# K120290: Toshiba 1.5T Cardiac Coil

- Pathway: 510(k) (Traditional)
- Applicant: Quality Electrodynamics
- Decided: Feb 28, 2012 after 28 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 K061952 (2006). 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)
- K061952: Cardiovascular Array Coils, Models Cac-63-16, Cac-63-32, Cac-123-32 and Cac-127-16, Invivo (2006) Summary page 2.

## Indications for use
The Toshiba 1.5T Cardiac coil is intended for use with the Toshiba 1.5T Vantage MRI system to produce diagnostic images of the heart that can be interpreted by a trained physician.

Source page: https://510kreport.com/device/K120290
Methodology: https://510kreport.com/methodology