# K964753: Matrix 3000 Flexible Spine Coil

- Pathway: 510(k) (Traditional)
- Applicant: Us Asia Instruments, Inc.
- Decided: Feb 11, 1997 after 76 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- 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). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960497: Flexible Phased Array Spine Coil, Philips Medical Systems (Cleveland), Inc. (1996) Summary page 3.
- K943440: Profile 7000 C-Spine Coil, Us Asia Instruments, Inc. (1995) Summary page 3.
- K945827: Outlook, Philips Medical Systems (Cleveland), Inc. (1995) Summary page 3.

## Most influential descendants
- K990007: Opart, Model MRT-600 (1999), 0 descendants of its own

## Indications for use
The Flexible Spine Coil is a receive-only phased array RF coil, used for obtaining diagnostic images of the thoracic and lumbar spine in Magnetic Resonance Imaging systems. The indications for use are the same as for standard MR Imaging. The Matrix 3000 Flexible Spine Coil is designed for use with the Outlook (0.23Tesla) MRI scanner manufactured by Picker International Inc.

Source page: https://510kreport.com/device/K964753
Methodology: https://510kreport.com/methodology