510(k) · Cleared
ClearedVision 9000 Phased Array Torso 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 Oct 17, 2000 after a 64-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 7 later devices descend from it.
- Decided
- Oct 17, 2000
- Review
- 64 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 1 citing it directly.
- This deviceK002482 Vision 9000 Phased Array Torso CoilUsa Instruments, Inc. · 2000
- Descendant · cites it directly · 6 of its ownK013594 Body Array CoilUsa Instruments, Inc. · 2002
- Descendant · 2 generations on · 2 of its ownK024187 Spirit Iii Totalsense Cardiac CoilUsa Instruments, Inc. · 2003
- Descendant · 3 generations on · 1 of its ownK031172 Spirit Iii Totalsense Cardiac CoilUsa Instruments, Inc. · 2003
- Descendant · 2 generations on · 1 of its ownK030371 Prima Iii Totalsense Torso CoilUsa Instruments, Inc. · 2003 · Recalled
- Descendant · 3 generations on · 0 of its ownK103365 Discovery 3T 16 CH Body Array Coil (Anterior); Discovery 3T 16 CH…Ge Healthcare Coils (Usa Instruments, Inc.) · 2011
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K013594Body Array CoilUsa Instruments, Inc. · 2002 · cites it directly6descendants
- K024187Spirit Iii Totalsense Cardiac CoilUsa Instruments, Inc. · 2003 · 2 generations on2descendants
- K031172Spirit Iii Totalsense Cardiac CoilUsa Instruments, Inc. · 2003 · 3 generations on1descendant
- K030371Prima Iii Totalsense Torso CoilUsa Instruments, Inc. · 2003 · 2 generations on1descendant
- K103365Discovery 3T 16 CH Body Array Coil (Anterior); Discovery 3T 16 CH Body Array Coil…Ge Healthcare Coils (Usa Instruments, Inc.) · 2011 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K002482 | Vision 9000 Phased Array Torso Coil | Usa Instruments, Inc. | 2000 | — |
| +1 | K013594 | Body Array Coil | Usa Instruments, Inc. | 2002 | — |
| +2 | K024187 | Spirit Iii Totalsense Cardiac Coil | Usa Instruments, Inc. | 2003 | — |
| +3 | K031172 | Spirit Iii Totalsense Cardiac Coil | Usa Instruments, Inc. | 2003 | — |
| +2 | K030371 | Prima Iii Totalsense Torso Coil | Usa Instruments, Inc. | 2003 | 1 |
| +3 | K103365 | Discovery 3T 16 CH Body Array Coil (Anterior); Discovery 3T 16 CH Body Array… | Ge Healthcare Coils (Usa Instruments, Inc.) | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 4 | 0 |
| 2004 | 1 | 0 |
| 2011 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K013594 | Body Array Coil | 2002 | 6 |
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?
- Of its descendants, K013594 (Usa Instruments, Inc., 2002) has gone furthest, with 6 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 | — |
https://510kreport.com/device/K002482 · printed Nov 6, 2026
Cite this page
510(k) Report. “K002482: Vision 9000 Phased Array Torso Coil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002482
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026