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 Jan 22, 2002 as substantially equivalent to K980157 (Usa Instruments, Inc., 1998) and 1 other predicate after an 84-day review. Its family tree reaches back 3 generations to 1991. 3 later devices descend from it.
- Decided
- Jan 22, 2002
- Review
- 84 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K911806 (1991). 4 ancestors in all. 3 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK911806 Magnetic Resonance Diagnostic AccessoryGeneral Electric Co. · 1991
- 2 generations backK980157 Premier 7000 CTL Spine CoilUsa Instruments, Inc. · 1998
- 1 generation backK994345 Magna 5000 Phased Array CTL Spine CoilUsa Instruments, Inc. · 2000
- This deviceK013595 Premier Iii Phased Array CTL Spine CoilUsa Instruments, Inc. · 2002
- Descendant · cites it directly · 0 of its ownK032538 3.0T 8-Channel Cervical-Thoracic-Lumbar (CTL) Array CoilUsa Instruments, Inc. · 2003
- Descendant · cites it directly · 0 of its ownK032474 3.0T 4-Channel Cervico-Thoracic-Lumbar (CTL) Array CoilUsa Instruments, Inc. · 2003
- Descendant · cites it directly · 0 of its ownK031056 Modification to Premier Iii Phased Array CTL Spine CoilUsa Instruments, Inc. · 2003
Most influential descendants
Showing 3 of 3 · See all- K0325383.0T 8-Channel Cervical-Thoracic-Lumbar (CTL) Array CoilUsa Instruments, Inc. · 2003 · cites it directly0descendants
- K0324743.0T 4-Channel Cervico-Thoracic-Lumbar (CTL) Array CoilUsa Instruments, Inc. · 2003 · cites it directly0descendants
- K031056Modification to Premier Iii Phased Array CTL Spine CoilUsa Instruments, Inc. · 2003 · cites it directly0descendants
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 | K994345 | Magna 5000 Phased Array CTL Spine Coil | Usa Instruments, Inc. | 2000 | — |
| 0 (this device) | K013595 | Premier Iii Phased Array CTL Spine Coil | Usa Instruments, Inc. | 2002 | — |
| +1 | K032538 | 3.0T 8-Channel Cervical-Thoracic-Lumbar (CTL) Array Coil | Usa Instruments, Inc. | 2003 | — |
| +1 | K032474 | 3.0T 4-Channel Cervico-Thoracic-Lumbar (CTL) Array Coil | Usa Instruments, Inc. | 2003 | — |
| +1 | K031056 | Modification to 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 3 | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K980157 | Premier 7000 CTL Spine CoilSummary page 2…redicate device or other 510(K) cleared product Intended Use: Imaging of the spine. -Similar to the Premier 7000 C/T/L Spine Coil manufacture by USA Instruments, Inc. (K980157) -Similar to the Magna 5000 CTL Spine Coil manufactured by USA Instruments, Inc. (K994345) Indications for Use: |dentical to rou… | 1998 |
| * | K994345 | Magna 5000 Phased Array CTL Spine CoilSummary page 2…ilar to the Premier 7000 C/T/L Spine Coil manufacture by USA Instruments, Inc. (K980157) -Similar to the Magna 5000 CTL Spine Coil manufactured by USA Instruments, Inc. (K994345) Indications for Use: |dentical to routine MRI imaging -Similar to the Premier 7000 C/T/L Spine Coil manufacture by USA Instrum… | 2000 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 1.9 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K032538 (Usa Instruments, Inc., 2003) has gone furthest, with 0 descendants of its own.
- 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 I.I( Phased Array CTL Spine Coil is designed to provide Magnetic Resonance Images of the spine anatomy. The Premier [li Phased Array CTL Spine Coil is designed for use with the GE Medical Systems 3.0Tesla scanner. Anatomic Regions: Spine Nuclei Excited: Hydrogen The indications for use are the same as for standard imaging: The GE Medical Systems 3.0Tesla system is indicated for use as an NMR device that produces images that: (1) correspond to…
Read the full statement (132 words)
The Premier I.I( Phased Array CTL Spine Coil is designed
to provide Magnetic Resonance Images of the spine anatomy. The Premier [li
Phased Array CTL Spine Coil is designed for use with the GE Medical Systems
3.0Tesla scanner.
Anatomic Regions: Spine
Nuclei Excited: Hydrogen
The indications for use are the same as for standard imaging:
The GE Medical Systems 3.0Tesla 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K013595 · printed Nov 4, 2026
Cite this page
510(k) Report. “K013595: Premier Iii Phased Array CTL Spine Coil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013595
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026