · See all- K0919021.5T 8-Channel Small Extremity Coil, Model 800494, 3.0T 8-Channel Small Extremity Coil…Invivo · 2009 · cites it directly3descendants
- K162863dS Small Extremity 16CH 1.5T CoilInvivo Therapeutics Corporation · 2016 · 2 generations on2descendants
- K213766dS FootAnkle 16Ch Coils for 1.5T and 3.0T, dS HiRes HandWrist 16Ch Coils for 1.5T and…Invivo Corporation · 2021 · 3 generations on1descendant
- 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 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K983109 | Model 545G-64 Pahased Array Musculoskeletal Flex Coil Package Model 543GE-64… | Medical Advances, Inc. | 1998 | — |
| +1 | K091902 | 1.5T 8-Channel Small Extremity Coil, Model 800494, 3.0T 8-Channel Small… | Invivo | 2009 | — |
| +2 | K162863 | dS Small Extremity 16CH 1.5T Coil | Invivo Therapeutics Corporation | 2016 | — |
| +3 | K213766 | dS FootAnkle 16Ch Coils for 1.5T and 3.0T, dS HiRes HandWrist 16Ch Coils for… | Invivo Corporation | 2021 | — |
| +4 | 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 |
|---|---|---|
| 2009 | 1 | 0 |
| 2016 | 1 | 0 |
| 2021 | 1 | 0 |
| 2026 | 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?
The FDA summary names no predicate by number.
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K091902 | 1.5T 8-Channel Small Extremity Coil, Model 800494, 3.0T 8-Channel Small Extremity Coil… | 2009 | 3 |
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, K091902 (Invivo, 2009) has gone furthest, with 3 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?
Magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA) of the bones,
soft tissue, musculoskeletal structures and vascular structures of the upper and lower
extremities.
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/K983109 · printed Nov 4, 2026
Cite this page
510(k) Report. “K983109: Model 545G-64 Pahased Array Musculoskeletal Flex Coil Package Model 543GE-64: Phased Array Upper Extrenity Flex Coil Any.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983109
Report an extraction error
Are you the manufacturer?
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