510(k) · Cleared
ClearedSpirit 5000 Cardiac 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 Jan 9, 2004 as substantially equivalent to K031172 (Usa Instruments, Inc., 2003) and 1 other predicate after a 66-day review. Its family tree reaches back 4 generations to 2000.
- Decided
- Jan 9, 2004
- Review
- 66 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K001209 (2000). 8 ancestors in all, the oldest K000437 (2000). No later device cites it as a predicate yet.
- Root · 4 generations backK001209 Insight Plus 9000 Phased Array Torso and Pelvis CoilUsa Instruments, Inc. · 2000
- 3 generations backK013594 Body Array CoilUsa Instruments, Inc. · 2002
- 2 generations backK024187 Spirit Iii Totalsense Cardiac CoilUsa Instruments, Inc. · 2003
- 1 generation backK031172 Spirit Iii Totalsense Cardiac CoilUsa Instruments, Inc. · 2003
- This deviceK033490 Spirit 5000 Cardiac CoilUsa Instruments, Inc. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K001209 | Insight Plus 9000 Phased Array Torso and Pelvis Coil | Usa Instruments, Inc. | 2000 | — |
| −3 | K013594 | Body Array Coil | Usa Instruments, Inc. | 2002 | — |
| −2 | K024187 | Spirit Iii Totalsense Cardiac Coil | Usa Instruments, Inc. | 2003 | — |
| −1 | K031172 | Spirit Iii Totalsense Cardiac Coil | Usa Instruments, Inc. | 2003 | — |
| 0 (this device) | K033490 | Spirit 5000 Cardiac Coil | Usa Instruments, Inc. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2003 | 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? (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 |
|---|---|---|---|
| * | K031172 | Spirit Iii Totalsense Cardiac CoilSummary page 2…nded Use: imaging of the -Similar to the Spirit Ill TotaISENSE Cardiac Coil cardiovascular system manufactured by USA instruments, Inc. (K031 172) Indications for Use: Identical to -Similar to the Spirit III TotaISENSE Cardiac Coil routine MRI imaging… | 2003 |
| * | K000437 | Interventional Body CoilSummary page 2…ne MRI imaging manufactured by USA Instruments, Inc. (K031 172) -Similar to the Interventiona[ Body Coil (K000437) manufactured by USA Instruments, Inc. Coil Enclosure Material: -Simi… | 2000 |
What descends from it?
No later submission names this one as a predicate yet.
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 4 years and passes through 1 company; a new generation was cleared every 1.0 years on median.
- None of the 8 ancestors has a recall.
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 Spirit 5000 Cardiac Coil is designed to provide Magnetic Resonance Images of the cardiovascular system. The Spirit 5000 Cardiac Coil is designed for use with the Hitachi Altaire 0.7T MR scanner manufactured by Hitachi Medical Systems, Inc. The indications for use are the same as for standard imaging: The 0.7T MRI system is indicated for use as an NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR…
Read the full statement (124 words)
The Spirit 5000 Cardiac Coil is designed to provide Magnetic Resonance Images of the cardiovascular system. The Spirit 5000 Cardiac Coil is designed for use with the Hitachi Altaire 0.7T MR scanner manufactured by Hitachi Medical Systems, Inc.
The indications for use are the same as for standard imaging:
The 0.7T 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 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 as stated in the FDA summary.
https://510kreport.com/device/K033490 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033490: Spirit 5000 Cardiac Coil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033490
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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