# K013894: Tansmit/Receive Quadrature Body Coil 3.0T

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems North America, Inc.
- Decided: Jan 18, 2002 after 56 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 K001796 (2000). 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)
- K001796: Gyroscan Intera (R7.5), Philips Medical Systems North America, Inc. (2000) Summary page 2.

## Indications for use
The indication for use for the Transmit/Receive Quadrature Body Coil 3.0T expands the INTERA 3.0T system capability as a diagnostic device that produces transverse, sagittal, coronal and oblique cross-sectional images based upon 'H metabolites, and that displays the internal structure of the whole body. These images when interpreted by a trained physician, yield information that may assist in diagnosis

Source page: https://510kreport.com/device/K013894
Methodology: https://510kreport.com/methodology