510(k) · Cleared
ClearedGE 1.5T 8 Channel Torso 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 May 23, 2003 as substantially equivalent to K030495 (Ge Medical Systems, Inc., 2003) and 1 other predicate after a 36-day review. Its family tree reaches back 2 generations to 1997. 3 later devices descend from it.
- Decided
- May 23, 2003
- Review
- 36 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K971667 (1997). 5 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK971667 Cardiac Phased Array CoilGE Medical Systems · 1997
- 1 generation backK022669 8 Channel Cardiac Phased Array CoilGE Medical Systems · 2002
- This deviceK031209 GE 1.5T 8 Channel Torso CoilGe Medical Systems, Inc. · 2003
- Descendant · cites it directly · 1 of its ownK052584 1.5T 12 Channel Body ArrayUsa Instruments, Inc. · 2005
- Descendant · 2 generations on · 0 of its ownK101492 8 Channel Cardiac Phased Array CoilGe Healthcare Coils (Usa Instruments, Inc.) · 2010
- Descendant · cites it directly · 0 of its ownK073236 Neocoil 3.0T 32-Channel Torso Array Coil for GENeocoil · 2007
Most influential descendants
Showing 3 of 3 · See all- K0525841.5T 12 Channel Body ArrayUsa Instruments, Inc. · 2005 · cites it directly1descendant
- K1014928 Channel Cardiac Phased Array CoilGe Healthcare Coils (Usa Instruments, Inc.) · 2010 · 2 generations on0descendants
- K073236Neocoil 3.0T 32-Channel Torso Array Coil for GENeocoil · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K971667 | Cardiac Phased Array Coil | GE Medical Systems | 1997 | — |
| −1 | K022669 | 8 Channel Cardiac Phased Array Coil | GE Medical Systems | 2002 | — |
| 0 (this device) | K031209 | GE 1.5T 8 Channel Torso Coil | Ge Medical Systems, Inc. | 2003 | — |
| +1 | K052584 | 1.5T 12 Channel Body Array | Usa Instruments, Inc. | 2005 | — |
| +2 | K101492 | 8 Channel Cardiac Phased Array Coil | Ge Healthcare Coils (Usa Instruments, Inc.) | 2010 | — |
| +1 | K073236 | Neocoil 3.0T 32-Channel Torso Array Coil for GE | Neocoil | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 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 |
|---|---|---|---|
| * | K030495 | 3.0T Torso Phased Array CoilSummary page 1…21 CFR 892.1000,90-MOS Marketed Device: The GE I .5T 8 Channel Torso Coil is substantially equivalent to the currently marketed GE the 3.OT Torso Phased Array Coil (K030495) with the integration of the 8 channel technology in the currently marketed GE 8 Channel Cardiac Phased Array Coil (K022669).… | 2003 |
| * | K022669 | 8 Channel Cardiac Phased Array CoilSummary page 1…rketed GE the 3.OT Torso Phased Array Coil (K030495) with the integration of the 8 channel technology in the currently marketed GE 8 Channel Cardiac Phased Array Coil (K022669). Device Description: The GE 1.5T 8 Channel Torso Coil is a 12 element coil with integrated preamplifiers that provides optimi… | 2002 |
What descends from it? (3)
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?
- The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 5.1 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K052584 (Usa Instruments, Inc., 2005) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K030495.
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 1.5T 8 Channel Torso Coil is intended to be used in the abdomen, pelvis and chest regions for 2D and 3D Magnetic Resonance imaging and Parallel body imaging
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031209 · printed Nov 4, 2026
Cite this page
510(k) Report. “K031209: GE 1.5T 8 Channel Torso Coil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K031209
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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