510(k) · Cleared
ClearedPremier Iii 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 May 29, 2003 as substantially equivalent to K030042 (Usa Instruments, Inc., 2003) after a 49-day review. Its family tree reaches back 3 generations to 1991.
- Decided
- May 29, 2003
- Review
- 49 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K911806 (1991). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK911806 Magnetic Resonance Diagnostic AccessoryGeneral Electric Co. · 1991
- 2 generations backK980157 Premier 7000 CTL Spine CoilUsa Instruments, Inc. · 1998
- 1 generation backK030042 Premier Iii Phased Array CTL Spine CoilUsa Instruments, Inc. · 2003
- This deviceK031139 Premier Iii Phased Array CTL Spine CoilUsa Instruments, Inc. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K911806 | Magnetic Resonance Diagnostic Accessory | General Electric Co. | 1991 | — |
| −2 | K980157 | Premier 7000 CTL Spine Coil | Usa Instruments, Inc. | 1998 | — |
| −1 | K030042 | Premier Iii Phased Array CTL Spine Coil | Usa Instruments, Inc. | 2003 | — |
| 0 (this device) | K031139 | Premier Iii 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 |
|---|---|---|---|
| * | K030042 | Premier Iii Phased Array CTL Spine CoilSummary page 2…the Premier Ill Phased Array CTL Imaging of the spine. Spine Coil manufactured by USA Instruments, Inc. (K030042) Indications for Use: -Similar to the Premier Ill Phased Array CTL Identical to routine MRI imaging… | 2003 |
| † | K980157 | Premier 7000 CTL Spine Coil | 1998 |
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 4.9 years on median.
- None of the 4 ancestors has a recall.
- 1 other device also cites its predicate K030042.
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 Ill Phased Array CTL Spine Coil is designed to provide Magnetic Resonance Images of the cervical, thoracic, and lumbar regions of the spine. The Premier Ill Phased Array CTL Spine Coil is designed for use with the Philips 3.OT lntera MR scanner manufactured by Philips Medical Systems, Inc. Anatomic Regions: cervical, thoracic, and lumbar regions of the spine. Nuclei Excited: Hydrogen The indications for use are the same as for standard…
Read the full statement (149 words)
The Premier Ill Phased Array CTL Spine Coil is designed to provide Magnetic Resonance Images of the cervical, thoracic, and lumbar regions of the spine. The Premier Ill Phased Array CTL Spine Coil is designed for use with the Philips 3.OT lntera MR scanner manufactured by Philips Medical Systems, Inc.
Anatomic Regions: cervical, thoracic, and lumbar regions of the spine.
Nuclei Excited: Hydrogen
The indications for use are the same as for standard imaging:
The 3.OT MRI system is indicated for use as an NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR signal, (2) depend upon NMR parameters (proton density, spin lattice relaxation time T1, 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 images 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/K031139 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031139: Premier Iii 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/K031139
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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