510(k) · Cleared
Recalled · Class III · 20201.5T and 3.0T 16 CH GE Shoulder Coils
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Invivo Corporation · MOS Coil, Magnetic Resonance, Specialty
Cleared on Aug 31, 2016 as substantially equivalent to K053017 (Invivo Corporation, 2005) after a 42-day review. Its family tree reaches back 1 generation to 2005. 2 later devices descend from it. It has been recalled once.
- Decided
- Aug 31, 2016
- Review
- 42 days
- Class
- Class II
- Product code
- MOS
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K053017 (2005). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK053017 Models HRS-63-8 and HRS-127-8 Shoulder Array CoilsInvivo Corporation · 2005 · Recalled
- This deviceK162001 1.5T and 3.0T 16 CH GE Shoulder CoilsInvivo Corporation · 2016
- Descendant · cites it directly · 1 of its ownK232021 Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5TPhilips Healthcare (Suzhou) Co., Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK260519 Smart Fit TorsoCardiac 1.5TPhilips Healthcare (Suzhou) Co., Ltd. · 2026
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 | K053017 | Models HRS-63-8 and HRS-127-8 Shoulder Array Coils | Invivo Corporation | 2005 | 1 |
| 0 (this device) | K162001 | 1.5T and 3.0T 16 CH GE Shoulder Coils | Invivo Corporation | 2016 | — |
| +1 | K232021 | Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T | Philips Healthcare (Suzhou) Co., Ltd. | 2023 | — |
| +2 | K260519 | Smart Fit TorsoCardiac 1.5T | Philips Healthcare (Suzhou) Co., Ltd. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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? (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 |
|---|---|---|---|
| * | K053017 | Models HRS-63-8 and HRS-127-8 Shoulder Array CoilsSummary page 8…Predicate 510(k) Submission Reference HRS-63-8 and HRS-127-8 Shoulder Array Coils K053017 SafetyandEffectiveness: The proposed 1.5T and 3.0T 16 Ch GE Shoulder Coils labeling contain instructions for use and necessa… | 2005 |
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 |
|---|---|---|---|
| K232021 | Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T | 2023 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 14, 2020 | Class III | Z-0126-2021 | Labeling Change Control | The labels have been mistakenly printed with an IPX1 rating symbol. IPX ratings relate to protections that products have from water ingress. |
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. 2016, 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?
The 16 Channel Shoulder Coil is to be used in conjunction with Magnetic Resonance Scanners to produce diagnostic
images of the shoulder that can be interpreted by a trained physician.
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/K162001 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162001: 1.5T and 3.0T 16 CH GE Shoulder Coils.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162001
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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