510(k) · Cleared
ClearedMark Iii Phased Array Shoulder Coil
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Usa Instruments, Inc. · MOS Coil, Magnetic Resonance, Specialty
Cleared on Aug 11, 2004 as substantially equivalent to K010946 (Usa Instruments, Inc., 2001) and 1 other predicate after a 16-day review. Its family tree reaches back 1 generation to 1995. 2 later devices descend from it.
- Decided
- Aug 11, 2004
- Review
- 16 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K945778 (1995). 2 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK945778 Phased Array Shoulder Coil, Quadrature Shoulder CoilMedical Advances, Inc. · 1995
- This deviceK042009 Mark Iii Phased Array Shoulder CoilUsa Instruments, Inc. · 2004
- Descendant · cites it directly · 1 of its ownK071611 Neocoil 3.0T 8-Channel Shoulder Array CoilNeocoil · 2007
- Descendant · 2 generations on · 0 of its ownK201101 1.5T 16ch Shoulder Coil, 3.0T 16ch Shoulder CoilNeocoil, LLC · 2020
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K945778 | Phased Array Shoulder Coil, Quadrature Shoulder Coil | Medical Advances, Inc. | 1995 | — |
| 0 (this device) | K042009 | Mark Iii Phased Array Shoulder Coil | Usa Instruments, Inc. | 2004 | — |
| +1 | K071611 | Neocoil 3.0T 8-Channel Shoulder Array Coil | Neocoil | 2007 | — |
| +2 | K201101 | 1.5T 16ch Shoulder Coil, 3.0T 16ch Shoulder Coil | Neocoil, LLC | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2020 | 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? (2)
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 |
|---|---|---|---|
| * | K010946 | Mark 9000 Phased Array Shoulder CoilSummary page 2…manuatrdb Shoulder imaging applications USA Instruments Inc. (K010946) -Similar to the Phased Array Shoulder Coil manufactured… | 2001 |
| * | K945778 | Phased Array Shoulder Coil, Quadrature Shoulder CoilSummary page 2…-Similar to the Phased Array Shoulder Coil manufactured by Medical Advances Inc. (K945778) Indications for Use -Similar to the Mark 9000 Shoulder Coil manufactured by Identical to routi… | 1995 |
| † | K994345 | Magna 5000 Phased Array CTL Spine Coil | 2000 |
| † | K022582 | Excalibur 9000 Totalsense Quad Head Array Coil | 2002 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K071611 | Neocoil 3.0T 8-Channel Shoulder Array Coil | 2007 | 1 |
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?
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?
The Mark III Phased Array Shoulder Coil is a receive-only phased array RF coil, used for obtaining diagnostic images of the shoulder and adjacent regions in Magnetic Resonance Imaging systems. The indications for use are the same as for standard MR Imaging. The Mark III Phased Array Coil is designed for use with the Signa EXCITE 3.0T MRI scanner manufactured by GE Medical Systems, Inc
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042009 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042009: Mark Iii Phased Array Shoulder Coil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042009
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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