# K964820: Maxim 7000 Quadrature Extremity Coil Model Number Qec-Gem-15A

- Pathway: 510(k) (Traditional)
- Applicant: Us Asia Instruments, Inc.
- Decided: Feb 28, 1997 after 88 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). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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.
- K943440: Profile 7000 C-Spine Coil, Us Asia Instruments, Inc. (1995) Summary page 2.

## Indications for use
The Quadrature Extremity Coil is a receive-only quadrature RF coil, used for obtaining diagnostic images of the elbow anatomy in Magnetic Resonance Imaging systems. The indications for use are the same as for standard MR Imaging.

Source page: https://510kreport.com/device/K964820
Methodology: https://510kreport.com/methodology