# K972340: Insight 7000 Phased Array Torso Coil

- Pathway: 510(k) (Traditional)
- Applicant: Usa Instruments, Inc.
- Decided: Aug 21, 1997 after 58 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 K893619 (1989). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962677: Esteem 1.5T Mri System, Elscint Mr, Inc. (1996) Summary page 2.
- K944469: General Purpose Flex Coil, Philips Medical Systems (Cleveland), Inc. (1995) Summary page 2.
- K960497: Flexible Phased Array Spine Coil, Philips Medical Systems (Cleveland), Inc. (1996) Summary page 2.

## Indications for use
The Insight 7000 Phased Array Torso Coil is designed to provide Magnetic Resonance Images of the torso region. The Insight 7000 Phased Array Torso Coil is designed for use with the Elscint MR’s Esteem 1.5T scanner. The indications for use are the same as for standard imaging: The Esteem 1.5T 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/K972340
Methodology: https://510kreport.com/methodology