510(k) · Cleared
ClearedGore 3.0T Torso Array
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
W. L. Gore & Associates, Inc. · MOS Coil, Magnetic Resonance, Specialty
Cleared on Nov 18, 2002 as substantially equivalent to K003613 (GE Medical Systems, 2001) and 1 other predicate after a 17-day review. Its family tree reaches back 1 generation to 1991.
- Decided
- Nov 18, 2002
- Review
- 17 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K911806 (1991). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK911806 Magnetic Resonance Diagnostic AccessoryGeneral Electric Co. · 1991
- This deviceK023679 Gore 3.0T Torso ArrayW. L. Gore & Associates, Inc. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K911806 | Magnetic Resonance Diagnostic Accessory | General Electric Co. | 1991 | — |
| 0 (this device) | K023679 | Gore 3.0T Torso Array | W. L. Gore & Associates, Inc. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 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 |
|---|---|---|---|
| * | K003613 | 3.0.T Signa VH/I (T/R) Body Imaging CoilSummary page 1…Device Name: Coil, Magnetic Resonance, Specialty c. Identification of Predicate Devices: The GE 3.OT Transmitmeceive Body Imaging Coil (K003613) and the GE 1.5T Torso Array (K911806) are the predicate devices, which were found to b… | 2001 |
| * | K911806 | Magnetic Resonance Diagnostic AccessorySummary page 1…c. Identification of Predicate Devices: The GE 3.OT Transmitmeceive Body Imaging Coil (K003613) and the GE 1.5T Torso Array (K911806) are the predicate devices, which were found to be substantially equivalent through the… | 1991 |
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?
- None of the 2 ancestors has a recall.
- 2 other devices also cite its predicate K003613.
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 Gore 3.0T Torso Array is intended for multiple imaging applications with GE Signa(R) 3.0T MR Systems. It will allow for high resolution images of the thorax, abdomen, pelvis, and spine.
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/K023679 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023679: Gore 3.0T Torso Array.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023679
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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