510(k) · Cleared
ClearedMatrix 3000 Flexible Spine Coil
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Us Asia Instruments, Inc. · LNH System, Nuclear Magnetic Resonance Imaging
Cleared on Feb 11, 1997 as substantially equivalent to K960497 (Philips Medical Systems (Cleveland), Inc., 1996) and 2 other predicates after a 76-day review. Its family tree reaches back 2 generations to 1989. 1 later device descends from it.
- Decided
- Feb 11, 1997
- Review
- 76 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K893619 (1989). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK893619 Vista MR 2055 HP SystemPhilips Medical Systems (Cleveland), Inc. · 1989
- 1 generation backK960497 Flexible Phased Array Spine CoilPhilips Medical Systems (Cleveland), Inc. · 1996
- This deviceK964753 Matrix 3000 Flexible Spine CoilUs Asia Instruments, Inc. · 1997
- Descendant · cites it directly · 0 of its ownK990007 Opart, Model MRT-600Toshiba America Mri, Inc. · 1999
Most influential descendants
Showing 1 of 1 · See all- K990007Opart, Model MRT-600Toshiba America Mri, Inc. · 1999 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K893619 | Vista MR 2055 HP System | Philips Medical Systems (Cleveland), Inc. | 1989 | — |
| −1 | K960497 | Flexible Phased Array Spine Coil | Philips Medical Systems (Cleveland), Inc. | 1996 | — |
| 0 (this device) | K964753 | Matrix 3000 Flexible Spine Coil | Us Asia Instruments, Inc. | 1997 | — |
| +1 | K990007 | Opart, Model MRT-600 | Toshiba America Mri, Inc. | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 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? (3)
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 |
|---|---|---|---|
| * | K960497 | Flexible Phased Array Spine CoilSummary page 3…s Parameter Matrix 3000 Flexible Spine Predicate Coil Intended Use Thoracic and Lumbar Spine Flexible Phased Array Spine Coil Imaging Applications Picker International (K960497) Indications for Use Identical to routine MRI Flexible Phased Array Spine Coil imaging Picker International (K960497) Profile 700… | 1996 |
| * | K943440 | Profile 7000 C-Spine CoilSummary page 3…ndications for Use Identical to routine MRI Flexible Phased Array Spine Coil imaging Picker International (K960497) Profile 7000 C-Spine Coils US ASIA Instruments, Inc. (K943440) Coil Enclosure Material Vinyl Fabric Flexible Phased Array Spine Coil Picker International (K960497) Coil Design Two channel r… | 1995 |
| * | K945827 | OutlookSummary page 3…F transmission Picker International (K960497) Coil elements and circuitry Same as other Outlook Coils are enclosed in a non-conductive | Picker International housing. ' (K945827) Radio Frequency Absorption Coil is a receive only coil and Profile 7000 C-Spine Coils does not transmit RF power. (K943440), US… | 1995 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K990007 | Opart, Model MRT-600 | 1999 | 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?
- The line of descent spans 8 years and passes through 2 companies; a new generation was cleared every 7.0 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K990007 (Toshiba America Mri, Inc., 1999) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K960497.
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 Spine Coil is a receive-only phased array RF coil, used for obtaining diagnostic images of the thoracic and lumbar spine in Magnetic Resonance Imaging systems. The indications for use are the same as for standard MR Imaging. The Matrix 3000 Flexible Spine Coil is designed for use with the Outlook (0.23Tesla) MRI scanner manufactured by Picker International Inc.
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/K964753 · printed Nov 5, 2026
Cite this page
510(k) Report. “K964753: Matrix 3000 Flexible Spine Coil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K964753
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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