510(k) · Cleared
ClearedBody Array 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 22, 2002 as substantially equivalent to K001209 (Usa Instruments, Inc., 2000) and 1 other predicate after an 84-day review. Its family tree reaches back 1 generation to 2000. 6 later devices descend from it.
- Decided
- Jan 22, 2002
- Review
- 84 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K001209 (2000). 2 ancestors in all. 6 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK001209 Insight Plus 9000 Phased Array Torso and Pelvis CoilUsa Instruments, Inc. · 2000
- This deviceK013594 Body Array CoilUsa Instruments, Inc. · 2002
- Descendant · cites it directly · 2 of its ownK024187 Spirit Iii Totalsense Cardiac CoilUsa Instruments, Inc. · 2003
- Descendant · 2 generations on · 1 of its ownK031172 Spirit Iii Totalsense Cardiac CoilUsa Instruments, Inc. · 2003
- Descendant · cites it directly · 1 of its ownK030371 Prima Iii Totalsense Torso CoilUsa Instruments, Inc. · 2003 · Recalled
- Descendant · 2 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
- Descendant · 3 generations on · 0 of its ownK033490 Spirit 5000 Cardiac CoilUsa Instruments, Inc. · 2004
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K024187Spirit Iii Totalsense Cardiac CoilUsa Instruments, Inc. · 2003 · cites it directly2descendants
- K031172Spirit Iii Totalsense Cardiac CoilUsa Instruments, Inc. · 2003 · 2 generations on1descendant
- K030371Prima Iii Totalsense Torso CoilUsa Instruments, Inc. · 2003 · cites it directly1descendant
- K103365Discovery 3T 16 CH Body Array Coil (Anterior); Discovery 3T 16 CH Body Array Coil…Ge Healthcare Coils (Usa Instruments, Inc.) · 2011 · 2 generations on0descendants
- K033490Spirit 5000 Cardiac CoilUsa Instruments, Inc. · 2004 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K001209 | Insight Plus 9000 Phased Array Torso and Pelvis Coil | Usa Instruments, Inc. | 2000 | — |
| 0 (this device) | K013594 | Body Array Coil | Usa Instruments, Inc. | 2002 | — |
| +1 | K024187 | Spirit Iii Totalsense Cardiac Coil | Usa Instruments, Inc. | 2003 | — |
| +2 | K031172 | Spirit Iii Totalsense Cardiac Coil | Usa Instruments, Inc. | 2003 | — |
| +1 | K030371 | Prima Iii Totalsense Torso Coil | Usa Instruments, Inc. | 2003 | 1 |
| +2 | K103365 | Discovery 3T 16 CH Body Array Coil (Anterior); Discovery 3T 16 CH Body Array… | Ge Healthcare Coils (Usa Instruments, Inc.) | 2011 | — |
| +3 | K033490 | Spirit 5000 Cardiac Coil | Usa Instruments, Inc. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 4 | 0 |
| 2004 | 1 | 0 |
| 2011 | 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 |
|---|---|---|---|
| * | K001209 | Insight Plus 9000 Phased Array Torso and Pelvis CoilSummary page 2…ntended Use Torso Imaging including abdomen, chest, lumbar and thoracic spine -Similar to Insight Plus 9000 Torso and Pelvis Coil manufactured by USA Instruments, Inc. (K001209) -Similar to Vision 5000 Phased Array Torso Coil manufactured by USA Instruments, Inc. (K002482) Indications for Use Identical… | 2000 |
| * | K002482 | Vision 9000 Phased Array Torso CoilSummary page 2…t Plus 9000 Torso and Pelvis Coil manufactured by USA Instruments, Inc. (K001209) -Similar to Vision 5000 Phased Array Torso Coil manufactured by USA Instruments, Inc. (K002482) Indications for Use Identical to routine MRI imaging -Similar to Vision 5000 Phased Array Torso Coil manufactured by USA Instr… | 2000 |
What descends from it? (6)
3 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?
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 Body Array Coil is designed to provide Magnetic Resonance Images of the torso region including the abdomen, thoracic, and lumbar spine anatomy. The Body Array Coil is designed for use with the Siemens Rhapsody 1.0Tesla scanner. The indications for use are the same as for standard imaging: The Siemens Rhapsody 1.0Tesla 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 Body Array Coil is designed to provide Magnetic Resonance Images of the torso region including the abdomen, thoracic, and lumbar spine anatomy. The Body Array Coil is designed for use with the Siemens Rhapsody 1.0Tesla scanner.
The indications for use are the same as for standard imaging:
The Siemens Rhapsody 1.0Tesla 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K013594 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013594: Body Array Coil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013594
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026