510(k) · Cleared
ClearedGE Signa Profile 6 Inch GP Coil
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Medical Systems, LLC · MOS Coil, Magnetic Resonance, Specialty
Cleared on Jul 26, 2004 as substantially equivalent to K972296 (Ge Medical Systems, Inc., 1997) after a 10-day review. Its family tree reaches back 1 generation to 1997.
- Decided
- Jul 26, 2004
- Review
- 10 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K972296 (1997). No later device cites it as a predicate yet.
- Root · 1 generation backK972296 Magnetic Resonance Diagnostic SystemGe Medical Systems, Inc. · 1997
- This deviceK041921 GE Signa Profile 6 Inch GP CoilGe Medical Systems, LLC · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K972296 | Magnetic Resonance Diagnostic System | Ge Medical Systems, Inc. | 1997 | — |
| 0 (this device) | K041921 | GE Signa Profile 6 Inch GP Coil | Ge Medical Systems, LLC | 2004 | — |
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 |
|---|---|---|---|
| * | K972296 | Magnetic Resonance Diagnostic SystemSummary page 1…892.1000, 90-MOS Marketed Device The 0.2T 6-inch receive only GP coil is substantially equivalent to the currently marketed GE Signa Profile 9 inch coil (K972296), which is also a coil for O.2T MR imaging. Device Description The GE 0.2T 6-inch GP Coil is designed for MR imaging of… | 1997 |
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?
- Its one ancestor has no recall.
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 GE 0.2T 6-inch GP Coil is a 2-turn solenoid receive only coil designed for MR imaging. The coil has a soft pad, which helps to place the position to be examined in the center of the coil and provides comfort as well. The coil is a general-purpose coil that can be used to image the Cervical Spine, the neck, shoulder, and other extremity anatomy. The coil connects to the Signa Profile MRI system by way of the interface connector.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041921 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041921: GE Signa Profile 6 Inch GP Coil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041921
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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