510(k) · Cleared
ClearedChampion 5000 Peripheral Vascular 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 Dec 23, 2002 as substantially equivalent to K982339 (Usa Instruments, Inc., 1998) after an 84-day review. Its family tree reaches back 2 generations to 1997. 1 later device descends from it.
- Decided
- Dec 23, 2002
- Review
- 84 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K964813 (1997). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK964813 Model 675GE-64 Peripheral Vascular Coil Consisting of Model…Medical Advances, Inc. · 1997
- 1 generation backK982339 Flow 7000 Peripheral Vascular CoilUsa Instruments, Inc. · 1998
- This deviceK023247 Champion 5000 Peripheral Vascular CoilUsa Instruments, Inc. · 2002
- Descendant · cites it directly · 0 of its ownK042207 11000 Rapture Phased Array Peripheral Vascular CoilUsa Instruments, Inc. · 2004
Most influential descendants
Showing 1 of 1 · See all- K04220711000 Rapture Phased Array Peripheral Vascular CoilUsa Instruments, Inc. · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K964813 | Model 675GE-64 Peripheral Vascular Coil Consisting of Model 665GE-64: Lower… | Medical Advances, Inc. | 1997 | — |
| −1 | K982339 | Flow 7000 Peripheral Vascular Coil | Usa Instruments, Inc. | 1998 | — |
| 0 (this device) | K023247 | Champion 5000 Peripheral Vascular Coil | Usa Instruments, Inc. | 2002 | — |
| +1 | K042207 | 11000 Rapture Phased Array Peripheral Vascular Coil | Usa Instruments, Inc. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 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 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? (1)
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 |
|---|---|---|---|
| * | K982339 | Flow 7000 Peripheral Vascular CoilSummary page 2…maging of the -Similar to the Flow 7000 Peripheral Vascular Coil vasculature and softtissue anatomy manufactured by USA Instruments, Inc. (K982339) extending from the torso to the foot region Indications for Use: Identical to routine -Similar to the Flow 700… | 1998 |
| † | K964531 | Profile 70000 Quadrature Volume Neck Coil | 1997 |
| † | K000002 | Magna 5000 Phased Array CTL Spine Coil | 2000 |
| † | K000437 | Interventional Body Coil | 2000 |
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 |
|---|---|---|---|
| K042207 | 11000 Rapture Phased Array Peripheral Vascular Coil | 2004 | 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 5 years and passes through 2 companies; a new generation was cleared every 4.3 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K042207 (Usa Instruments, Inc., 2004) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K982339.
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 Champion 5000 Peripheral Vascular Coil is designed to provide Magnetic Resonance Images of the vasculature and soft tissue anatomy, extending from the torso to the foot region. Champion 5000 Peripheral Vascular Coil is designed for use with the Hitachi Altaire 0.7T scanner manufactured by Hitachi Medical Systems America, Inc. Anatomic Regions: vasculature and soft tissue anatomy, extending from the torso to the foot region. Nuclei Excited: Hydrogen…
Read the full statement (155 words)
The Champion 5000 Peripheral Vascular Coil is designed to provide Magnetic Resonance Images of the vasculature and soft tissue anatomy, extending from the torso to the foot region. Champion 5000 Peripheral Vascular Coil is designed for use with the Hitachi Altaire 0.7T scanner manufactured by Hitachi Medical Systems America, Inc.
Anatomic Regions: vasculature and soft tissue anatomy, extending from the torso to the foot region.
Nuclei Excited: Hydrogen
The indications for use are the same as for standard imaging:
The 1.5T MRI 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 T I, 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 as stated in the FDA summary.
https://510kreport.com/device/K023247 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023247: Champion 5000 Peripheral Vascular Coil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023247
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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