510(k) · Cleared
ClearedDiscovery 3T 16 CH Body Array Coil (Anterior); Discovery 3T 16 CH Body Array Coil (Posterior); Discovery 3T 32 CH Body a
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Healthcare Coils (Usa Instruments, Inc.) · MOS Coil, Magnetic Resonance, Specialty
Cleared on Jan 12, 2011 as substantially equivalent to K030371 (Usa Instruments, Inc., 2003) after a 56-day review. Its family tree reaches back 3 generations to 2000.
- Decided
- Jan 12, 2011
- Review
- 56 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K001209 (2000). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK001209 Insight Plus 9000 Phased Array Torso and Pelvis CoilUsa Instruments, Inc. · 2000
- 2 generations backK013594 Body Array CoilUsa Instruments, Inc. · 2002
- 1 generation backK030371 Prima Iii Totalsense Torso CoilUsa Instruments, Inc. · 2003 · Recalled
- This deviceK103365 Discovery 3T 16 CH Body Array Coil (Anterior); Discovery 3T 16 CH…Ge Healthcare Coils (Usa Instruments, Inc.) · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K001209 | Insight Plus 9000 Phased Array Torso and Pelvis Coil | Usa Instruments, Inc. | 2000 | — |
| −2 | K013594 | Body Array Coil | Usa Instruments, Inc. | 2002 | — |
| −1 | K030371 | Prima Iii Totalsense Torso Coil | Usa Instruments, Inc. | 2003 | 1 |
| 0 (this device) | K103365 | Discovery 3T 16 CH Body Array Coil (Anterior); Discovery 3T 16 CH Body Array… | Ge Healthcare Coils (Usa Instruments, Inc.) | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 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 |
|---|---|---|---|
| * | K030371 | Prima Iii Totalsense Torso CoilSummary page 1…tic resonance, specialty Classification Names: 21 CFR 892. 1000, Magnetic resonance diagnostic device Product Code: 90M05 Predicate Device(s): K030371, USA Instruments Prima III TotaISENSE Torso Coil Page 5-2… | 2003 |
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?
- The line of descent spans 11 years and passes through 2 companies; a new generation was cleared every 1.6 years on median.
- 1 of the 4 ancestors has a recall of any class.
How does its category compare?
All MOS devicesMOS Coil, Magnetic Resonance, Specialty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 Discovery 3T 16 Ch Body Array Coil and Discovery 3T 32 Ch Body Array Coil are receive-only RIF Coils designed for use with 3.OT MRI systems manufactured by GE Healthcare. The indications for use include chgst, cardiac, abdomen, torso, pelvis, prostate, hips, and long bone imaging. The nucleus detected is hydrogen.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103365 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103365: Discovery 3T 16 CH Body Array Coil (Anterior); Discovery 3T 16 CH Body Array Coil (Posterior); Discovery 3T 32 CH Body a.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103365
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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