# K964678: Phased Array Neck Coil

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems (Cleveland), Inc.
- Decided: Feb 11, 1997 after 82 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: 1 generation back to K925987 (1993). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K945827: Outlook, Philips Medical Systems (Cleveland), Inc. (1995) Summary page 2.
- K925987: Instrumentarium MEGA4 HT, Instrumentarium Imaging, Inc. (1993) Summary page 2.

## Most influential descendants
- K981959: Outlook Large Phased Array Neck Coil (1998), 0 descendants of its own

## Indications for use
Neck, from the cerebellum to the upper thoracic spine region.

Source page: https://510kreport.com/device/K964678
Methodology: https://510kreport.com/methodology