510(k) · Cleared
Recalled · 2006Usa Instruments 3.0T Brain/Spine Array
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Usa Instruments, Inc. · MOS Coil, Magnetic Resonance, Specialty
Cleared on Nov 9, 2005 as substantially equivalent to K032618 (Usa Instruments, Inc., 2003) after a 23-day review. Its family tree reaches back 2 generations to 2000. 4 later devices descend from it. It has been recalled once.
- Decided
- Nov 9, 2005
- Review
- 23 days
- Class
- Class II
- Product code
- MOS
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K001870 (2000). 4 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK001870 Millennium 9000 Phased Array Neurovascular CoilUsa Instruments, Inc. · 2000
- 1 generation backK032618 3.0T 8 Channel Neurovascular (NV) Array CoilUsa Instruments, Inc. · 2003
- This deviceK052916 Usa Instruments 3.0T Brain/Spine ArrayUsa Instruments, Inc. · 2005
- Descendant · cites it directly · 3 of its ownK093348 3.0T 16 Channel Head Neck Spine CoilGe Healthcare Coils (Usa Instruments, Inc.) · 2009
- Descendant · 2 generations on · 2 of its ownK113365 Infant ArrayAdvanced Imaging Research Dba Sree Medical Systems · 2012
- Descendant · 3 generations on · 1 of its ownK140998 Pediatric 16, A1.5T Tim Coil/Pediatric 16, A3T Tim CoilQuality Electrodynamics, LLC · 2014
- Descendant · 4 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 4 of 4 · See all- K0933483.0T 16 Channel Head Neck Spine CoilGe Healthcare Coils (Usa Instruments, Inc.) · 2009 · cites it directly3descendants
- K113365Infant ArrayAdvanced Imaging Research Dba Sree Medical Systems · 2012 · 2 generations on2descendants
- K140998Pediatric 16, A1.5T Tim Coil/Pediatric 16, A3T Tim CoilQuality Electrodynamics, LLC · 2014 · 3 generations on1descendant
- K183186Head Coil – 12, Head Coil – 32, Carotid Coil – 8, Temporomandibular Joint Coil – 4…Shanghai United Imaging Healthcare Co., Ltd. · 2019 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K001870 | Millennium 9000 Phased Array Neurovascular Coil | Usa Instruments, Inc. | 2000 | — |
| −1 | K032618 | 3.0T 8 Channel Neurovascular (NV) Array Coil | Usa Instruments, Inc. | 2003 | — |
| 0 (this device) | K052916 | Usa Instruments 3.0T Brain/Spine Array | Usa Instruments, Inc. | 2005 | — |
| +1 | K093348 | 3.0T 16 Channel Head Neck Spine Coil | Ge Healthcare Coils (Usa Instruments, Inc.) | 2009 | — |
| +2 | K113365 | Infant Array | Advanced Imaging Research Dba Sree Medical Systems | 2012 | — |
| +3 | K140998 | Pediatric 16, A1.5T Tim Coil/Pediatric 16, A3T Tim Coil | Quality Electrodynamics, LLC | 2014 | — |
| +4 | 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 |
|---|---|---|
| 2009 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K032618 | 3.0T 8 Channel Neurovascular (NV) Array CoilSummary page 1…modification of the existing cleared USA Instruments 3.OT 8 Channel Neurovascular Array coil (K032618) with the main difference being the physically integration of the antenna and shape of the… | 2003 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K093348 | 3.0T 16 Channel Head Neck Spine Coil | 2009 | 3 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 20, 2006 | Not classified | Z-0164-2007 | Other | The firm determined that certain potential conditions for use of their medical device, outside of recommended practices, or operating manual descriptions, could result in a localized RF burn and/or electrical shock to a patient on which… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 5 years and passes through 1 company; a new generation was cleared every 3.1 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K093348 (Ge Healthcare Coils (Usa Instruments, Inc.), 2009) has gone furthest, with 3 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.
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 3.OT Brain / Spine Array Coil is designed for use with the Excite 3.OT MRI system manufactured by GE Healthcare. The coil is for imaging of the brain, cervical spine, soft tissues and vasculature of the head, neck, upper chest, thoracic and lumbar spine. The nucleus excited is hydrogen.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052916 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052916: Usa Instruments 3.0T Brain/Spine Array.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052916
Report an extraction error
Are you the manufacturer?
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