510(k) · Cleared
ClearedPremier 7000 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 Apr 13, 1998 as substantially equivalent to K932693 (Philips Medical Systems (Cleveland), Inc., 1993) and 1 other predicate after an 87-day review. Its family tree reaches back 1 generation to 1991. 65 later devices descend from it.
- Decided
- Apr 13, 1998
- Review
- 87 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K911806 (1991). 2 ancestors in all. 65 later devices descend from it, 8 citing it directly.
- Root · 1 generation backK911806 Magnetic Resonance Diagnostic AccessoryGeneral Electric Co. · 1991
- This deviceK980157 Premier 7000 CTL Spine CoilUsa Instruments, Inc. · 1998
- Descendant · cites it directly · 51 of its ownK994345 Magna 5000 Phased Array CTL Spine CoilUsa Instruments, Inc. · 2000
- Descendant · 2 generations on · 45 of its ownK042236 G-SCANEsaote, S.p.A. · 2004
- Descendant · 3 generations on · 43 of its ownK060956 G-Scan-Model 9800020000, E-Scan Model 9800010000 and E-Scan…Esaote, S.p.A. · 2006
- Descendant · 2 generations on · 34 of its ownK063207 S-Scan Mri SystemEsaote, S.p.A. · 2006
- Descendant · 4 generations on · 32 of its ownK061429 Dynamic Mri Software Option for C-Scan, E-Scan XQ and E-Scan OperaEsaote, S.p.A. · 2006
Showing 5 of 65 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 65 · See all- K994345Magna 5000 Phased Array CTL Spine CoilUsa Instruments, Inc. · 2000 · cites it directly51descendants
- K042236G-SCANEsaote, S.p.A. · 2004 · 2 generations on45descendants
- K060956G-Scan-Model 9800020000, E-Scan Model 9800010000 and E-Scan…Esaote, S.p.A. · 2006 · 3 generations on43descendants
- K063207S-Scan Mri SystemEsaote, S.p.A. · 2006 · 2 generations on34descendants
- K061429Dynamic Mri Software Option for C-Scan, E-Scan XQ and E-Scan OperaEsaote, S.p.A. · 2006 · 4 generations on32descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K911806 | Magnetic Resonance Diagnostic Accessory | General Electric Co. | 1991 | — |
| 0 (this device) | K980157 | Premier 7000 CTL Spine Coil | Usa Instruments, Inc. | 1998 | — |
| +1 | K994345 | Magna 5000 Phased Array CTL Spine Coil | Usa Instruments, Inc. | 2000 | — |
| +2 | K042236 | G-SCAN | Esaote, S.p.A. | 2004 | — |
| +3 | K060956 | G-Scan-Model 9800020000, E-Scan Model 9800010000 and E-Scan… | Esaote, S.p.A. | 2006 | — |
| +2 | K063207 | S-Scan Mri System | Esaote, S.p.A. | 2006 | — |
| +4 | K061429 | Dynamic Mri Software Option for C-Scan, E-Scan XQ and E-Scan Opera | Esaote, S.p.A. | 2006 | — |
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 |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 4 | 0 |
| 2003 | 7 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 4 | 0 |
| 2007 | 1 | 0 |
| 2008 | 5 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 5 | 0 |
| 2012 | 7 | 0 |
| 2013 | 3 | 0 |
| 2015 | 4 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2019 | 4 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 2 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K932693 | Edge SystemSummary page 2…Premier 7000 Phased Array Spine Coil Same as Predicate Device Intended Use Imaging of the spine. Phased Array C/T/L Spine Coil, Edge MRI System Picker International (K932693) Magnetic Resonance Diagnostic Accessory (CTL Phased Array Spine Coil) GE (General Electric) (K911806) Indications for Use I… | 1993 |
| * | K911806 | Magnetic Resonance Diagnostic AccessorySummary page 2…ed Array C/T/L Spine Coil, Edge MRI System Picker International (K932693) Magnetic Resonance Diagnostic Accessory (CTL Phased Array Spine Coil) GE (General Electric) (K911806) Indications for Use Identical to routine MRI imaging Phased Array C/T/L Spine Coil, Edge MRI System Picker International (K93… | 1991 |
| † | K964531 | Profile 70000 Quadrature Volume Neck Coil | 1997 |
| † | K971246 | Leo 7000 Quadrature Knee Coil | 1997 |
| † | K962677 | Esteem 1.5T Mri System | 1996 |
| † | K972826 | Esteem 1.5T Mri System | 1997 |
| † | K944469 | General Purpose Flex Coil | 1995 |
| † | K972340 | Insight 7000 Phased Array Torso Coil | 1997 |
What descends from it? (65)
See all 658 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K994345 | Magna 5000 Phased Array CTL Spine Coil | 2000 | 51 |
| K983143 | Mark 5000 Phased Array Shoulder Coil | 1998 | 7 |
| K013595 | Premier Iii Phased Array CTL Spine Coil | 2002 | 3 |
| K030042 | Premier Iii Phased Array CTL Spine Coil | 2003 | 2 |
| K031366 | Premier 9000 8 Channel Phased Array CTL Spine Coil | 2003 | 0 |
| K031056 | Modification to Premier Iii Phased Array CTL Spine Coil | 2003 | 0 |
| K020268 | Isaac 1.5 T MR System | 2002 | 0 |
| K014086 | CTL Body / Spine Array Coil | 2002 | 0 |
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?
- None of the 2 ancestors has a recall.
- Of its descendants, K994345 (Usa Instruments, Inc., 2000) has gone furthest, with 51 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 Premier 7000 Phased Array Spine Coil is designed to provide Magnetic Resonance Images of the spine anatomy. The Premier 7000 Phased Array Spine Coil is designed for use with the GE MR’s Signa 1.5T scanner. Anatomic Regions: Spine Nuclei Excited: Hydrogen The indications for use are the same as for standard imaging: The Signa 1.5T system is indicated for use as an NMR device that produces images that: (1) correspond to the distribution of protons…
Read the full statement (128 words)
The Premier 7000 Phased Array Spine Coil is designed to provide Magnetic Resonance Images of the spine anatomy. The Premier 7000 Phased Array Spine Coil is designed for use with the GE MR’s Signa 1.5T scanner.
Anatomic Regions: Spine
Nuclei Excited: Hydrogen
The indications for use are the same as for standard imaging:
The Signa 1.5T 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/K980157 · printed Nov 4, 2026
Cite this page
510(k) Report. “K980157: Premier 7000 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/K980157
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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