510(k) · Cleared
ClearedGE 3.0T General Purpose Flex Coil
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Medical Systems, Inc. · MOS Coil, Magnetic Resonance, Specialty
Cleared on Apr 10, 2003 as substantially equivalent to K923264 (General Electric Co., 1992) after a 14-day review. Its family tree reaches back 1 generation to 1992. 4 later devices descend from it.
- Decided
- Apr 10, 2003
- Review
- 14 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K923264 (1992). 4 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK923264 General Purpose Flex CoilGeneral Electric Co. · 1992
- This deviceK030953 GE 3.0T General Purpose Flex CoilGe Medical Systems, Inc. · 2003
- Descendant · cites it directly · 2 of its ownK061715 Mrgfus General Purpose and Breast CoilInsightec Txsonics, Inc. · 2006
- Descendant · 2 generations on · 1 of its ownK083434 TT1 General Purpose CoilTursiop Technologies, LLC · 2008
- Descendant · cites it directly · 0 of its ownK123681 1.5T 4CH Large Flex Coil, 1.5 4CH Small Flex CoilWipro GE Healthcare Private, Ltd. · 2013
- Descendant · 3 generations on · 0 of its ownK113280 Carotid Coil GE 1.5TTursiop Technologies, LLC · 2011
Most influential descendants
Showing 4 of 4 · See all- K061715Mrgfus General Purpose and Breast CoilInsightec Txsonics, Inc. · 2006 · cites it directly2descendants
- K083434TT1 General Purpose CoilTursiop Technologies, LLC · 2008 · 2 generations on1descendant
- K1236811.5T 4CH Large Flex Coil, 1.5 4CH Small Flex CoilWipro GE Healthcare Private, Ltd. · 2013 · cites it directly0descendants
- K113280Carotid Coil GE 1.5TTursiop Technologies, LLC · 2011 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K923264 | General Purpose Flex Coil | General Electric Co. | 1992 | — |
| 0 (this device) | K030953 | GE 3.0T General Purpose Flex Coil | Ge Medical Systems, Inc. | 2003 | — |
| +1 | K061715 | Mrgfus General Purpose and Breast Coil | Insightec Txsonics, Inc. | 2006 | — |
| +2 | K083434 | TT1 General Purpose Coil | Tursiop Technologies, LLC | 2008 | — |
| +1 | K123681 | 1.5T 4CH Large Flex Coil, 1.5 4CH Small Flex Coil | Wipro GE Healthcare Private, Ltd. | 2013 | — |
| +3 | K113280 | Carotid Coil GE 1.5T | Tursiop Technologies, LLC | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 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 |
|---|---|---|---|
| * | K923264 | General Purpose Flex CoilSummary page 1…000,90-MOS Marketed Device: The GE 3.OT General Purpose Flex Coil is substantially equivalent to the currently marketed GE Medical Systems 1.5T GP Flex coil M1085GP (K923264) Device Description: The GE 3.OT General Purpose Flex Coil is a modification of the existing 1.5T GP Flex Coil (K923264), to… | 1992 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 GE 3.OT General Purpose Flex Coil is designed to facilitate MR imaging of the Brachial Plexus, Unilateral Hip and Thigh. The GE 3.OT General Purpose Flex Coil will facilitate dynamic MR imaging of the joints of lower extremity (Knee and Ankle). This coil consists of two 5” x 6.5” surface coils coupled as a Helmholtz pair in a flexible package that can be wrapped around the anatomy of interest. This flexibility allows for the coil to be applied to a wider range of patients when compared to a similar coil in a rigid package. The coil is an option to the GE [email protected] whole body MR System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030953 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030953: GE 3.0T General Purpose Flex Coil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030953
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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