# K983139: Signa 1.5T Phosphorus (P) Transmit/Receive Flex Coil

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems
- Decided: Feb 19, 1999 after 164 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 K923264 (1992). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962061: Magnetic Resonance Diagnostic System, GE Medical Systems (1996) Summary page 1.
- K930265: Hydrogen Spectroscopy Option-Probe #M1040HS/HT, GE Medical Systems (1995) Summary page 1.
- K923264: General Purpose Flex Coil, General Electric Co. (1992) Summary page 1.

## Indications for use
The Signa® 1.5T Phosphorus (*'P) Transmit/Receive Flex Coil is intended to operate with the Signa® 1.5T Magnetic Resonance System. The coil is simply to improve the signal-to-noise performance of the MR system in specific anatomical areas. The Signa® 1.5T Phosphorus (*'P) Transmit/Receive Flex Coil is intended for general diagnostic use to present magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance of phosphorus (*'P) spectra.

Source page: https://510kreport.com/device/K983139
Methodology: https://510kreport.com/methodology