# K030371: Prima Iii Totalsense Torso Coil

- Pathway: 510(k) (Traditional)
- Applicant: Usa Instruments, Inc.
- Decided: May 5, 2003 after 90 days
- Product code: MOS (Coil, Magnetic Resonance, Specialty)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K001209 (2000). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013594: Body Array Coil, Usa Instruments, Inc. (2002) Summary page 2.
- K001209: Insight Plus 9000 Phased Array Torso and Pelvis Coil, Usa Instruments, Inc. (2000) Summary page 2.

## Most influential descendants
- K103365: Discovery 3T 16 CH Body Array Coil (Anterior); Discovery 3T 16 CH Body Array Coil (Posterior); Discovery 3T 32 CH Body a (2011), 0 descendants of its own

## Recalls of this device
- Mar 19, 2004 · Not classified · Z-0849-04: A defective capacitor in the Body Array Coil may result in unstable, unreliable performance, with excessive heating of patient's body.

## Indications for use
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.

Source page: https://510kreport.com/device/K030371
Methodology: https://510kreport.com/methodology