510(k) · Cleared
Recalled · 2004Prima Iii Totalsense 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 May 5, 2003 as substantially equivalent to K013594 (Usa Instruments, Inc., 2002) and 1 other predicate after a 90-day review. Its family tree reaches back 2 generations to 2000. 1 later device descends from it. It has been recalled once.
- Decided
- May 5, 2003
- Review
- 90 days
- Class
- Class II
- Product code
- MOS
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to K001209 (2000). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK001209 Insight Plus 9000 Phased Array Torso and Pelvis CoilUsa Instruments, Inc. · 2000
- 1 generation backK013594 Body Array CoilUsa Instruments, Inc. · 2002
- This deviceK030371 Prima Iii Totalsense Torso CoilUsa Instruments, Inc. · 2003
- Descendant · cites it directly · 0 of its ownK103365 Discovery 3T 16 CH Body Array Coil (Anterior); Discovery 3T 16 CH…Ge Healthcare Coils (Usa Instruments, Inc.) · 2011
Most influential descendants
Showing 1 of 1 · See all- K103365Discovery 3T 16 CH Body Array Coil (Anterior); Discovery 3T 16 CH Body Array Coil…Ge Healthcare Coils (Usa Instruments, Inc.) · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K001209 | Insight Plus 9000 Phased Array Torso and Pelvis Coil | Usa Instruments, Inc. | 2000 | — |
| −1 | K013594 | Body Array Coil | Usa Instruments, Inc. | 2002 | — |
| 0 (this device) | K030371 | Prima Iii Totalsense Torso Coil | Usa Instruments, Inc. | 2003 | — |
| +1 | K103365 | Discovery 3T 16 CH Body Array Coil (Anterior); Discovery 3T 16 CH Body Array… | Ge Healthcare Coils (Usa Instruments, Inc.) | 2011 | — |
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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K013594 | Body Array CoilSummary page 2…tended Use: imaging of the abdominal and -Similar to the Vision 5000 Torso Coil manufactured by pelvic anatomy, including the liver, spleen, USA Instruments, Inc. (K013594). and renal arteries -Similar to the Insight Plus 9000 Phased Array Torso… | 2002 |
| * | K001209 | Insight Plus 9000 Phased Array Torso and Pelvis CoilSummary page 2…0 Phased Array Torso and Pelvis Coil manufactured by USA Instruments, Inc. (K001209). ~ Coil Enclosure Material: - Similar to the Mark 5000 Quadrature Shoulder coi Flame R… | 2000 |
| † | K013854 | Mark 5000 Quadrature Shoulder Coil | 2002 |
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 |
|---|---|---|---|
| K103365 | Discovery 3T 16 CH Body Array Coil (Anterior); Discovery 3T 16 CH Body Array Coil… | 2011 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 19, 2004 | Not classified | Z-0849-04 | Other | A defective capacitor in the Body Array Coil may result in unstable, unreliable performance, with excessive heating of patient's body. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 3 years and passes through 1 company; a new generation was cleared every 1.6 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K103365 (Ge Healthcare Coils (Usa Instruments, Inc.), 2011) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K013594.
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 Prima Ill TotalSENSE Torso Coil is designed to provide Magnetic Resonance Images of the abdominal and pelvic anatomies. The Prima III TotalSENSE Torso Coil is designed for use with the Siemens Magnetom Trio 3.OT MRI scanner manufactured by Siemens Medical Solutions, Inc. Anatomic Regions: the abdominal and pelvic anatomy, including the liver, spleen, and renal arteries Nuclei Excited: Hydrogen The indications for use are the same as for standard…
Read the full statement (148 words)
The Prima Ill TotalSENSE Torso Coil is designed to provide Magnetic Resonance Images of the abdominal and pelvic anatomies. The Prima III TotalSENSE Torso Coil is designed for use with the Siemens Magnetom Trio 3.OT MRI scanner manufactured by Siemens Medical Solutions, Inc.
Anatomic Regions: the abdominal and pelvic anatomy, including the liver, spleen, and renal arteries
Nuclei Excited: Hydrogen
The indications for use are the same as for standard imaging:
The 3.OT 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/K030371 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030371: Prima Iii Totalsense 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/K030371
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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