510(k) · Cleared
Cleared3.0T 16 Channel Head Neck Spine Coil
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 Nov 25, 2009 as substantially equivalent to K052916 (Usa Instruments, Inc., 2005) after a 29-day review. Its family tree reaches back 3 generations to 2000. 3 later devices descend from it.
- Decided
- Nov 25, 2009
- Review
- 29 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K001870 (2000). 3 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK001870 Millennium 9000 Phased Array Neurovascular CoilUsa Instruments, Inc. · 2000
- 2 generations backK032618 3.0T 8 Channel Neurovascular (NV) Array CoilUsa Instruments, Inc. · 2003
- 1 generation backK052916 Usa Instruments 3.0T Brain/Spine ArrayUsa Instruments, Inc. · 2005 · Recalled
- This deviceK093348 3.0T 16 Channel Head Neck Spine CoilGe Healthcare Coils (Usa Instruments, Inc.) · 2009
- Descendant · cites it directly · 2 of its ownK113365 Infant ArrayAdvanced Imaging Research Dba Sree Medical Systems · 2012
- Descendant · 2 generations on · 1 of its ownK140998 Pediatric 16, A1.5T Tim Coil/Pediatric 16, A3T Tim CoilQuality Electrodynamics, LLC · 2014
- Descendant · 3 generations on · 0 of its ownK183186 Head Coil – 12, Head Coil – 32, Carotid Coil – 8, Temporomandibular…Shanghai United Imaging Healthcare Co., Ltd. · 2019
Most influential descendants
Showing 3 of 3 · See all- K113365Infant ArrayAdvanced Imaging Research Dba Sree Medical Systems · 2012 · cites it directly2descendants
- K140998Pediatric 16, A1.5T Tim Coil/Pediatric 16, A3T Tim CoilQuality Electrodynamics, LLC · 2014 · 2 generations on1descendant
- K183186Head Coil – 12, Head Coil – 32, Carotid Coil – 8, Temporomandibular Joint Coil – 4…Shanghai United Imaging Healthcare Co., Ltd. · 2019 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K001870 | Millennium 9000 Phased Array Neurovascular Coil | Usa Instruments, Inc. | 2000 | — |
| −2 | K032618 | 3.0T 8 Channel Neurovascular (NV) Array Coil | Usa Instruments, Inc. | 2003 | — |
| −1 | K052916 | Usa Instruments 3.0T Brain/Spine Array | Usa Instruments, Inc. | 2005 | 1 |
| 0 (this device) | K093348 | 3.0T 16 Channel Head Neck Spine Coil | Ge Healthcare Coils (Usa Instruments, Inc.) | 2009 | — |
| +1 | K113365 | Infant Array | Advanced Imaging Research Dba Sree Medical Systems | 2012 | — |
| +2 | K140998 | Pediatric 16, A1.5T Tim Coil/Pediatric 16, A3T Tim Coil | Quality Electrodynamics, LLC | 2014 | — |
| +3 | K183186 | Head Coil – 12, Head Coil – 32, Carotid Coil – 8, Temporomandibular Joint Coil… | Shanghai United Imaging Healthcare Co., Ltd. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2019 | 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K052916 | Usa Instruments 3.0T Brain/Spine ArraySummary page 2…Product Code: 90MOS Predicate Device(s): (1) 3.OT 16 Channel Brain/Spine (Neurovascular) Array Coil (K052916) (2) 1.5T 16 Channel Brain/Spine Coil (K052612) Device Description: The 3.OT Hea… | 2005 |
| Kept off the family tree | K052612 | FDA’s K052612 is Disposable Powder Free Vinyl Exam Gloves with Vitamin Complex, Nopal and… Our reading of the summary gave K052612, FDA’s number for Disposable Powder Free Vinyl Exam Gloves with Vitamin… (Shanghai Antares Industries, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “1.5T 16 Channel Brain/Spine Coil”. Kept off the family tree. Summary page 2…3.OT 16 Channel Brain/Spine (Neurovascular) Array Coil (K052916) (2) 1.5T 16 Channel Brain/Spine Coil (K052612) Device Description: The 3.OT Head Neck and Spine CoilI s a receive-only 16-channel,… | 2005 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K113365 | Infant Array | 2012 | 2 |
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 9 years and passes through 2 companies; a new generation was cleared every 3.1 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K113365 (Advanced Imaging Research Dba Sree Medical Systems, 2012) has gone furthest, with 2 descendants of its own.
How does its category compare?
All MOS devicesMOS Coil, Magnetic Resonance, Specialty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 GE 3.OT 16 Channel Head Neck Spine Coil is a receive-only RF coil designed for use with the 3.OT MIR system manufactured by GE Healthcare. The coil is intended for imaging of the brain; cervical, thoracic and lumbar spines; as well as the soft tissues and vasculature of the head, neck, and upper chest. The nucleus excited is hydrogen.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093348 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093348: 3.0T 16 Channel Head Neck Spine Coil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093348
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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