510(k) · Cleared
Cleared1.5T 16ch Shoulder Coil, 3.0T 16ch Shoulder Coil
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neocoil, LLC · MOS Coil, Magnetic Resonance, Specialty
Cleared on Jun 2, 2020 as substantially equivalent to K071611 (Neocoil, 2007) after a 39-day review. Its family tree reaches back 3 generations to 1995.
- Decided
- Jun 2, 2020
- Review
- 39 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K945778 (1995). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK945778 Phased Array Shoulder Coil, Quadrature Shoulder CoilMedical Advances, Inc. · 1995
- 2 generations backK042009 Mark Iii Phased Array Shoulder CoilUsa Instruments, Inc. · 2004
- 1 generation backK071611 Neocoil 3.0T 8-Channel Shoulder Array CoilNeocoil · 2007
- This deviceK201101 1.5T 16ch Shoulder Coil, 3.0T 16ch Shoulder CoilNeocoil, LLC · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K945778 | Phased Array Shoulder Coil, Quadrature Shoulder Coil | Medical Advances, Inc. | 1995 | — |
| −2 | K042009 | Mark Iii Phased Array Shoulder Coil | Usa Instruments, Inc. | 2004 | — |
| −1 | K071611 | Neocoil 3.0T 8-Channel Shoulder Array Coil | Neocoil | 2007 | — |
| 0 (this device) | 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 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 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 |
|---|---|---|---|
| * | K071611 | Neocoil 3.0T 8-Channel Shoulder Array CoilSummary page 5…0, Magnetic resonance diagnostic device, Product Code MOS 5.5. Predicate Device NeoCoil 3.0T 8-Channel Shoulder Array Coil, K071611 cleared on 06/28/2007. 5.6. Device Description The 1.5T 16ch Shoulder Coil and 3.0T 16ch Shoulder Coil are receive-only pha… | 2007 |
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 25 years and passes through 4 companies; a new generation was cleared every 9.4 years on median.
- 1 of the 7 ancestors has a recall of any class.
How does its category compare?
All MOS devicesMOS Coil, Magnetic Resonance, Specialty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
To be used in conjunction with GEHC 1.5T Magnetic Resonance Scanners to produce diagnostic images of the shoulder that can be interpreted by a trained physician.
To be used in conjunction with GEHC 3.0T Magnetic Resonance Scanners to produce diagnostic images of the shoulder that can be interpreted by a trained physician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201101 · printed Nov 4, 2026
Cite this page
510(k) Report. “K201101: 1.5T 16ch Shoulder Coil, 3.0T 16ch Shoulder Coil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K201101
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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