# K031365: Prima Iii Totalsense Torso Coil

- Pathway: 510(k) (Traditional)
- Applicant: Usa Instruments, Inc.
- Decided: Jul 18, 2003 after 79 days
- Product code: MOS (Coil, Magnetic Resonance, Specialty)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: none
- 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.
No later device cites it as a predicate yet.
0 of 4 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)
- K001209: Insight Plus 9000 Phased Array Torso and Pelvis Coil, Usa Instruments, Inc. (2000) Summary page 2.

## Indications for use
The Prima I l l TotalSENSE Torso Coil is designed to provide Magnetic Resonance Images of the abdominal and pelvic anatomies. Thie Prima Ill TotalSENSE Torso Coil is designed for use with the Philips lntera 3.OT MRI scanner manufactured by Philips Medical Systems, 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 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.

Source page: https://510kreport.com/device/K031365
Methodology: https://510kreport.com/methodology