# K961391: Flexart QD Head/Neck Coil

- Pathway: 510(k) (Traditional)
- Applicant: Toshiba America Mri, Inc.
- Decided: Jul 9, 1996 after 90 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 K933018 (1994). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K933018: MRT-50GP, Toshiba America Mri, Inc. (1994) Summary page 2.

## Indications for use
General disease and vascular imaging of the head and cervical regions

Source page: https://510kreport.com/device/K961391
Methodology: https://510kreport.com/methodology