510(k) · Cleared
ClearedPremier 9000 8 Channel Phased Array CTL Spine Coil
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 Jul 11, 2003 as substantially equivalent to K980157 (Usa Instruments, Inc., 1998) after a 72-day review. Its family tree reaches back 2 generations to 1991.
- Decided
- Jul 11, 2003
- Review
- 72 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K911806 (1991). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K911806 | Magnetic Resonance Diagnostic Accessory | General Electric Co. | 1991 | — |
| −1 | K980157 | Premier 7000 CTL Spine Coil | Usa Instruments, Inc. | 1998 | — |
| 0 (this device) | K031366 | Premier 9000 8 Channel Phased Array CTL Spine Coil | Usa Instruments, Inc. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 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 |
|---|---|---|---|
| * | K980157 | Premier 7000 CTL Spine CoilSummary page 2…sed As-ray CTL Imaging of the spine. Spine Coil manufactured by USA Instridments, Inc. (K980157) Indications for Use: -Similar to the Premier 7000 Phased Array CTL Identical to routine… | 1998 |
| † | K001210 | HI-Res 9000 Phased Array Carotid Coil | 2000 |
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 12 years and passes through 2 companies; a new generation was cleared every 6.8 years on median.
- None of the 3 ancestors has a recall.
- 7 other devices also cite its predicate K980157.
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 Premier 9000 8 Channel Phased Array CTL Coil is designed to provide Magnetic Resonance Images of the cervical, thoracic: and lumbar regions of the spine. The Premier 9000 8 Channel Phased Array CTL Coil is designed for use with the GE Excite 1.5T scanner manufactured by GEi Medical Systems, Inc. The indications for use are the same as for standard imaging: The 1.5T MRI system is indicated for use as an NMR device that producles images that: (1)…
Read the full statement (139 words)
The Premier 9000 8 Channel Phased Array CTL Coil is designed to provide Magnetic Resonance Images of the cervical, thoracic: and lumbar regions of the spine. The Premier 9000 8 Channel Phased Array CTL Coil is designed for use with the GE Excite 1.5T scanner manufactured by GEi Medical Systems, Inc.
The indications for use are the same as for standard imaging:
The 1.5T MRI system is indicated for use as an NMR device that producles images that: (1) correspond to the distribution of protons exhibiting NMR signal, (2) depend upon NMR parameters (proton density, spin lattice relaxation time T I , spin-spin relaxation time T2) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these imiages yield information that can be useful in the determination of a diagnosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031366 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031366: Premier 9000 8 Channel Phased Array CTL 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/K031366
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