510(k) · Cleared
ClearedFlexible Phased Array Spine Coil
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems (Cleveland), Inc. · LNH System, Nuclear Magnetic Resonance Imaging
Cleared on Jul 5, 1996 as substantially equivalent to K893619 (Philips Medical Systems (Cleveland), Inc., 1989) and 1 other predicate after a 154-day review. Its family tree reaches back 1 generation to 1989. 39 later devices descend from it.
- Decided
- Jul 5, 1996
- Review
- 154 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K893619 (1989). 2 ancestors in all. 39 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK893619 Vista MR 2055 HP SystemPhilips Medical Systems (Cleveland), Inc. · 1989
- This deviceK960497 Flexible Phased Array Spine CoilPhilips Medical Systems (Cleveland), Inc. · 1996
- Descendant · cites it directly · 26 of its ownK971246 Leo 7000 Quadrature Knee CoilUsa Instruments, Inc. · 1997
- Descendant · 2 generations on · 22 of its ownK023982 Leo Iii TX/RX Quadrature Knee Coil; Alpha Iii TX/RX Quadrature Wrist…Usa Instruments, Inc. · 2003
- Descendant · 3 generations on · 21 of its ownK082636 TXRX 15CH Knee Coil (1.5T and 3T), TXRX CP Extremity Coil 3TQuality Electrodynamics · 2008 · Recalled
- Descendant · 4 generations on · 12 of its ownK100141 14-Channel Extremity Coil for Magnetom EssenzaSiemens Medical Solutions USA, Inc. · 2010
- Descendant · 5 generations on · 11 of its ownK130262 Magnetom Essenza with Syngo MR D14Siemens Medical Solutions USA, Inc. · 2013
Showing 5 of 39 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 39 · See all- K971246Leo 7000 Quadrature Knee CoilUsa Instruments, Inc. · 1997 · cites it directly26descendants
- K023982Leo Iii TX/RX Quadrature Knee Coil; Alpha Iii TX/RX Quadrature Wrist CoilUsa Instruments, Inc. · 2003 · 2 generations on22descendants
- K082636TXRX 15CH Knee Coil (1.5T and 3T), TXRX CP Extremity Coil 3TQuality Electrodynamics · 2008 · 3 generations on21descendants
- K10014114-Channel Extremity Coil for Magnetom EssenzaSiemens Medical Solutions USA, Inc. · 2010 · 4 generations on12descendants
- K130262Magnetom Essenza with Syngo MR D14Siemens Medical Solutions USA, Inc. · 2013 · 5 generations on11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K893619 | Vista MR 2055 HP System | Philips Medical Systems (Cleveland), Inc. | 1989 | — |
| 0 (this device) | K960497 | Flexible Phased Array Spine Coil | Philips Medical Systems (Cleveland), Inc. | 1996 | — |
| +1 | K971246 | Leo 7000 Quadrature Knee Coil | Usa Instruments, Inc. | 1997 | — |
| +2 | K023982 | Leo Iii TX/RX Quadrature Knee Coil; Alpha Iii TX/RX Quadrature Wrist Coil | Usa Instruments, Inc. | 2003 | — |
| +3 | K082636 | TXRX 15CH Knee Coil (1.5T and 3T), TXRX CP Extremity Coil 3T | Quality Electrodynamics | 2008 | 8 |
| +4 | K100141 | 14-Channel Extremity Coil for Magnetom Essenza | Siemens Medical Solutions USA, Inc. | 2010 | — |
| +5 | K130262 | Magnetom Essenza with Syngo MR D14 | Siemens Medical Solutions USA, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 4 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 6 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 LNH? 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 LNH device
- #1 K213693 MAGNETOM Vida with syngo MR XA50Ascore 23.0 · 18 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 |
|---|---|---|---|
| * | K893619 | Vista MR 2055 HP SystemSummary page 2…IAL EQUIVALENCE CHART L PARAMETER i FLEXIBLE SPINE COIL PREDICATE Coil Enclosure Material Vinyl fabric Same as material uses in Picker Extended Coverage Head Coil (K893619) Coil Design Two-channel receive-only Outlook Body Coil is a receive- phased array coil only phased array coil (K945827) Decoupl… | 1989 |
| * | K945827 | OutlookSummary page 2…rial uses in Picker Extended Coverage Head Coil (K893619) Coil Design Two-channel receive-only Outlook Body Coil is a receive- phased array coil only phased array coil (K945827) Decoupling Active PIN diode decoupling Same as Body Coil for Outlook (K945827) Formation of Resonant Loops The length of the… | 1995 |
What descends from it? (39)
See all 395 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?
- None of the 2 ancestors has a recall.
- Of its descendants, K971246 (Usa Instruments, Inc., 1997) has gone furthest, with 26 descendants of its own.
How does its category compare?
All LNH devicesLNH System, Nuclear Magnetic Resonance Imaging: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LNH
26in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LNH
122in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LNH
8in 2025
Class I (8 since 2007) Class II/III not classified
Adverse event reports per year · LNH
1,263in 2025
MAUDE reports naming product code LNH, 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 | 12 | 35 | 25 | 114 |
| 2008 | 19 | 53 | 12 | 167 |
| 2009 | 17 | 70 | 7 | 194 |
| 2010 | 12 | 94 | 17 | 165 |
| 2011 | 16 | 81 | 11 | 182 |
| 2012 | 22 | 89 | 5 | 170 |
| 2013 | 19 | 108 | 2 | 107 |
| 2014 | 17 | 108 | 13 | 119 |
| 2015 | 19 | 140 | 12 (2) | 113 |
| 2016 | 20 | 108 | 1 | 135 |
| 2017 | 18 | 98 | 0 | 121 |
| 2018 | 29 | 128 | 71 | 158 |
| 2019 | 26 | 62 | 5 | 158 |
| 2020 | 32 | 121 | 4 | 98 |
| 2021 | 27 | 87 | 41 | 84 |
| 2022 | 30 | 74 | 13 | 138 |
| 2023 | 30 | 124 | 10 (1) | 159 |
| 2024 | 26 | 104 | 4 | 281 |
| 2025 | 26 | 122 | 8 (5) | 1,263 |
| 2026 | 24 | 126 | 43 | — |
What is it indicated for?
The Flexible Phased Array Spine Coil is designed to provide coverage of the thoracic and lumbar spinal regions of the body. The indications for use are the same as for standard MR imaging.
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/K960497 · printed Nov 6, 2026
Cite this page
510(k) Report. “K960497: Flexible Phased Array 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/K960497
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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